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Total 34 results found since Jan 2013.
FDA green-lights Aegis Medical trial for Sierra ligation device
This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release.
“For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device,...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Aegis Medical Innovation Source Type: news
TCT 2016: Stents, stents, stents on Day 1
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.
Stents took center stage Day1, with a raft of studies covering the latest on the bioresorbable front.
Stents equivalent to CABG
Drug-eluting stents are as effect as coronary artery bypass grafts in treating patients with blocked left main coronary arteries, according to a study that compared Abbott‘s (NYSE:ABT) Xience DES with CABG i...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Stents TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
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
Study: TAVR safer than surgery in low-risk heart failure patients
Transcatheter aortic valve replacement procedures with self-expanding systems resulted in higher survival rates for patients at lower risk for surgery when compared to surgical aortic valve replacement procedures, according to a study released this month.
Results from the study, which compared Medtronic‘s (NYSE:MDT) self-expanding CoreValve TAVR system, were published in JAMA Cardiology this month.
The retrospective analysis compared patients from the CoreValve U.S. pivotal high-risk trial of patients with STS PROM scores of 7% or less who either underwent TAVR procedures or surgery, with a median STS Prom score of...
Source: Mass Device - August 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Medtronic Source Type: news
Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from the FDA last June for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts.
Data from the studies was published in the journals Neurosurgery and Operative Neurosurgery, the Indianapolis-based c...
Source: Mass Device - June 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Surgical Nico Corp. Source Type: news
Chinese dev LifeTech wins CE Mark for LAA closure device
Chinese developer LifeTech Scientific said today it won CE Mark approval in the European Union for its LAmbre left atrial appendage closure system, touting it as the 1st Chinese-developed LAA closure system to receive such approval.
The LAmbre system is designed for the closure of the LAA percutaneously through a small 8 to 10 Fr sheath, and consists of a distal umbrella and a proximal cover disc connected by a short sleeve, LifeTech said. The device is fully recapturable and repositionable, the company added.
“We are proud of the CE mark of the first LAA closure system from China and confident that our LAmbre LAA ...
Source: Mass Device - June 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance LifeTech Scientific Corp. Source Type: news
Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients.
Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients).
Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts.
Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke.
The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement Source Type: news
MassDevice.com +3 | The top 3 medtech stories for November 24, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication.
Bedford, Mass.-based Ocular Th...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer.
Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset of the patients who currently would be eligible for the device under the FDA-approved label,” or patients at high risk for stroke and bleeding and/or contraindicated to long-term warfarin use.
“Whi...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Source Type: news
Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device
Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday.
Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approv...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news
Boston Scientific touts Watchman study data
Boston Scientific (NYSE:BSX) yesterday presented data on its Watchman left atrial appendage occlusion device. The data was presented at the annual American Heart Association’s Scientific Sessions in Orlando, Fla.
The data comes from the Ewolution registry, the 1st real-world study of the Marlborough, Mass.-based company’s Watchman device.
The patient population of the study was the ‘highest risk patient population ever studied in a Watchman trial,” Boston Scientific said. A total 61.8% of the patient population were deemed contraindicated for oral anticoagulants.
The study reported the lowest peri-...
Source: Mass Device - November 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Boston Scientific Source Type: news
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
Early thrombectomy’s promise Totaled?
The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 Source Type: news
Thoratec HeartMate 3 CE trial meets primary endpoint
Thoratec (NSDQ:THOR) said today the CE Mark trial of its HeartMate 3 left ventricular assist device has met its primary endpoint and reported a 92% rate of survival at 6 months. Data from the trial was presented at the Heart Failure Society of America’s annual meeting in Washington D.C.
The HeartMate 3 is a centrifugal-flow chronic left ventricular assist system which uses magnetically levitated technology and a reduced size for easier placement, the Pleasanton, Calif.-company said.
“The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material i...
Source: Mass Device - September 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Thoratec Corp. Source Type: news
CerebroTech wins CE Mark for non-invasive brain monitor
Non-invasive brain monitor company Cerebrotech Medical Systems said it won CE Mark approval for its intracranial fluids monitor.
The technology, developed at the University of California at Berkeley, detects changes in electrical proprties of tissues as a result of small changes in fluid, according to the Pleasanton, Calif.-based company’s site.
“We are very pleased to receive this validation of our technology. With clearance to commercialize in Europe, the company is moving into the next stage of its mission to significantly improve the clinical pathway and standard of care for patients with brain injuries,” sai...
Source: Mass Device - August 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics Imaging Regulatory/Compliance Cerebrotech Medical Systems Source Type: news
