Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.

The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company.

“Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of circulatory support research and clinical applications. This FDA approval marks a significant milestone in the treatment of heart disease. The new medical field of heart muscle recovery has begun. Today, Abiomed only treats around 5% of this AMI cardiogenic shock patient population, which suffers one of the highest mortality risks of any patient in the heart hospital. Tomorrow, Abiomed will be able to educate and directly partner with our customers and establish appropriate protocols to improve the patient outcomes focused on native heart recovery,” CEO Michael Minogue said in prepared remarks.

The company claims the Impella line are now the 1st percutaneous temporary ventricular support devices FDA cleared for treating cardiogenic shock. The devices are indicated for short term use, of less than 4 days for the Impella 2.5 and CP models and less than 6 days for the Impella 5.0 and LD models.

Abiomed said product labeling will also allow for the device to be left in place beyond the 4-6 day duration if a clinical decision is made to adjust for unforseen circumstances.

“This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high mortality risk. The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function,” Dr. William O’Neill, of the Henry Ford Hospital said in a prepared statement.

The approval adds to the Impella 2.5’s indication for high risk percutaneous coronary intervention which it won in March last year.

In March, Abiomed said it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of the agency’s advisory panels.

Abiomed said the federal safety watchdog agreed on the indication for treating patients in cardiogenic shock after a heart attack or cardiac surgery with its Impella 2.5, Impella CP, Impella 5.0 and Impella LD devices.

The company said it submitted data from its 415-patient Recover 1 study, a review of data from another 692 patients in 17 trials, and a safety analysis of more than 24,000 patients using the FDA’s medical device reporting database.

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Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy.

The NeuroBlate system is designed to ablate, necrotize or coagulate soft tissue during neurosurgery procedures through laser thermotherapy, and is not intended for any specific disease or lesion type, the company said.

The Plymouth, Minn.-based company said with the clearance it will initiate the multicenter, open-label Flare study, looking to enroll 45 patients at up to 8 clinical sites in the U.S. The trial aims to evaluate 30 patients using laser interstitial thermal therapy for treating drug-refractory medial temporal lobe epilepsy.

“Many refractory epilepsy patients in the U.S. are eligible for resection surgery treatment, but the vast majority of patients and their doctors choose not to undertake such an invasive procedure due to the underlying risks associated with traditional open brain surgery. The Flare study will help to determine whether patients may benefit from a minimally invasive procedure, such as LITT.  Flare is designed to provide important insight into the safety and efficacy of this approach and its potential impact on neurocognition and seizures. This study is an important step forward in evaluating a new modality designed for medically refractory epilepsy,” principal investigator Dr. Dennis Spencer of the Yale University School of Medicine  said in prepared remarks.

The primary endpoint for the study is to characterize the safety of laser ablation surgery with the system as well as the evaluation of adverse events and neuropsychological changes. Seizure outcome and quality of life will serve as secondary endpoints, the company said.

Patients in the trial will undergo laser ablation surgery and be followed for 24 months. Monteris Medical said it expects to iniate the Flare study in the 2nd half of 2016, and will take approximately 3.5 years to complete.

“Refractory epilepsy represents a significant unmet medical need. The Flare study will help increase our understanding of the potential benefit the NeuroBlate system may have on the quality of life of patients living with this serious and debilitating disease,” Monteris Medicals veep of clinical affairs Daryle Petersen said in a press release.

Last November, Monteris Medical said a pair of new backers joined a $30 million Series B round it plans to use to expand the commercial footprint of its NeuroBlate robotic brain tumor laser.

Monteris in April 2013 won 510(k) clearance from the FDA and a nod from Health Canada for the minimally invasive NeuroBlate device, which allows physicians to use an MRI-guided laser system to heat and kill brain tumors.

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Mauna Kea (ENT:MKEA) said yesterday it inked a research collaboration deal with Edinburgh Molecular Imaging to explore the combination of EM Imaging’s in vivo optical imaging agents with Mauna Kea’s confocal laser endomicroscopy platform to diagnose cancer.

