Researchers from the University of Missouri conducted a study that found disparities in treating Black and white patients with advanced heart failure. According to a news release, the study found that Black patients with advanced heart failure were more likely to receive a left ventricular assist device (LVAD) — a pump implanted into the chest […]
Cardiac Implants
FDA advisory committee positive about TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System. The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable […]
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 […]
Abbott Xience stent gains expanded CE mark
Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news […]
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 […]
Federal judge won’t let Boston Scientific avoid Watchman lawsuit
A federal judge in western North Carolina has declined to dismiss a wrongful death lawsuit against Boston Scientific (NYSE:BSX) over its Watchman stroke prevention device. Boston Scientific had sought to have the suit — brought by the Jean Penland estate — dismissed based on the Supreme Court’s decade-old Riegel v. Medtronic decision. The Riegel ruling […]
Abbott halts heart pump trial
Abbott (NYSE:ABT) has halted a clinical trial comparing its HeartMate percutaneous heart pump (PHP) ventricular assist device with the Abiomed (NSDQ:ABMD) Impella heart pumps. The Abbott Park, Ill.-based company suspended enrollment in the Shield II investigational device exemption study after a report of decreased impeller speed at the end of a procedure. The HeartMate PHP system […]
10 Minnesota medtech startups you need to know
Medical device startups can use all the help they can get, including from government-sponsored investment funds. In Minnesota, one of the nation’s top three medtech hubs, the state Department of Employment and Economic Development (DEED) has distributed $1.6 million per year since 2019 in innovation grants to tech startups — many of them in the […]
2 deaths reported in Medtronic HeartWare recall
Medtronic (NYSE:MDT) is recalling its HeartWare HVAD pump implant kit because the device may fail to start, restart, or have a delay in restarting after the pump was stopped, the FDA announced today. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations, […]
LivaNova slides despite Street-beating Q4
LivaNova (NSDQ:LIVN) shares took a dip this morning despite fourth-quarter results that topped the consensus forecast. The London-based company posted losses of $279.8 million, or -$5.75 per share, on sales of $269.6 million for the three months ended Dec. 31, 2020, for a 95.4% bottom-line slide deeper into the red on a sales decline of -6.3%. […]
