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Stroke

Analysts: Worst case unlikely in Medicare call on Boston Scientific’s Watchman anti-stroke device

November 23, 2015 By Brad Perriello

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 […]

Filed Under: Cardiac Implants, Wall Street Beat Tagged With: Boston Scientific, Centers for Medicare and Medicaid Services (CMS), Reimbursement, Stroke

Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device

November 12, 2015 By Brad Perriello

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Recalls Tagged With: Boston Scientific, Cardiac Rhythm Management, Stroke

Silk Road Medical raises $57 million

October 20, 2015 By Brad Perriello

Silk Road Medical today said it reeled in a $57 million equity-and-debt round from a group of new and existing backers. Sunnyvale, Calif.-based Silk Road, which makes the Enroute transcarotid artery stent and neuroprotection system, said CRG led the debt round and participated in the equity portion, joined by prior investors Warburg Pincus and The Vertical Group. “The […]

Filed Under: Funding Roundup, Stents, Vascular Tagged With: Silk Road Medical Inc., Stroke

Medtronic launches Arc stroke catheter in the U.S.

September 17, 2015 By Brad Perriello

Medtronic (NYSE:MDT) said today that it expanded its thrombectomy offering in the U.S. with the Arc catheter, designed for use with its Solitaire stent retriever in treating acute ischemic stroke. Fridley, Minn.-based Medtronic said the Arc catheter won 510(k) clearance from the FDA in July. “The Arc support catheter will complement our Solitaire stent retriever and […]

Filed Under: Catheters, Neurological Tagged With: Medtronic, Stroke

Penumbra files for $115m IPO

August 17, 2015 By Brad Perriello

Penumbra, fresh off its latest entry into the peripheral vascular market, last week registered for an initial public offering worth $115 million. Alameda, Calif.-based Penumbra also makes devices for treating neurovascular conditions including hemorrhagic and ischemic stroke. The company reported sales of $125.5 million last year, up 41.3% over 2013. Founded in 2004, Penumbra said it employs […]

Filed Under: Funding Roundup, Initial Public Offering (IPO), Neurological Tagged With: Penumbra Inc., Peripheral, Stroke

FDA warns on SentreHeart’s Lariat anti-stroke device

July 13, 2015 By Brad Perriello

The FDA today warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device made by SentreHeart, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths. The Lariat device is designed to close off the heart’s left atrial appendage, to prevent blood clots […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: SentreHeart, Stroke

New Watchman study reports positive data

June 16, 2015 By Fink Densford

New data from a study of Boston Scientific (NYSE:BSX)’s Watchman left atrial appendage closure device reports positive results in a study comparing it to warfarin, an anticoagulant drug treatment, in patients with nonvalvular atrial fibrillation. The 2,406-patient study, published in the Journal of the American College of Cardiology, reported a lower rate of hemorrhagic strokes, unexplained and cardiovascular […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials Tagged With: Boston Scientific, Clinical Trials, Stroke

Penumbra wins FDA nod for Ace64 thrombectomy device

May 27, 2015 By Fink Densford Leave a Comment

Penumbra wins FDA nod on Ace64

Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the Mr. Clean trial and additional randomized controlled stroke trials.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Penumbra Inc., Stroke

HRS 2015: Boston Scientific touts cost-saving data for Watchman

May 14, 2015 By Brad Perriello Leave a Comment

HRS 2015: Boston Scientific touts cost-saving data for Watchman

Filed Under: Cardiac Implants, News Well Tagged With: Boston Scientific, Clinical Trials, Stroke

HRS 2015: SentreHeart’s Lariat device leads to 20% leak rate

May 14, 2015 By Fink Densford Leave a Comment

HRS 2015: SentreHeart's Lariat device leads to leaks

A study by researchers from the Texas Cardiac Arrhythmia Institute revealed a 20% rate of atrial leak development after 1 year in patients treated with SentreHeart’s Lariat ligation device.

Filed Under: Cardiac Implants, News Well Tagged With: HRS 2015, SentreHeart, Stroke

Boston Scientific’s Mahoney is bullish on Watchman

April 29, 2015 By MassDevice Leave a Comment

Boston Scientific's Mahoney is bullish on Watchman

Filed Under: News Well, Wall Street Beat Tagged With: Boston Scientific, Stroke

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