EM Imaging said it will supply optical imaging agent EMI-137 to 2 investigational sites to perform clinical efficacy studies in pacnreatic and lung cancers using celular level endomiscroscopy with Mauna Kea’s Cellvizio.

“We have been at the forefront of image-guided surgery with novel molecular markers and advanced imaging modalities for several years. With Cellvizio and EMI-137, we will now enable for the first time highly specific real-time imaging at the cellular level in solid tumors. This combination of molecular markers, targeted macroscopic image-guided surgery/endoscopy and endomicroscopy represents a significant clinical milestone that we are about to embark upon,” Go Van Dam and Dr Wouter Nagengas of the University Medical Center Groningen said in prepared remarks.

The company said that intravenous administration of EMI-137 leads to selective accumulation in c-Met expressing tumors which can be detected optically via fluorescent markers attached to the molecular imaging agent.

“Lung Cancer is the biggest cancer killer in the world and any methodologies that could allow us to improve diagnosis, treatment monitoring and surgical resection are urgently required. We will evaluate the potential impact of Cellvizio and EMI-137 in our patients working alongside surgeons and pulmonologists at the University of Edinburgh,” Dr Kev Dhaliwal of the Royal Infirmary of Edinburgh said in a press release.

In a separate project EM Imaging said it will provide neutrophil targeting optical imaging agent EMI-200 designed for topical administration in the lungs. Mauna Kea said the studies will be performed under an investigator-sponsored emergency investigational new drug clearance at the Cleveland Clinic in acute patients.

“Early detection and verification of disease at the point of care continues to be a major challenge to patient care and management. This collaboration potentially addresses these major unmet medical needs by combining targeted molecular agents with the most advanced imaging technology available to improve disease detection and guide intervention. We look forward to pioneering this approach withMauna Kea and our clinical partners,” EM Imaging CEO Ian Wilson said in a prepared statement.

“Combining our unique endomicroscopy platform with highly-specific molecular markers from EM Imaging is another key milestone in our development strategy to bring in vivo examination to a level never reached by existing standards. We are delighted to partner with EM Imaging and leading clinical institutions such as the UMCG, Cleveland Clinic and Edinburgh with the common goal to revolutionize the way cancer patients are diagnosed. We continue to deliver on our ambitious roadmap and look forward to the first in-human clinical results of this cutting-edge endeavor,” Mauna Kea CEO Sacha Loiseau said in a press release.

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What, exactly, is a fever?

It’s a surprisingly simple but important question in medicine. While a body temperature of 98.6°F (37°C) is generally considered “normal,” this number doesn’t account for temperature differences between individuals — and even within individuals at various times of the day. While a common sign of infection, fever can also occur with other medical conditions, including autoimmune and autoinflammatory diseases.

“Many factors come together to set an individual’s ‘normal’ temperature, such as age, size, time of day and maybe even ancestry,” says Jared Hawkins, MMSc, PhD, the director of informatics for Boston Children’s Hospital’s Innovation & Digital Health Accelerator (IDHA) and a member of the hospital’sComputational Health Informatics Program. “We want to help create a better understanding of the normal temperature variations throughout the day, to learn to use fever as a tool to improve medical diagnosis, and to evaluate the effect of fever medications on symptoms and disease course.”

That’s where Feverprints comes in — a free app developed by IDHA and the Autoinflammatory Diseases Clinic at Boston Children’s to capture temperature data from the public. By leveraging ResearchKit, Apple’s open source software framework, the Feverprints team can gather frequent, accurate data shared from people’s iPhones (iPhone 5, iPhone 6) or the latest generation of the iPod Touch. (Unfortunately, Android users won’t be able to participate.)

After downloading the Feverprints app, adults (and children with parental consent) who join the study will be regularly reminded to record their temperature (using any type of thermometer) and answer questions about their symptoms, medications, lifestyle and health. The data will be anonymized and logged in a secure database. All participants will receive a summary of their data and can share it with their doctors.

