The Teleflex (NYSE: TFX) Freesolve RMS (resorbable magnesium scaffold) has won FDA Breakthrough Device designation for percutaneous coronary intervention (PCI). "Freesolve RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to … [Read more...] about Teleflex wins Breakthrough Device designation for Freesolve resorbable scaffold
Product Development
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon
Abbott earns FDA approval for new dual-energy ablation catheter
Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
FastWave Medical earns FDA IDE approval for next-gen IVL system
FastWave Medical earned FDA investigational device exemption (IDE) approval for its next-generation intravascular lithotripsy (IVL) technology, the company announced today. The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease. "Reaching IDE approval takes a … [Read more...] about FastWave Medical earns FDA IDE approval for next-gen IVL system
First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Flow Medical is developing a thrombolysis catheter to improve the treatment of blood clots in pulmonary embolism patients. The Chicago-based startup designed its minimally invasive system with a novel nitinol scaffold that perforates blood clots and infuses them with tissue plasminogen activator (TPA), a thrombolytic drug commonly referred to as … [Read more...] about First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
How Medtronic designed the PulseSelect pulsed field ablation system for AFib
Medtronic‘s PulseSelect became the first pulsed field ablation (PFA) system to win FDA approval for treating atrial fibrillation (AFib) in December 2023. The world’s largest medical device manufacturer achieved that milestone about 15 years after one of its engineers, Mark Stewart, coined the term “pulsed field ablation” in a research paper … [Read more...] about How Medtronic designed the PulseSelect pulsed field ablation system for AFib
This medtech developer is throwing everything at clots
Retriever Medical is developing a thrombectomy system with a four-front approach for treating blood clots. The Las Vegas-based startup calls its technology VORS AMD, for vascular occlusion removal system with aspiration, mechanical and drug delivery. The approach combines nitinol baskets for mechanical thrombectomy with aspiration, clot-busting … [Read more...] about This medtech developer is throwing everything at clots
How Abbott created its next-gen RF ablation system
For Abbott, combining two innovations into one AFib-treating system required manufacturing fine-tuning. The project’s R&D director explains. Pulsed field ablation (PFA) has generated a great deal of buzz for its potential to reduce complications in procedures for treating atrial fibrillation (AFib). But even as Abbott is developing its Volt … [Read more...] about How Abbott created its next-gen RF ablation system
Microbot Medical expands U.S. operations to prep for first in-human clinical study
Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its … [Read more...] about Microbot Medical expands U.S. operations to prep for first in-human clinical study
VVT Medical announces first commercial ScleroSafe case in U.S.
VVT Medical recently announced the successful completion of the first commercial U.S. varicose vein treatment using its ScleroSafe platform. Dr. Steve Elias performed the procedure at the Center for Vein Disease, part of the Englewood Health Network in Englewood, New Jersey. “The Sclerosafe procedure takes less than 30 minutes, requires only … [Read more...] about VVT Medical announces first commercial ScleroSafe case in U.S.
