CardioFocus announced the completion of successful clinical cases with its QuickShot Nav large-area focal pulsed field ablation (PFA) catheter. Dr. Ante Anić performed the cases for the treatment of persistent AFib at KBC Split in Split, Croatia. They came as part of the Quick AF study evaluating the investigational PFA catheter. Anić serves as principal […]
Catheters
Terumo Neuro wins FDA nod for first dual-layer carotid stent
Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment. The stent system […]
Imperative Care to kick off new trial of Zoom stroke treatment
Imperative Care announced today that it intends to fund a trial comparing its Zoom stroke system plus best medical treatment to treatment alone. Campbell, California–based Imperative Care designed Zoom for fast and effective clot removal from access through reperfusion. It treats patients with acute ischemic stroke, enabling smooth tracking through challenging vasculature. The study examines […]
Spectrum Vascular bolsters executive team with new CEO, CCO
Spectrum Vascular announced today that it added to its executive team with the appointment of Ken Miller as CEO and Doug Shook as CCO. The company said its leadership appointments help advance its mission to deliver improved patient outcomes and scale impact. They build upon recent momentum, according to a news release, following a strategic […]
Cagent Vascular initiates balloon angioplasty study
Cagent Vascular announced that it enrolled the first patient in a study comparing its Serranator system to plain old balloon angioplasty (POBA). The prospective, randomized (2:1 treatment to control) dual-center study plans to enroll up to 60 subjects. Investigators intend to use optical coherence tomography (OCT) imaging to demonstrate the mechanism of action (MOA) of […]
Merit Medical launches aortic access delivery system
Merit Medical Systems (Nasdaq:MMSI) announced that it launched the Ventrax delivery system for cardiac interventions. South Jordan, Utah–based Merit adds the latest delivery system to its growing electrophysiology (EP) and cardiac rhythm management (CRM) portfolio. It joins solutions such as HeartSpan, Worley, Prelude Snap and SafeGuard Focus. The company designed Ventrax to facilitate the placement […]
Elixir Medical launches IVL system in Europe
Elixir Medical announced today that it received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system. The Milpitas, California–based company kicked off its commercial launch for the IVL system in Europe following receipt of CE mark. Dr. Stefano Galli (Centro Cardiologico Monzino in Milan), Dr. Eric Van Belle (Lille University Hospital, Lille, […]
J&J’s Shockwave enrolls first patient in novel forward IVL study
Johnson & Johnson MedTech‘s Shockwave Medical announced today that it initiated a study evaluating its Javelin coronary IVL catheter. FORWARD CAD, an FDA investigational device exemption (IDE) study, evaluates the safety and efficacy of the company’s latest intravascular lithotripsy (IVL) catheter. It aims to treat calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting. […]
Anaconda Biomed enrolls first patient in study of funnel catheter for treating stroke
Anaconda Biomed announced the enrollment and treatment of the first U.S. patient in a clinical trial of its ANA Funnel Catheter. Dr. Shahram Majidi performed the first treatment in the ATHENA trial at Mount Sinai in New York. The 327-patient study evaluates the safety and effectiveness of the proprietary funnel catheter. Anaconda designed the device […]
Court revives renal denervation patent battle between ReCor, Medtronic
A U.S. appeals court has vacated a decision from the U.S. Patent and Trademark Office (USPTO), reviving a spat between Recor Medical and Medtronic. The patent battle centers around renal denervation (RDN) technology for treating hypertension. Recor and Medtronic are the two leaders in this space, with Recor Medical receiving an FDA nod for its Paradise […]
Surmodics launches Pounce XL thrombectomy system
Surmodics (Nasdaq:SRDX) announced today that it commercially launched the Pounce XL thrombectomy system for clot removal. Pounce XL joins the larger suite of Pounce thrombectomy systems. They offer rapid endovascular removal of acute or chronic clot from peripheral arteries. Eden Prairie, Minnesota-based Surmodics designed Pounce to enable physicians to rapidly restore blood flow regardless of […]