Read the full post on Vector: Fever, revisited: ResearchKit app will tap crowd-sourced temperature data

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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A 10-year-old whistleblower lawsuit filed by a former Abbott (NYSE:ABT) sales rep, over the alleged off-label marketing of biliary stents, ended yesterday when a Dallas jury found for Abbott.

Colquitt’s lawyer, Chris Hamilton, said he plans to appeal.

“We believe the evidence supports a finding that Abbott knowingly marketed and billed Medicare hundreds of millions of dollars in stents for unapproved uses that were not eligible for reimbursement under the rules,” Hamilton told Bloomberg.

“The defendants had no clinical trial data that their devices were safe and effective,” he told the jury yesterday. “They didn’t start a clinical trial. They never attempted a clinical trial.”

“Medicare does not assume a device is safe and effective. You have to have the evidence,” Hamilton said.

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Share prices slipped after hours yesterday after AngioDynamics (NSDQ:ANGO) lowered its outlook for the rest of fiscal 2016, despite a swing to profits on better-than-expected fiscal 3rd-quarter results.

Latham, N.Y.-based AngioDynamics, which ousted former president & CEO Joe DeVivo earlier this week, posted profits of $630,000, or 2¢ per share, on sales growth of 0.9% to $87.4 million for the 3 months ended Feb.29. That compares with Q3 2015 losses of -$4.3 million, or -12¢ per share.

Adjusted to exclude 1-time items, earnings per share were 15¢, a penny ahead of the consensus forecast on Wall Street.

“I believe there is a strong market opportunity for our products and a solid foundation upon which to grow,” James Clemmer, the ex-Covidien bigwig appointed to replace DeVivo, said in prepared remarks. “My focus will be to put us on a pathway toward sustainable and profitable growth through disciplined execution, efficient resource allocation and value-driven innovation.”

“Third-quarter results met our expectations, but top-line growth rates continue to reflect ongoing headwinds that we are facing, including competitive dynamics in vascular access, reimbursement challenges and slower growth internationally,” added interim CFO Michael Trimarchi. “The peripheral vascular business grew 8%, and included AngioVac growth of 28%. Demand for BioFlo continued during the quarter, which saw growth across all product segments in the vascular access business, and now represents 42% of the franchise. In oncology/surgery, our higher-margin growth driver products, Microwave and NanoKnife, continued to show procedural and utilization growth offsetting slower capital sales.”

AngioDynamics cut its forecast for the rest of the fiscal year, saying it now expects to report adjusted EPS of 54¢ to 58¢ on sales of $347 million to $350 million, down from 59¢ to 63¢ on sales of $353 million to $359 million previously. Fourth-quarter adjusted EPS are pegged at 14¢ to 18¢ on sales of $87 million to $90 million.

Investors sent ANGO shares down -2.3% to $11.35 apiece in after-hours trading yesterday, from an $11.62 close.

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EmboMedics said it raised a $4.3 million Series A1 round for the bioresorbable embolization microspheres it’s developing.

Maple Grove, Minn.-based EmboMedics said it plans to use the proceeds to pursue pre-market approval for a drug-delivery device, co-founder & CEO Omid Souresrafil said in prepared remarks. The infusion is enough to carry the company through 2018, Souresrafil said.

The company’s microsphere technology came out of the University of Minnesota lab run by co-founder & chief medical officer Dr. Jafar Golzarian, EmboMedics said. The company is targeting treatments for the prostate, uterine fibroid tumors and liver cancer.

EmboMedics said in a regulatory filing that the A1 round, launched last July, included contributions from 29 unnamed investors.

“We thank all of our Investors including our angels and private investors for their trust in our team and technology,” Souresrafil said.

A year ago, AngioDynamics (NSDQ:ANGO) put $11 million on the table for the licensing rights to EmboMedics microspheres, including an initial $2 million equity investment and another possible $9 million investment and exclusive option to buy.

