The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
Cardiovascular
Are Black patients not getting LVADs as quickly as white patients?
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 […]
St. Jude Medical founder and his Medical 21 raise $3M
Raising money for a startup company during a pandemic is no cakewalk, according to Manny Villafaña. But he did it. Medical 21, the latest venture for the founder of St. Jude Medical, has raised another $3 million in an equity offering, according to an SEC filing. The most recent round brings the Minneapolis-based start-up’s total funding […]
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 […]
B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study
B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a trial for the B. Braun SeQuent Please ReX. Bethlehem, Pa.–based BIS, a B. Braun affiliate, and Infraredx, a Nipro company, will work together to accelerate the FDA investigational device exemption (IDE) clinical trial for the SeQuent Please ReX drug-coated PTCA […]
FDA committee to examine safety of endovascular stent grafts
FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood […]
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 […]
