Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system. Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut TAVI platform. It won U.S. FDA approval in 2019. The latest edition of the platform includes four […]
Replacement Heart Valves
CorWave touts ‘unprecedented’ study results
CorWave announced today that chronic in vivo studies of its implantable heart pump have proven “unprecedented” with strong results. Presenting at the annual meeting for the International Society for Heart and Lung Transplantation (ISHLT), CorWave touted the study as the first ever to demonstrate sensorless synchronization of a pericardial pump with the native heart for […]
Phoenix Cardiac wins CE mark for mitral regurgitation device
Phoenix Cardiac Devices announced that it received CE mark approval for its BACE device for treating functional mitral regurgitation (FMR). BACE (basal annuloplasty of the cardiac externally) is a novel modality for treating FMR and is touted as the only surgical device with long-term clinical data demonstrating significant benefit by addressing the root cause of […]
LivaNova rises on Street-beating Q1
LivaNova (NSDQ:LIVN) shares got a boost this morning on first-quarter results that beat the consensus forecast. LIVN shares were up 6.1% at $87.95 per share in early-morning trading today. The London-based company posted losses of -$29.7 million, or -61¢ per share, on sales of $247.6 million for the three months ended March 31, 2021, for […]
Edwards rises after hours on Street-beating Q1
Edwards Lifesciences (NYSE:EW) shares ticked up after hours today on first-quarter results that topped the consensus forecast. The Irvine, Calif.–based company posted profits of $338.2 million, or 54¢ per share, on sales of $1.22 billion for the three months ended March 31, 2021, for an 8.9% bottom-line gain on sales growth of 7.8%. Adjusted to […]
Abbott stock down on mixed bag Q1
Abbott (NYSE:ABT) shares are down today on first-quarter results that were mixed compared to the consensus forecast. The Abbott Park, Ill.–based company posted profits of $1.8 billion, or $1 per share, on sales of $10.5 billion for the three months ended March 31, 2021, more than doubling its bottom-line on sales growth of 35.3%. Adjusted […]
Abbott’s MitraClip doesn’t hinder oxygen levels, study shows
Researchers at Penn Medicine revealed results of a retrospective study that found no negative effects with the Abbott (NYSE:ABT) MitraClip. The study found no negative effect with having a slightly smaller mitral valve opening as long as there was good reduction of the mitral regurgitation, according to a news release. MitraClip, while used to help […]
Abbott wins CE mark for next-generation TriClip
Abbott (NYSE:ABT) announced today that it received CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system. The company touts the TriClip as a first-of-its-kind, minimally invasive tricuspid heart valve repair device for treating tricuspid regurgitation (TR), according to a news release. Abbott Park, Ill.–based Abbott’s clip-based therapy is a non-surgical heart valve […]
Boston Scientific touts results of Watchman study
Boston Scientific (NYSE:BSX) is touting 12-month results from a trial assessing its next-generation Watchman left atrial appendage closure (LAAC) device. Results from the Pinnacle FLX trial were published in Circulation and highlighted the safety and efficacy of Watchman for stroke prevention in patients with non-valvular atrial fibrillation. The 400-patient study observed Watchman FLX as an alternative […]
8 medical device companies that beat the COVID-19 pandemic and prospered
Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread. Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was […]
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device […]
