Autonomix Medical announced today that it completed the first three patient procedures in a proof-of-concept trial of its ablation technology. The Woodlands, Texas-based Autonomix designed its transvascular radiofrequency (RF) ablation technology to treat pancreatic cancer pain. Current approaches to treat this pain include opioids or ethanol injections. However, Autonomix says those approaches may only provide […]
Catheters
Inari Medical has positive ClotTriever data
Inari Medical announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system. Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum. Results represent the largest prospective, multi-center, two-year dataset in deep-vein thrombosis (DVT) since the ATTRACT trial, Inari said in a […]
Boston Scientific has positive Agent DCB study results
Boston Scientific reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to […]
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, […]
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary hypertension with associated heart failure. Paris-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina. Dr. Marat Fudim and […]
Stereotaxis submits Magic ablation catheter for U.S., European approval
Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval. The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. According to a news release, the […]
FDA approves Boston Scientific’s Agent drug-coated balloon
Boston Scientific announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts–based Boston Scientific plans a U.S. launch for Agent in […]
J&J Biosense Webster’s Varipulse PFA system wins CE mark
J&J MedTech’s Biosense Webster unit announced today that it won CE mark approval for its Varipulse pulsed field ablation (PFA) platform. European officials approved Varipulse for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto […]
Argá Medtech closes oversubscribed Series B funding for pulsed field ablation tech
Argá Medtech today announced it closed a €54 million oversubscribed Series B funding round to support its pulsed field ablation technology. The Lausanne, Switzerland-based company develops the Coherent Sine-Burst Electroporation pulsed field ablation system for treating cardiac arrhythmias, including atrial fibrillation. Argá’s latest financing will allow the company to advance the development of its CSE […]
Boston Scientific warns on fragment embolization in some PolarSheath devices
Boston Scientific has issued an urgent field safety notice for some of its PolarSheath steerable sheaths due to the risk of embolization. The company is removing specific batches of PolarSheath steerable sheaths due to a tooling error in manufacturing, which may have caused delimitation of the inner lumen of the sheath shaft in a subset […]
AngioDynamics sells PICC and Midline portfolios for $45M, discontinues sales of radiofrequency ablation devices
AngioDynamics recently announced the sale of its PICC and Midline product portfolios to Spectrum Vascular for up to $45 million in cash. The company PICC, Midline and tip location products contributed approximately $43.5 million in annual sales during AngioDynamics’ fiscal year 2023. The transaction consists of $34.5 million paid at closing, an earnout related to […]