New registry data demonstrates positive hemodynamic performance and clinical outcomes with the Boston Scientific (NYSE:BSX) Acurate neo2 TAVI system. Dr. Andrea Scotti of the Montefiore Medical Center (New York) presented data on the current-generation aortic valve system at TVT: The Structural Heart Summit. It was simultaneously published in EuroIntervention. In an investigator-driven study, retrospective registry […]
Replacement Heart Valves
Abbott presents positive data on MitraClip, TriClip heart implants
Abbott (NYSE:ABT) today announced late-breaking data supporting its MitraClip and TriClip structural heart solutions. Data for the MitraClip transcatheter edge-to-edge repair (TEER) device and the TriClip minimally invasive tricuspid heart valve repair device were presented at TVT: The Structural Heart Summit, the annual meeting from the Cardiovascular Research Foundation in Chicago. The company said in […]
Boston Scientific’s Acurate Neo2 valve performs well in studies
Boston Scientific (NYSE:BSX) announced positive outcomes from studies of its Acurate Neo2 aortic valve system. Initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves demonstrated that commissural alignment can be […]
Abbott reports positive data on heart valve therapies
Abbott (NYSE:ABT) today announced clinical study data supporting its TriClip and Navitor heart valve treatment technologies. Data for the TriClip minimally invasive tricuspid heart valve repair device and Navitor next-generation transcatheter aortic valve implantation (TAVI) system were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR). Real-world outcomes from the […]
Study shows strong performance, improved outcomes with Medtronic Evolut TAVR
Medtronic (NYSE:MDT) today announced positive results from a study of its Evolut transcatheter aortic valve replacement (TAVR) system. The Optimize PRO clinical study evaluated the self-expanding, supra-annular Evolut PRO and PRO+ TAVR platforms. Medtronic’s CoreValve Evolut R, CorValve Evolut PRO and Evolut Pro+ systems are indicated for the relief of aortic stenosis in patients with […]
Vivasure raises $23M initial Series D tranche; could reach up to $54M
Vivasure Medical announced today that it closed the first tranche — worth $23 million — of its Series D financing round. Galway, Ireland-based Vivasure’s $23 million (€22 million) fundraising tranche could make up a chunk of the Series D that could reach up to $54 million (€52 million) in total. According to a news release, […]
Medtronic enrolls first patient in trial of Evolut TAVR system in patients with aortic stenosis
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, […]
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 […]
Studies show that iRhythm’s Zio detects AFib early, prevents hospital admissions
iRhythm Technologies (Nasdaq:IRTC) announced results of multiple studies supporting the use of its Zio technology in detecting AFib. San Francisco-based iRhythm presented the results of three clinical research studies at The American College of Cardiology’s 71st Annual Scientific Session & Expo. According to a news release, the studies further validate Zio as an option for […]
