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 of … [Read more...] about Boston Scientific warns on fragment embolization in some PolarSheath devices
Arya Sciences Acquisition Corp IV agreed to a business combination with Adagio Medical, taking the cardiac ablation company public. Upon the closing of the transaction, Adagio is set to become a subsidiary of Aja Holdco, still operating under its existing management team and under the name "Adagio Medical." Arya expects to list the combined … [Read more...] about Ablation tech developer Adagio Medical to go public in SPAC deal
Abbott (NYSE:ABT) announced today that an FDA advisory committee ruled that the benefits of its TriClip outweigh the risks in treating tricuspid regurgitation (TR). The Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA confirmed this with votes registering 13 to 1 in favor of TriClip’s benefits. Abbott … [Read more...] about FDA panel votes in favor of Abbott TriClip TEER system for treating tricuspid regurgitation
NEWS RELEASE: Freudenberg Medical establishes second production facility in Costa Rica $25 million investment to meet growing global demand for medical devices and precision components Expansion to quadruple manufacturing footprint for high volume minimally invasive catheters Creation of 600 new jobs, fostering growth for local … [Read more...] about Freudenberg Medical establishes second production facility in Costa Rica
Johnson & Johnson MedTech's Cerenovus today announced the launch of its next-generation CereGlide 71 intermediate catheter with TruCourse. The catheter's indication covers the revascularization of patients suffering from acute ischemic stroke. It joins the company's planned CereGlide family of catheters set to enhance the Cerenovus Stroke … [Read more...] about J&J’s Cerenovus launches next-gen stroke revascularization catheter
Innova Vascular today announced the successful early commercial use of its Laguna Thrombectomy System in California. The first physicians to use the system — Dr. Raj Khalsa and Dr. John Moriarty — reported positively after their initial cases. Khalsa touted the system's easy preparation, strong trackability in challenging anatomies and … [Read more...] about Innova Vascular has positive early commercial data for thrombectomy system
Following FDA approval on Jan. 31, Farapulse from Boston Scientific is now the second pulsed field ablation (PFA) system approved to treat atrial fibrillation (AFib) in the U.S.
Medtronic’s PulseSelect PFA System picked up the first FDA approval in December for the treatment of paroxysmal and persistent AFib.
Boston Scientific’s Farapulse, on … [Read more...] about Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system
Cortex announced today that it began its RESOLVE-AF trial evaluating its Ablamap system with the newly release Ablacath mapping technology. Launched by Ajax Health in December 2023, the company already offers the FDA-cleared Ablamap with electrographic flow (EGF). It seeks to pair the system with the newly released Ablacath mapping catheter to … [Read more...] about Cortex initiates trial of mapping tech for AFib ablation
Vena Medical this week announced that physicians at The Ottawa Hospital (TOH) were the first to use its stroke technology, the MicroAngioscope. Dr. Robert Fahed, an interventional neuroradiologist at TOH, used the MicroAngioscope to treat a patient who had repeated strokes. According to TOH, the device's advanced and high-resolution imaging … [Read more...] about Vena Medical achieves first-in-patient for its MicroAngioscope
AngioDynamics announced today that it received FDA 510(k) clearance for its Auryon XL catheter for use with the Auryon atherectomy system in treating peripheral arterial disease (PAD). The Auryon XP catheter is a 225 cm radial access catheter available in 0.9 mm and 1.5 mm diameters to expand treatment access points in atherectomy procedures in … [Read more...] about FDA clears AngioDynamics’ Auryon XL catheter