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MassDevice.com +5 | The top 5 medtech stories for November 30, 2016
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. Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patientâ...
Source: Mass Device - November 30, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patient’s blood and release blood-thinning drugs to prevent dangerous blood clots, or thrombosis. The team’s work was published in Advanced Materials.
When blood clots disrupt the flow of blood throughout the body, the result can cause pulmonary embolism, heart attack or stroke. Conventional treatment requires patients to regularly test their blood to ensure proper dosages of blood thinners such as Heparin. I
f a patient uses too small a dose, it may not prevent ...
Source: Mass Device - November 29, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Research & Development Source Type: news
St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today.
The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots.
The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. Source Type: news
Associations of Preimplant Red Blood Cell Distribution Width with Clinical Outcomes Among Individuals with Left Ventricular Assist Devices
In conclusion, higher preimplant RDW is independently associated with an increased risk of postimplant mortality and infection. Future studies are needed to understand the prognostic ability of RDW and to understand the biologic mechanism underlying this association.
Source: ASAIO Journal - November 1, 2016 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
Deaths prompt FDA warning on Baxter ’ s Vascu-Guard patch
The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occur...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International Source Type: news
Outcomes of Various Treatment Strategies for Patients with Continuous-Flow Ventricular Assist Device Thrombosis: A Retrospective Analysis
Pump thrombosis is associated with high morbidity and mortality in patients with a continuous-flow left ventricular assist device. Although it has been defined clearly, the diagnosis and treatment of this complication still remain controversial. Between 2010 and 2014, 163 consecutive patients (mean age: 50.7 ± 13 years, 84% males, median duration of support: 277 (2–1077) days) were implanted a continuous-flow left ventricular assist device. Prospectively collected data of all patients who had at least one pump thrombosis event have been analyzed, retrospectively. Twenty-one pump thrombosis events were observed in 15...
Source: ASAIO Journal - August 27, 2016 Category: Medical Equipment Tags: Adult Circulatory Support Source Type: research
Penumbra launches Ace68 Reperfusion thrombectomy catheter
Penumbra today announced the U.S. launch of the Ace68 Reperfusion thrombectomy catheter designed for extracting thrombus in acute ischemic stroke patients.
The company said the Ace68 catheter was engineered on an entirely new platform from hub to tip, which features coil winding geometry along 16 transitions to create a more optimal tracking profile.
“With the Ace68 Reperfusion Catheter, I can easily deliver full aspiration power to the occlusion. The Ace68’s large lumen increases the likelihood of capturing the clot fully within the catheter or the canister, potentially reducing the number of passes to achieve ...
Source: Mass Device - July 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Penumbra Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for May 26, 2016
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. Ortho Kinematics wins Health Canada nod for VMA system
Ortho Kinematics said today it won Health Canada authorization for its Vertebral Motion Analysis spinal imaging system.
The VMA system from Austin, Texas-based Ortho Kinema...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 5 Source Type: news
FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune.
The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper.
In a closer vote, the same panel ruled 11-5 that the device’s benefits o...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) St. Jude Medical Source Type: news
HRS 2016 roundup: Leadless pacers at the fore
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting.
St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events.
“We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemak...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Boston Scientific Cardiac Rhythm Management HRS 2016 Medtronic St. Jude Medical Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 13, 2016
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. Toshiba partners with UCI to study potential brain damage in HS football players
Toshiba said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football ...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale.
The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device,  a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with dr...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Food & Drug Administration (FDA) St. Jude Medical Source Type: news
Corvia Medical wins FDA nod for trial, inks exclusive buyout deal with strategic backer
Corvia Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its cardiac implant designed to treat diastolic heart failure and inked a deal with an unnamed strategic investor that includes an exclusive buyout option.
Corvia’s transcatheter InterAtrial shunt device is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria, according to Corvia’s website.
Tewksbury, Mass.-based Corvia said the 100-patient Reduce Lap-HF I study is a prospective, multicenter, randomized controlled trial. The primary ...
Source: Mass Device - March 7, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Mergers & Acquisitions Corvia Medical Source Type: news
HeartWare plunges on uncertainty around its next-gen MVAD pump
Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line.
Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombo...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat HeartWare International Inc. Source Type: news
Boston Scientific wins CE Mark for next-gen Watchman FLX
Boston Scientific (NYSE:BSX) said today it won CE Mark approval in the European Union for its Watchman FLX left atrial appendage closure device, and announced the device has been successfully implanted in its 1st set of patients.
The 1st Watchamn FLX devices were implanted last week by Dr. Horst Sievert of Frankfurt, Germany’s Sankt Katharinen Hospital, Dr. Vivek Reddy of Mt. Sinai Hospital in Prague’s Na Homolce Hospital and by Dr. Saibal Kar of Cedars-Sinai Heart Institute at Izola, Slovenia’s MC Medicor, Marlborough, Mass.-based Boston Scientific said.
“The Watchman Device is the most studied l...
Source: Mass Device - November 19, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Boston Scientific Source Type: news
