R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK pivotal trial for the next-generation bioresorbable scaffold. R3 Vascular makes […]
Clinical Trials
The biggest cardiovascular tech stories from TCT 2024
The 2024 edition of the Transcatheter Cardiovascular Therapeutics (TCT) conference once again highlighted significant innovations in cardiovascular care. This year’s event in Washington, D.C., featured company updates on all types of technologies, including heart valves, access and closure devices, drug-eluting implants, intravascular lithotripsy (IVL), renal denervation (RDN) and more. Some of the biggest names in […]
Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson MedTech today announced the completed enrollment in the pilot phase of a clinical trial for its Omnypulse pulsed field ablation platform. The OMNY-AF clinical trial evaluates the investigational platform for treating symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase enrollment of 30 patients. Johnson […]
Boston Scientific Acurate neo2 TAVR misses primary endpoint in IDE trial
Boston Scientific (NYSE:BSX) today announced that a study of its Acurate neo2 aortic valve system missed its primary endpoint. The ACURATE IDE study evaluated Acurate neo2, a transcatheter aortic valve replacement (TAVR) system, in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. Investigators presented […]
Edwards study shows superiority of Evoque tricuspid valve replacement
Edwards Lifesciences (NYSE:EW) today announced data highlighting the superiority of its Evoque system compared to medical therapy alone. The TRISCEND II evaluated the Evoque transcatheter tricuspid valve replacement (TTVR) system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization. It found that Evoque demonstrated superiority compared to OMT alone at the one-year […]
Inari Medical’s FlowTriever meets primary endpoint in pulmonary embolism trial
Inari Medical (Nasdaq:NARI) today announced positive results from its prospective PEERLESS trial for the FlowTriever system. The company designed its FlowTriever for device retrieval and aspiration. The system treats pulmonary embolism (PE). FlowTriever non-surgically removes clots from peripheral blood vessels. Its uses include treatment for PE and clots in transit in the right atrium. It received […]
Elixir Medical has positive data for drug-eluting bioadaptive implant
Elixir Medical announced positive data demonstrating the benefit of its DynamX coronary bioadaptor system in target lesion failure (TLF). Data highlighted the success of DynamX compared to Medtronic’s Resolute Onyx zotarolimus drug-eluting stent (DES). The study looked at complex patient populations within the INFINITY-SWEDEHEART randomized controlled trial. Data included an analysis of patients with acute […]
Vivasure reports positive PerQseal closure device study results
Vivasure Medical reported positive data from an FDA investigational device exemption (IDE) pivotal study evaluating its PerQseal closure device system. Initial results came from the PATCH pivotal study evaluating the safety and efficacy of PerQseal. Investigators presented findings at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite […]
Cardiawave has positive data for ultrasound tech that treats calcified aortic stenosis
Cardiawave said its device for the treatment of severe symptomatic calcific aortic stenosis (CAS) met the primary endpoint in a pivotal study. The investigational Valvosoft non-invasive ultrasound therapy (NIUT) device improved or stabilized heart failure symptoms for 80.5% of patients. It substantially improved hemodynamics and patient quality of life six months after treatment, according to […]
CytexOrtho gets FDA approval for first-in-human trial of absorbable hip implants
CytexOrtho today said it has approval from the FDA to start a Phase 1 clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients. CytexOrtho’s proprietary ReNew Hip Implant uses advanced 3D manufacturing techniques and polycaprolactone (PCL). The implant is designed to help hip disease patients who don’t yet need […]
Medtronic reports positive long-term renal denervation outcomes
Medtronic (NYSE:MDT) today announced new, long-term study data further supporting its Symplicity Spyral renal denervation (RDN) system. Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure. The RDN system holds approval for commercial use in more […]
