Medtronic (NYSE: MDT)announced today that it entered into an exclusive U.S. distribution agreement with Contego Medical. Under the agreement, Medtronic serves as the sole U.S. distributor for Contego's portfolio of commercially available products. Raleigh, North Carolina-based Contego offers products that provide revascularization treatment for … [Read more...] about Medtronic inks stent distro deal with Contego with option to buy
Balloons
Boston Scientific makes IVL play with Bolt Medical acquisition
Boston Scientific (NYSE: BSX) announced today that it agreed to acquire intravascular lithotripsy (IVL) platform developer Bolt Medical. On a 100% basis — before considering an existing equity stake and other adjustments — the deal is valued at $600 million upfront with up to an additional $300 million upon achievement of certain regulatory … [Read more...] about Boston Scientific makes IVL play with Bolt Medical acquisition
CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
CardioFocus announced today that investigators completed the first series of treatments in a study of its OptiShot pulsed-field ablation system. The VISION AF clinical trial evaluates OptiShot as a treatment for paroxysmal AFib. Dr. Vivek Reddy of Mount Sinai and Dr. Petr Neužil of Na Homolce Hospital (Prague) performed the first cases. The … [Read more...] about CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
Abbott reports first cases with software-guided balloon-expandable TAVI
Abbott (NYSE:ABT) today announced the first patient procedures with its investigational transcatheter aortic valve implantation (TAVI) system. The company designed its investigational software-guided, balloon-expandable TAVI system to build a foundation for AI-guided procedures. It hopes to add the expandable system to its structural heart … [Read more...] about Abbott reports first cases with software-guided balloon-expandable TAVI
Shockwave Medical’s Javelin IVL catheter meets primary trial endpoints
Johnson & Johnson MedTech's Shockwave Medical unit today announced the first clinical outcomes associated with its Javelin catheter. Shockwave shared the first clinical outcomes associated with its Javelin peripheral intravascular lithotripsy (IVL) catheter system. It designed this novel, non-balloon-based lithotripsy platform to modify … [Read more...] about Shockwave Medical’s Javelin IVL catheter meets primary trial endpoints
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical … [Read more...] about FDA approves IDE for Medtronic Prevail drug-coated balloon
Endostart wins CE mark to bring magnetic balloon tech to enteroscopy
Endostart announced today that it received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety in endoscopic procedures. The technology utilizes a magnetic balloon system to enhance control of the endoscope in both the small and large bowel. It … [Read more...] about Endostart wins CE mark to bring magnetic balloon tech to enteroscopy
Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Abbott today announced new milstones supporting its suite of pulsed field ablation (PFA) solutions in electrophysiology. The company completed enrollment early for its VOLT-AF FDA investigational device exemption (IDE) study evaluating the Volt PFA system. It also launched its FOCALFLEX trial to assess its TactiFlex duo ablation catheter, … [Read more...] about Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Quasar Medical acquires balloon maker Ridgeback Technologies
Quasar Medical announced that it completed the acquisition of Ridgeback Technologies, a maker of cutting-edge catheter balloons. The company says Galway, Ireland-based Ridgeback's offerings enhance its full-service portfolio of minimally invasive medical devices. The company provides end-to-end manufacturing solutions for such devices and now … [Read more...] about Quasar Medical acquires balloon maker Ridgeback Technologies
Teleflex wins FDA clearance for perfusion balloon for PTCA
Teleflex (NYSE: TFX) announced today that the FDA has granted 510(k) clearance for the company's Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). The clearance expands Wayne, Pennsylvania–based Teleflex's interventional cardiology portfolio. It enables the company to offer what it says is the only … [Read more...] about Teleflex wins FDA clearance for perfusion balloon for PTCA
