Orchestra BioMed today announced a slew of agreements, including a strategic collaboration with Medtronic (NYSE:MDT). The global strategic collaboration will progress the development of Orchestra BioMed’s BackBeat Cardiac Neuromodulation Therapy (CNT) as a potential treatment for hypertension in patients who are indicated for a cardiac pacemaker. Additionally, Orchestra BioMed closed a $110 million Series D […]
Cardiac Implants
Another Medtronic HVAD recall is serious
A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this […]
Corvia Medical closes $54M financing to support atrial shunt
Corvia Medical announced today that it closed a $54 million equity financing from its existing investor syndicate. Tewksbury, Massachusetts–based Corvia Medical earmarked the funds to support a confirmatory trial to build upon data and learnings from the clinical trial of its Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced HFmrEF […]
Study supports Boston Scientific’s Acurate neo2 aortic valve system
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 […]
FDA designates new Medtronic HVAD pump implant recall as Class I
Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death. The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 […]
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 […]
Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
Data presented today at the EuroPCR 2022 event supported the use of the Medtronic (NYSE:MDT) Resolute Onyx drug-eluting stent. University of Padua Medical School Head of Interventional Cardiology Dr. Giuseppe Tarantini presented late-breaking clinical trial results from the investigator-initiated, Medtronic-funded ROLEX (Revascularization Of LEft Main With Resolute onyX) registry. ROLEX, the largest real-world, multicenter prospective study, observed […]
FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases. Get […]