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Mach7 Technologies said today that it closed its $60 merger with 3D Medical (ASX:3DM), saying it will begin trading on the Australian Stock Exchange under the “M7T” symbol.

The deal unites Mach7’s enterprise image management offerings with 3D Medical’s medical 3D printing.

“Our commitment to customer-driven design remains the core of our culture and the soul of our business philosophy,” Mach7 managing director & CEO Albert Liong said in prepared remarks. “We are a company born of innovation and growing through extraordinary collaboration to bring advanced enterprise data management and medical solutions to our expanding network of customers, healthcare communities and globally connected healthcare ecosystems.”

“The combined strength of our 2 organizations will enhance our ability to serve a large healthcare market with ground-breaking medical technology applications for improved patient care,” added CFO Jenni Pilcher.

Mach7 said it plans to keep its headquarters in Burlington, Vt., as it looks to expand its sales footprint in Australia, New Zealand and Western Europe.

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Share prices for China’s Dehaier Medical Systems (NSDQ:DHRM) jumped today after it released preliminary numbers for last year, despite massive losses incurred as it sheds unprofitable medical device businesses.

Beijing-based Dehaier said in February that it plans to ditch the medtech units to focus on its wearable sleep respiratory business. Today the company reported preliminary losses of -$36 million, or -$6.13 per share, on sales of $1.32 million for 2015, compared with profits of $1 million last year. Sales are slated to be off by -67.6% compared with 2014, Dehaier said.

Full results are due to drop some time this month, the company said.

The restructuring plan calls for Dehaier to bail out of the assembly and sale of X-ray and anesthesia machines, but retain its medical air compressor and CPR instruments businesses.

“Specifically, we continued scaling down and discontinuing, as appropriate, the unprofitable medical device businesses, including assembly and sales of mobile C-arm X-ray machines, anesthesia machines, Oxygen generator, the first generation ventilator, monitoring devices, general medical products and telemedicine products,” CEO Ping Chen said in prepared remarks. “Accordingly, the company wrote down the carrying value of the assets associated with the discontinued product lines and besides sleep respiratory business and hospital wireless solutions, the company plans to maintain only a few profitable traditional medical device businesses, such as sales of its patented products including medical air compressors and CPR instruments, the second generation ventilator, color Doppler imaging machine, laryngoscope, and common products.”

The company has said it plans to form a new subsidiary called Connection Wearable Health Technology by the end of this month, aiming to focus on “wearable sleep respiratory and mobile health related businesses.”

“Our corporate and business restructuring plan aims to concentrate the company’s resources to develop its mobile health business, including wearable sleep respiratory business and to focus more on its major businesses. We believe these changes are crucial to improve our competitiveness over the longer term. By restructuring our company to reduce our reliance on our less profitable medical devices assembly and distribution businesses, we will be more able to leverage our resources to develop smart health products and services, which we see as the future of our company,” Chen said.

Late last year Dehaier said it was considering a $20 million equity investment offer from Hangzhou Liaison Interactive Information Technology.

DHRM shares were up 6.9% to $1.82 apiece today in late-morning trading.

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Windgap Medical said in a regulatory filing today that it raised a debt-and-options round worth $2.9 million for the epinephrine auto-injector it’s developing.

Somerville, Mass.-based Windgap is working on a device that would mix a dry formulation of the drug into solution, then inject it into a patient suffering from anaphylaxis due to an acute allergy attack.

The device is designed to be smaller than the market leading EpiPen made by Mylan (NSDQ:MYL) and eliminate the shelf life problems associate with liquid epinephrine.

The funding round involved 46 unnamed investors, according to the filing.

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Grifols (NSDQ:GRFS) said today that it agreed to pay $100 million for a 49% stake in plasma collector Interstate Blood Bank.

The deal includes an option to buy the remaining 51% for another $100 million and a $10 million call option, Barcelona-based Grifols said.

IBB collects blood plasma so that is can be fractionated into blood serum products. Grifols said it expects to close the deal “within the month.”

