Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] 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 … [Read more...] about FDA approves Boston Scientific’s Agent drug coated balloon
Ablation tech developer Adagio Medical to go public in SPAC deal
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
FDA panel votes in favor of Abbott TriClip TEER system for treating tricuspid regurgitation
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
J&J’s Cerenovus launches next-gen stroke revascularization catheter
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 has positive early commercial data for thrombectomy system
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
Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system
Boston Scientific Chief Medical Officer Dr. Ken Stein explains how catheter design drives the Farapulse pulsed field ablation 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 Boston Scientific Chief Medical Officer Dr. Ken Stein explains how catheter design drives the Farapulse pulsed field ablation system.
Medtronic enrolls first patient in aneurysm repair trial
Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] announced today that it enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal … [Read more...] about Medtronic enrolls first patient in aneurysm repair trial
Cortex initiates trial of mapping tech for AFib ablation
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
FDA approves Gore low-profile balloon-expandable endoprosthesis
W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis. FDA approval builds on the company's proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range … [Read more...] about FDA approves Gore low-profile balloon-expandable endoprosthesis
Olympus completes acquisition of GI stent maker Taewoong Medical
Olympus announced today that it closed its acquisition of Taewoong Medical, a Korea-based medical device manufacturer. Taewoong Medical develops gastrointestinal (GI) metallic stents, among other offerings. Olympus announced its intent to acquire the company for $370 million in February 2023. The deal includes $255.5 million upfront, with up to … [Read more...] about Olympus completes acquisition of GI stent maker Taewoong Medical
