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Source: Mass Device
Management: Centers for Medicare and Medicaid Services (CMS)
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Total 8 results found since Jan 2013.
Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates.
The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so.
“In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news
Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday the Centers for Medicare and Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with the company’s Enroute transcarotid neuroprotection and stent system.
The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Sunnyvale, Calif.-based Silk Road Medical said.
The company said it...
Source: Mass Device - September 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Stents Vascular Centers for Medicare and Medicaid Services (CMS) Silk Road Medical Inc. Source Type: news
Cheetah Medical inks supply deal with Allina Health
Cheetah Medical said today it inked a supplier contract with non-for-profit healthcare system Allina Health.
Through the contract, Minnesota and western Wisconsin based Allina Health will gain access to Cheetah Medical’s hemodynamic monitoring solutions to help guide volume management decisions in septic patients, Cheetah Medical said.
“Intravenous fluid requirements vary significantly between patients based on underlying health conditions, and it can be a challenge to determine the right amount of fluid needed to properly maintain organ perfusion and optimize care. The Cheetah Medical technology has demonstra...
Source: Mass Device - July 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Cheetah Medical Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 21, 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. US gov’t delays CMS hospital rating system
The Obama Administration is holding off from publishing new hospital-quality ratings over concerns raised by healthcare providers and Congress over the methodology of the ratings sys...
Source: Mass Device - April 21, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 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
Analysts: Worst case unlikely in Medicare call on Boston Scientific’s Watchman anti-stroke device
The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts.
Boston Scientific shares took a hit earlier this month after the Centers for Medicare & Medicaid Services proposed to limit coverage for the Watchman device, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke. The FDA approved Watchman in March.
The federal health insurer proposed to limit coverage for Watchman to patients in approved clinical trials who can&#...
Source: Mass Device - November 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Stroke Source Type: news
MassDevice.com +3 | The top 3 medtech stories for August 17, 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. CooperSurgical pays $47m for IVF screener Reprogenetics
Cooper Cos. CooperSurgical subsidiary acquired in-vitro fertilization screening company Reprogenetics for nearly $47 million.
Livingston, N.J.-based Reprogenetics offers pre-implantation genetic screening and diagnosis for in vitro fertil...
Source: Mass Device - August 17, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