The Spanish conglomerate makes plasma-derived protein therapies and products and IV solutions for hospital pharmacies, hospitals and laboratories.

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

5. Monteris wins FDA IDE clearance for NeuroBlate trial

Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy.

The NeuroBlate system is designed to ablate, necrotize or coagulate soft tissue during neurosurgery procedures through laser thermotherapy, and is not intended for any specific disease or lesion type, the company said. Read more

4. Report: Hospitals doubt medtech can help meet CMS outcome goals

While the Affordable Care Act could lead to improved partnerships between medtech manufacturers and hospitals, a new survey and report from ZS Associates indicates that hospital execs aren’t convinced that such partnerships will help them meet their needs.

The passing of the ACA has led to a shift in focus in the healthcare industry towards patient outcomes, which means that medtech companies will need to transition from serving merely as suppliers to becoming partners with hospitals, according to the report. Read more

3. EmboMedics raises $4.3m for embolization microbeads

EmboMedics said it raised a $4.3 million Series A1 round for the bioresorbable embolization microspheres it’s developing.

Maple Grove, Minn.-based EmboMedics said it plans to use the proceeds to pursue pre-market approval for a drug-delivery device, co-founder & CEO Omid Souresrafil said in prepared remarks. The infusion is enough to carry the company through 2018, Souresrafil said. Read more

2. Abbott prevails in 10-year-old stent lawsuit

A 10-year-old whistleblower lawsuit filed by a former Abbott sales rep, over the alleged off-label marketing of biliary stents, ended yesterday when a Dallas jury found for Abbott.

Plaintiff Kevin Colquitt, a former rep for Abbott’s Guidant division, sued Abbott, Johnson & Johnson and Boston Scientific in 2006, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing the lawsuit, Judge Barbara Lynn of the U.S. District Court for Northern Texas, later let J&J and Boston Scientific off the hook.) Read more

1. FDA approves Abiomed’s Impella with indication for cardiogenic shock

Abiomed said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.

The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company. Read more

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MTD Micro Molding (www.mtdmicromolding.com), a long-time leader in micro-injection molding for the medical device industry, invests in additional capacity in their in-house tooling and molding departments with the purchase of new equipment and upgrades.

The molding department will be adding two 20-ton Sodick molding presses with ancillary equipment to the existing Class 8 certified cleanrooms, including full automation and in-line inspection.

In addition to the molding expansion, MTD has purchased a new CMM (coordinate measuring machine) and a high-speed milling machine to support the in-house tooling department. MTD is specialized in designing and constructing 100% of micromolding tools in-house, allowing the technological handshake between tooling and molding to result in superior products, shorter lead-times, and better project management.

“I am really looking forward to the CMM machine because it will allow us to level up our tooling accuracy even higher”, said Gary Hulecki, Executive VP at MTD Micro Molding. MTD’s current workpiece accuracy target is 42 millionths, which enables part features like .002” wall thicknesses, aspect ratios of 250:1, zero draft, and tip radii of 5 microns to exist. This precision will only improve with this new piece of equipment. “As a company, we are poised for significant growth and these investments mark the beginning of that transition”, he added.

MTD Micro Molding
mtdmicromolding.com

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Medtronic (NYSE:MDT) yesterday disputed a newspaper’s report about an internal review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, saying the piece made false insinuations and omitted key facts.

The Minneapolis Star Tribune reported yesterday that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– including about 1,000 adverse event reports and 4 deaths – within 30 days, as the federal safety watchdog requires. The Fridley, Minn.-based company instead shut down the review in 2008; company executives said the adverse events database compiled from the review was misfiled but eventually reported to the FDA in 2013, according to the newspaper.

The 5-year delay failed to draw any flags at the FDA, which redacted the number of adverse events from a public, 3-sentence summary. The data was only released after the Star Tribune filed a Freedom of Information Act request was granted in September 2015.

