Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand TAVR II pivotal trial. Expand TAVR II will evaluate the self-expanding, supra-annular Evolut transcatheter aortic valve replacement (TAVR) platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for TAVR. According to a news release, […]
Structural Heart
Late-breaking data supports use of Boston Scientific’s S-ICD, Watchman FLX devices
Late-breaking data highlighted the effectiveness of Boston Scientific’s (NYSE:BSX) S-ICD technology and Watchman FLX device. Multiple trials, for which data was presented at the Heart Rhythm Society (HRS) Heart Rhythm 2022 conference, backed Marlborough, Massachusetts-based Boston Scientific’s subcutaneous implantable cardiac defibrillators (S-ICD) against transvenous ICDs (TV-ICD) — and the Watchman FLX left atrial appendage closure […]
Medtronic investigates HVAD pump welds after patient deaths
Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one year after halting sales and new implantations of the device. Fridley, Minnesota-based Medtronic said it received three complaints of suspected pump thrombosis in patients. Two of the patients died after their heart pumps were exchanged. Medtronic found a malfunction when inspecting […]
Abbott announces U.S. launch of Amplatzer steerable delivery sheath for Amulet device
Abbott (NYSE:ABT) announced today that it made the Amplatzer steerable delivery sheath commercially available in the U.S. The Amplatzer steerable delivery sheath works with the Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with AFib who are at risk of ischemic stroke According to a news release, the Amulet with dual-seal technology offers […]
Edwards Lifesciences shares fall on Street-beating Q1 results
Edwards Lifesciences (NYSE: EW) posted first-quarter results today that beat the consensus forecast on Wall Street. It also reaffirmed its outlook for the rest of the year, with CEO Michael Mussallem saying, “We are hopeful the worst of the pandemic is behind us.” The Irvine, California–based cardio device company reported profits of $373.6 million, or […]
18 of the world’s most innovative medical technologies
Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards. The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that have received a Prix Galien award […]
Recall of Medtronic’s Harmony delivery catheter is Class I
The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system. Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a delivery catheter (the […]
FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices
Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices. Lake Oswego, Oregon-based Biotronik designed its Renamic Neo programmer for implanted devices, including ICDs, pacemakers and implantable cardiac monitors. According to a news release, Renamic Neo offers LifeSupport for clinicians to share the programmer screen with or grant […]
Abiomed announces first Impella BTR heart pump implant
Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study. The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago. Impella BTR is a forward flow heart pump implanted […]
Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics
It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for […]
Where are LVADs headed in the future?
Abbott (NYSE:ABT) became the dominant provider of left ventricular assist devices (LVADs) after Medtronic’s decision last year to leave the market. The Abbott HeartMate 3‘s advantages include its Full MagLev flow technology — which involves a free-floating magnetically levitated rotor that prevents surface-to-surface contact that could cause blood trauma. In addition, system batteries provide up […]
