The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD). This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may […]
Structural Heart
Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system
Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant […]
FDA labels Boston Scientific ICD electrode recall serious
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 […]
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, […]
Abbott’s MitraClip receives boost as CMS expands coverage for TMVR
Abbott (NYSE:ABT) announced today that CMS revised its coverage for TMVR, opening up new possibilities for its MitraClip device. The CMS National Coverage Determination (NCD) expands coverage for transcatheter mitral valve repair (TMVR) to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure. According to an Abbott news release, the CMS decision […]
These medtech stocks performed the best in 2020
While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while […]