Doctors who reported the 4 deaths said they were not related to the use of Infuse (including 2 patients with heart conditions, 1 who died from cancer and another from abdominal inflammation). Although Medtronic revealed “a small slice” of the data in a 2008 bid to expand the indication for Infuse, but the FDA would not accept it as evidence, according to the Star Tribune.

“To this day, neither the company nor the FDA has publicly disclosed full details of the study,” the newspaper reported.

Medtronic said it acknowledged that results from its review were not properly archived nor fully assessed for reportability to the FDA, but that once the data was located in 2013 it was promptly reported “to all appropriate regulatory bodies.” The data does not change the safety and efficacy for Infuse, the company said.

“Despite these facts the article suggests Medtronic attempted to conceal information about the [retrospective chart review], including information about adverse events reported in the data. This suggestion is false, and we want to set the record straight by sharing details that were provided to the Star Tribune but omitted from the article,” Medtronic said in a prepared release. “We have fully lived up to our principles of transparency and disclosure.”

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Boston Scientific (NYSE:BSX) recalled the Fetch 2 aspiration catheter it acquired from Bayer (ETR:BAYN) in 2014, after receiving complaints of shaft breakage during coronary thrombectomy procedures.

There were no injuries or deaths reported from the shaft breakage and there is no risk to patients who have already had thrombectomies using the Fetch 2 device, Marlborough, Mass.-based Boston Scientific said. The Class I recall, the FDA’s designation for problems that could cause serious injury or death, affects all 21,155 of the Fetch 2 catheters the company has on the market.

Boston Scientific closed the $415 million cash buyout Bayer’s interventional unit in September 2014. The deal added atherectomy and thrombectomy devices including the Fetch 2, the AngioJet thrombectomy system and the JetStream atherectomy device to the BSX portfolio. the recalled devices still bear the Bayer label, Boston Scientific said April 8.

The shaft breakage incidents that prompted the March 22 recall were all resolved without further complications, by either removing the broken section while it was still partially attached to the catheter shaft or by using a snare on detached particles, the company said. The main risk related to the March 22 recall is embolism of device fragments, “which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically,” Boston Scientific said.

Healthcare providers should immediately stop using all Fetch 2 devices and return any unused products to Boston Scientific, the company said. The affected devices were made between June 11, 2014, and February 19 and carry the following universal product numbers:

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St. Jude Medical (NYSE:STJ) today announced the U.S. debut of its Axium neurostimulator system, after the device won FDA approval in February for treating chronic pain.

The 1st patients were implanted in West Virginia and California with the Axium device, which uses dorsal root ganglion stimulation to treat moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome, St. Jude said. The Axium is slated to be implanted in 25 states in the coming weeks, with 100 procedures due in the 1st month after launch, the Little Canada, Minn.-based company said.

“Since the approval of dorsal root ganglion stimulation with the Axium system in February 2016, we have focused on a strategic rollout with a disciplined training program for physicians across the country. We believe this approach ensures patient access to this highly effective new therapy to help manage their chronic pain,” vice president Dr. Allen Burton said in prepared remarks. “The 1st Axium system implants in the United States reflect our ongoing commitment to working with our physician partners to deliver on our promise to transform the treatment of chronic pain.”

St. Jude said it aims to train more than 300 surgeons on implanting the Axium device this year.

“Although many chronic pain patients can find relief from a traditional spinal cord stimulation device, many patients suffering from focal chronic pain including CRPS I and II don’t receive adequate pain relief from spinal cord stimulation,” said Dr. Timothy Deer, of Charleson, W.Va.’s Center for Pain Relief, 1 of the 1st to implant Axium. “Adding dorsal root ganglion stimulation with the Axium neurostimulator system to my therapeutic arsenal is an exciting step in the treatment of chronic intractable pain of the groin, knee and foot. I’m impressed with the speed in which I am able to reach and stimulate the dorsal root ganglion, something I was unable to do before the Axium neurostimulator system. For the 1st time, I now have a device designed specifically for the large and growing number of under-treated chronic pain patients I could not previously serve.”

