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Total 237 results found since Jan 2013.
Study: Catheter ablation better for AFib, heart failure than drugs
A meta-analysis of randomized controlled trials has found that catheter ablation was superior to conventional drug therapy alone for patients with atrial fibrillation (AFib) and heart failure.
AFib may lead to thromboembolic stroke, systemic embolism, and decompensated heart failure. Although catheter ablation is an established therapeutic strategy for AFib, guidelines recommend caution in certain patients, and the benefits and harms of catheter ablation versus drug therapy for Afib patients have not been firmly established.
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Source: Mass Device - December 26, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Catheters Research & Development icahnschoolofmedicine Source Type: news
InspireMD touts results of next-gen stroke prevention stent study
InspireMD (NYSE:NSPR) has released the results of a meta-analysis of four clinical studies involving dual-layered (DLS) and mesh-covered stents, including the company’s MicroNet-covered stent, the CGuard embolic prevention system.
The analysis concluded that carotid artery disease patients treated with mesh-covered stents experienced a 30-day minor stroke rate of 1.25%, lower than the 30-day minor stroke rates reported in other widely cited studies, such as CREST and ACT 1, for patients treated with both carotid endarterectomy and with those treated with conventional carotid stents. CREST and ACT 1 also involved lower...
Source: Mass Device - December 24, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Research & Development Stents InspireMD Terumo Source Type: news
J & J ’s Cerenovus launches global thrombectomy registry
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today that it launched a new registry aiming to collect and analyze stroke-inducing blood clots removed with the company’s Embotrap II revascularization device.
The Irvine, Calif.-based company touted the Excellent registry as the single largest global registry of its kind to date, looking to enroll up to 1,000 ischemic stroke patients across 50 locations in the U.S. and Europe. Investigators in the trial will collect and analyze clots removed to explore how different characteristics, including size, composition and density may affect outcomes, the company said.
I...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Featured Neurological cerenovus johnsonandjohnson Source Type: news
Corindus touts first-in-human coronary telerobotics study with CorPath system
Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.
The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab.
In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said.
The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Patel f...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Robotics Corindus Vascular Robotics Source Type: news
Conformal Medical raises $9m Series B for anti-stroke cardiac implant
Conformal Medical said today that it raised $9 million in a Series B round for the anti-stroke cardiac implant it’s developing.
Nashua, N.H.-based Conformal is working on a left atrial appendage seal to prevent stroke in atrial fibrillation patients. It’s designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia.
The funding round was led by Catalyst Health Ventures and included “a supportive group of Series A investors,” Conformal said.
“This financing will allow us to validate our novel sealing technology ...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Funding Roundup Wall Street Beat Conformal Medical Source Type: news
Nico raises $13m Series B for neurosurgery devices
Nico Corp. said today that it raised nearly $13 million in a Series B round from a group of existing backers for its line of neurosurgery devices.
Indianapolis-based Nico said the $12.5 million round is earmarked for new product development and commercialization, clinical and economic studies, growing its sales and clinical teams, and expanding its footprint in Europe.
“Our shareholders have again confirmed their commitment and confidence in the value and outcomes of Nico technologies and our ability to both grow and create new markets in neurosurgery,” president & CEO Jim Pearson said in prepared remarks....
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Surgical Wall Street Beat Nico Corp. 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
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
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
