The FDA today declared the recall of a Boston Scientific subcutaneous electrode used in implantable cardioverter defibrillators (ICDs) as Class 1, the most serious. The company warned physicians in December 2020 that approximately 47,000 Emblem S-ICD1 subcutaneous electrodes (model 3501) may fracture. Boston Scientific said at the time that it had received 27 reports of […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
BioSig, Mayo Clinic announce AI development partnership
BioSig Technologies (NSDQ:BSGM) will work with the Mayo Foundation for Medical Education and Research to develop next-gen, AI-powered software for its Pure EP system, which is meant to take electrophysiology to the next level. The Mayo Clinic has already been an important investor and development partner for the Westport, Conn.–based company. BioSig signed a 10-year collaboration […]
FDA: Penumbra recall of some Jet 7 catheters is serious
A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said. The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related […]
Abiomed touts results of Impella study
Abiomed (NSDQ:ABMD) recently announced positive results from a study of its Impella 5.5 heart pump with SmartAssist. Danvers, Mass.-based Abiomed’s study across 16 U.S. and German locations found a 79% survival rate at explant in 356 patients treated with Impella 5.5 with SmartAssist. A majority of surviving patients recovered native heart function without needing further mechanical […]
Edwards touts 5-year aortic valve trial results
Edwards Lifesciences (NYSE:EW) announced data showing favorable safety and hemodynamic performance from its Resilia tissue platform. Data from Edwards’ Commence clinical trial demonstrated that its bioprosthetic surgical aortic valve with the novel Resilia tissue aortic valve platform produced favorable results across a median of five years follow-up, according to a news release. Commence is a prospective, […]
Medtronic wins FDA approval for DiamondTemp ablation system
Medtronic (NYSE:MDT) announced today that it received FDA approval for its DiamondTemp ablation (DTA) system for treating Afib. Fridley, Minn.-based Medtronic’s DiamondTemp ablation system treats patients with recurrent, symptomatic paroxysmal Afib who have been unresponsive to drug therapy. The medtech giant touts DiamondTemp as the first FDA-approved, temperature-controlled, irrigated radiofrequency ablation system with diamonds currently available […]
Jefferies remains optimistic about Abiomed
Analysts are expressing optimism over Abiomed (NSDQ:ABMD) after the company’s third-quarter results saw its stock soar yesterday. Upon releasing the quarterly report, Abiomed’s stock rose 12.4% at $369.45 in the early morning yesterday. The stock price rose as high as $387.23 yesterday but has since dropped to $341.42 at midday today. Jefferies analysts released a report […]
Ancora Heart says enrollment has started for AccuCinch pivotal trial
Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial. AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support […]
Abiomed skyrockets on Street-beating Q3
Abiomed (NSDQ:ABMD) shares shot up this morning on third-quarter results that topped the consensus forecast. Shares of ABMD were up 12.4% at $369.45 per share in early-morning trading today. The Danvers, Mass.-based oxygenation device maker posted profits of $61.9 million, or $1.35 per share, on sales of $231.7 million for the three months ended Dec. 31, […]
Edwards Lifesciences misses on earnings in Q4
Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings this evening that missed the consensus forecast on Wall Street, though the company met revenue expectations. The Irvine, Calif.–based cardio device company reported profits of $309.5 million, or 49¢ per share, on sales of $1.19 billion for the three months ended Dec. 31, 2020, for a bottom-line gain of 10.5% […]
Boston Scientific to acquire Preventice Solutions
Boston Scientific (NYSE:BSX) announced today that it entered into a definitive agreement to acquire Preventice Solutions. Minneapolis-based Preventice designs mobile health solutions and remote monitoring services for patients with cardiac arrhythmias. Its wearables include the PatientCare platform and BodyGuardian family of monitors. Preventice’s BodyGuardian monitors use a fully-integrated, cloud-based platform for clinical technicians and AI algorithms […]