“Stimulation of the dorsal root ganglion is the 1st therapy option designed specifically for patients suffering from complex regional pain syndromes. This serious and traditionally challenging to treat chronic pain condition can occur from complications to recovery from surgeries such as knee arthroscopy, foot surgery or hernia surgery,” added Dr. Jason Pope of Santa Rosa, Calif.-based Sutter Santa Rosa Surgery & Endoscopy Center, another 1st implanter for Axium. “Having a treatment option rooted in clinical evidence fundamentally changes our approach to treating patients. I am thrilled to be among the 1st in the United States to offer previously underserved patients this revolutionary technology.”

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CeQur is looking to treble the size of its workforce in Massachusetts with an expansion of the plant in Marlborough it plans to use to make the PaQ insulin device it hopes to launch this year.

PaQ, a patch-like device, is designed to deliver both basal insulin and on-demand bolus insulin over 3 days. CeQur says it’s optimized the device for high-volume, low-cost manufacturing ahead of the planned commercialization of the 2nd generation this year. The 1st-generation PaQ device won CE Mark approval in the European Union in November 2012.

CeQur, which is based in Marlborough and Lucerne, Switzerland, said today that it’s expanding its Bay State home to 25,000 square feet later this year, and plans to take its workforce there from 50 to 150 employees over the next 2 years.

“Over the past year, we’ve optimized PaQ for high-volume, low-cost manufacturing and continued to amass clinical evidence that demonstrate PaQ will offer a safe, simple-to-use and cost-effective alternative to daily insulin injections for people with Type II diabetes,” CEO Doug Lawrence said in prepared remarks. “We are excited to be expanding our facilities here in Marlborough in preparation for the market introduction of PaQ.

“Marlborough has been our U.S. base since CeQur was founded, and we’ve been extremely pleased with the resources available to us here, as well as the support we’ve received from the robust Massachusetts life-sciences and medical device community,” Lawrence added. “We are confident that this is the best place to continue to build our company and capabilities.”

The plant expansion was due to be celebrated today in a “wall-breaking” ceremony attended by Mass. Gov. Charlie Baker (R) and other state and private-sector officials.

“The continued investment and expansion of companies like CeQur speaks to Massachusetts’ leadership in life sciences and the medical device industry,” Baker said in a press release. “The expansion of their facility in Marlborough and creation of new job opportunities is important not only to the people of the Commonwealth, but all those who can benefit from continued advancements in treatments for diabetes around the world.”

Last September CeQur raised a Series C round worth $100 million in what its backers called the largest medtech financing in Europe since 2006. The company raised $27 million in a Series B round in April 2014 and closed a $30 million Series A round back in January 2010.

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Vascular Solutions (NSDQ:VASC) said today it initiated a recall of its Guardian II hemostasis valves designed for use in catheterization procedures over an increased risk of air leakage that could lead to air embolism.

The Minneapolis, Minn.-based company said the FDA labeled the recall as a Class I, the agency’s most serious classification of recall, which is used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The recall only affects the Guardian II hemostasis valves and does not include Guardian II NC hemostasis valves, the company said in a press release, saying air embolisms in the recalled valve could potentially result in serious injury or death.

Vascular Solutions said it has not received any reports of injury or adverse events related to the issue to date, and instructed healthcare facilities with affected units to remove the products from their inventory and return them to the company.

A total of 26,550 devices were affected by the recall, manufactured between March 2015 and February 2016 and distributed between April 2015 and February 2016, the company said.

The recalled products are specific lots of model numbers 8210 and 8211, with 5,283 units distributed in the U.S. Only approximately 2.4% of the devices are affected by the recall, Vascular Solutions said.

The recall was voluntarily initiated by Vascular Solutions on March 3 through an urgent medical device recall notification distributed to purchasers of the affected products.

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Boston Scientific‘s (NYSE:BSX) new medical device manufacturing plant in Batu Kawan Industrial Park in Penang, Malaysia is set to open in the 4th quarter of 2017, according to Malaysia’s StarBiz paper.

