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Source: Mass Device
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Total 467 results found since Jan 2013.
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis.
Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail.
The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
HeartFlow wins Japanese reimbursement for FFRct analysis
HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis.
The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1.
“When a patient presents with symptoms suggesting CAD, we want to be able to quickly and effectively diagnose patients while reducing the need for unnecessary tests or invasive procedures. In clinical studies, we were able to see firstha...
Source: Mass Device - November 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Featured Imaging Software / IT HeartFlow Source Type: news
Corindus Shares rise on Q3 EPS beat
Shares in Corindus Vascular Robotics (OTC:CVRS) have risen over 10% today after the robotic surgical platform maker beat loss-per-share expectations on Wall Street with its third quarter earnings.
The Waltham, Mass.-based company posted losses of approximately $7.6 million, or 4¢ per share, on sales of approximately $3 million for the three months ended September 30, seeing losses shrink 3.3% while sales grew 22% compared with the same period during the previous year.
Losses per share were just ahead of the 5¢ consensus on Wall Street, where analysts expected to see sales of $3.2 million, which the company narrowly miss...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat Corindus Vascular Robotics Source Type: news
Abiomed joins Protembis $10m Series A
Protembis said today it closed a $10 million Series A round, joined by cardiovascular device-focused Abiomed (NSDQ:ABMD), to support its embolic cerebral protection device.
The round was joined by Abiomed, Aachen and Mönchengladbach GmbH’s Seed Fonds III and a number of family offices and angel investors, the Aachen, Germany-based company said.
“Patient safety should always be our top priority. We see great potential in Protembis’ technology to make TAVI neurologically safer and thus enable TAVI to be used in an even larger patient population,” Abiomed chief technology officer Dr. Thorsten Siess ...
Source: Mass Device - October 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Funding Roundup Neurological Wall Street Beat Abiomed protembis Source Type: news
Study: Delaying thombectomy, even for minutes, can lead to lifelong consequences
Delaying endovascular thrombectomy treatment for patients with acute ischemic stroke can take time off of patient’s lives and cost hospitals extra, according to a new study reported by Medscape.
Results from the study were presented by Dr. Wolfgang Kunz of Munich, Germany’s Ludwig Maximilian University during the 11th World Stroke Congress.
Every hour of delay within the first six resulted in, on average, a loss of approximately 0.6 quality-adjusted life years, or approximately 7.7 months of disability-free life, according to the report.
Beyond patient outcomes, every hour of delay also reduces the economic value o...
Source: Mass Device - October 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Source Type: news
FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation.
Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news
NYT Report: Apple Watch ‘ should not be considered a medical device ’
The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times.
The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives.
Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because somet...
Source: Mass Device - October 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics mHealth (Mobile Health) Apple Source Type: news
Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said.
The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news
FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection.
Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January.
A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said.
“We are thrilled to have achieved this milestone for the first of several devices Conteg...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news
Luciole Medical raised $5.5 million for blood oxygen probe
Swiss startup Luciole Medical announced today that it has closed a $5.5 million (CHF 5.3 million) Series A financing round to begin commercializing its minimally-invasive monitoring probe to measure blood oxygen levels in the brains of patients in intensive care units.
New investor SVC Ltd. (a subsidiary of Credit Suisse), led the round with Blue Ocean Ventures, Investiere and B-to-V as co-investors with significant support from existing shareholder Zürcher Kantonalbank. The company will also use some of the money to continue developing a non-invasive patch designed to measure oxygen saturation and blood flow in brain t...
Source: Mass Device - September 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Funding Roundup Patient Monitoring b-to-v blueoceanventures CreditSuisse investiere luciolemedical svcltd. Source Type: news
Boston Scientific touts Acurate Neo2 CE Mark study
Boston Scientific (NYSE:BSX) yesterday touted results from a European study of the Acurate Neo2 replacement heart valve it acquired along with Symetis last year.
Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said.
Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause mortality (the p...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news
Penumbra acquires 90% interest in MVI Health JV, launches thrombectomy devices
Penumbra (NYSE:PEN) said today it acquired 40% of the outstanding shares of virtual reality joint venture MVI Health from collaborator Sixense, boosting its interest to 90%, and said it launched the Penumbra Jet 7 and Jet D reperfusion catheters.
The joint venture intends to commercialize healthcare applications of virtual reality technology, Alameda, Calif.-based Penumbra said, though more information on the specifics of the technology has not yet emerged.
Penumbra said it paid $20 million to Sixense to acquire the additional 40% interest in a deal with contains an anti-dilution provision intended to allow Penumbra to is...
Source: Mass Device - September 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Vascular Penumbra Inc. Source Type: news
SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device.
In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction.
SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebr...
Source: Mass Device - August 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
Report: Amazon adds MGH cardiologist Majmudar | Personnel Moves – August 21, 2018
Amazon (NSDQ:AMZN) has picked up well-known cardiologist Dr. Maulik Majmudar for a new role within the company as it looks to continue its foray into healthcare, according to a recent CNBC report.
The announcement was made by Majmudar himself on Twitter, according to the report, though he did not state what his specific role within the company will be.
Prior to joining Amazon, Majmudar served as the associate director of Massachusetts General Hospital’s healthcare transformation lab and lectured at the Massachusetts Institute of Technology, according to the report.
Majmudar has advised tech companies in the past, accord...
Source: Mass Device - August 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Abbott Amazon BioCardia BioSig Technologies Endologix johnsonandjohnson Lantheus Lumendi Nuvasive personnel-moves Rox Medical royalphilips SetPoint Medical Steris Corp. Xtant Medical Source Type: news