Construction of the new facility is slated to begin in the 1st half of 2016 with a planned completion in the 2nd half of 2017, according to the paper.

“The plant will be operational in the 4th quarter of 2017, and we expect to ship our first “Made-in-Malaysia” product before the end of 2017,” operations veep Dave Mitchell told StarBiz.

The site and facility is being designed to accommodate “at least 10 years of growth” including new products, volume and capabilities that could include R&D, the paper said.

“We anticipate having more than 400 employees at the Penang site within four years of operation, with room to grow significantly beyond that. Initially we will focus on building manufacturing capability and capacity in the Penang facility. We have the space and ability for additional capabilities at the site, including both R&D and distribution,” Mitchell said.

Mitchell said that, according to the research group Euromonitor, the 2016 medical device industry is slated to see growth of 6% to reach $315 billion.

“Unlike the traditional markets such as Western Europe and the U.S., the Asia-Pacific medical device market is projected to to grow and gain a wider market in 2016,” Mitchell told StarBiz.

Last month, Boston Scientific and the Mayo Clinic  revealed a 3-year-old development program that has about a dozen new products in the pipeline, including a centering catheter for replacement heart valves and a heart failure application for the Precision Spectra spinal cord stimulator.

Four of the roughly 12 products in the hush-hush program, reportedly winnowed from a field of 50 initial ideas, are expected to reach the 1st-in-human trial stage this year. A Boston Scientific executive said the repeal of the medical device tax this year allowed it to take its spend on the program into the multi-million-dollar range.

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Grifols puts up $100m for a 49% stake in Interstate Blood Bank

Grifols said that it agreed to pay $100 million for a 49% stake in plasma collector Interstate Blood Bank.

The deal includes an option to buy the remaining 51% for another $100 million and a $10 million call option, Barcelona-based Grifols said. Read more

4. Vascular Solutions initiates voluntary recall of Guardian II valve

Vascular Solutions said today it initiated a recall of its Guardian II hemostasis valves designed for use in catheterization procedures over an increased risk of air leakage that could lead to air embolism.

The Minneapolis, Minn.-based company said the FDA labeled the recall as a Class I, the agency’s most serious classification of recall, which is used when there is a reasonable probability that product use could cause serious adverse health consequences or death. Read more

3. St. Jude Medical’s Axium chronic pain device makes its U.S. debut

St. Jude Medical today announced the U.S. debut of its Axium neurostimulator system, after the device won FDA approval in February for treating chronic pain.

The 1st patients were implanted in West Virginia and California with the Axium device, which uses dorsal root ganglion stimulation to treat moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome, St. Jude said. The Axium is slated to be implanted in 25 states in the coming weeks, with 100 procedures due in the 1st month after launch, the Little Canada, Minn.-based company said. Read more

2. Boston Scientific recalls Fetch 2 thrombectomy catheters

Boston Scientific recalled the Fetch 2 aspiration catheter it acquired from Bayer in 2014, after receiving complaints of shaft breakage during coronary thrombectomy procedures.

There were no injuries or deaths reported from the shaft breakage and there is no risk to patients who have already had thrombectomies using the Fetch 2 device, Marlborough, Mass.-based Boston Scientific said. The Class I recall, the FDA’s designation for problems that could cause serious injury or death, affects all 21,155 of the Fetch 2 catheters the company has on the market. Read more

1. Medtronic disputes newspaper’s Infuse story

Medtronic yesterday disputed a newspaper’s report about an internal review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, saying the piece made false insinuations and omitted key facts.

The Minneapolis Star Tribune reported yesterday that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– including about 1,000 adverse event reports and 4 deaths – within 30 days, as the federal safety watchdog requires. The Fridley, Minn.-based company instead shut down the review in 2008; company executives said the adverse events database compiled from the review was misfiled but eventually reported to the FDA in 2013, according to the newspaper. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 11, 2016 appeared first on MassDevice.