BD (NYSE: BDX) recently issued a medical device correction later related to its Bard subsidiary's Rotarex atherectomy system. The company identified a number of anatomical factors that could contribute to catheter helix fracture and/or breakage. It reports 30 serious injuries and four deaths associated with the issue. Additionally, BD reported … [Read more...] about BD warns on atherectomy catheters after deaths
Regulatory
Medline has a Class I arterial catheter recall
The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall. This recall involves removing certain devices from where they are used or sold. The company reports no injuries or deaths related to this recall to date, according to an FDA notice. Medline designed its arterial catheter for … [Read more...] about Medline has a Class I arterial catheter recall
Stereotaxis Magic ablation catheter is now CE mark approved
Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter. The St. Louis–based robotic surgery company submitted Magic for both CE mark and FDA approval nearly a year ago; it still awaits an FDA nod in the U.S. Magic performs cardiac ablation procedures to treat … [Read more...] about Stereotaxis Magic ablation catheter is now CE mark approved
Imperative Care wins FDA clearance for Zoom stroke treatment
Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system. According to Campbell, California–based Imperative Care, the Zoom system is the first such system to include large-bore .088-in. catheters indicated for both access and aspiration when used with one of the company's … [Read more...] about Imperative Care wins FDA clearance for Zoom stroke treatment
Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter. The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping … [Read more...] about Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Medtronic gets CE mark for Harmony transcatheter pulmonary valve
Medtronic today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system. About 1.3 children around the world each year are born with congenital heart disease, according to the Minneapolis-based nonprofit Children's HeartLink. The Harmony system provides a minimally invasive alternative to open-heart surgery for … [Read more...] about Medtronic gets CE mark for Harmony transcatheter pulmonary valve
IceCure earns European patent win for next-gen cryoablation tech
IceCure Medical (Nasdaq:ICCM) announced today that it received an intention to grant notice from the European Patent Office. The notice covers the company's invention titled "Cryogenic System Connector," which recently received a patent in the U.S., too. Caesarea, Israel-based IceCure designed it to work as part of its XSense cryoablation … [Read more...] about IceCure earns European patent win for next-gen cryoablation tech
FDA approves Merit Medical’s cell-impermeable endoprosthesis
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, Utah–based Merit Medical designed Wrapsody to extend long-term vessel patency in dialysis patients. It … [Read more...] about FDA approves Merit Medical’s cell-impermeable endoprosthesis
Roivios wins FDA IDE for renal assist device
Roivios announced that it received FDA investigational device exemption (IDE) approval to conduct a trial for its renal assist device (RAD). The company can now move forward with a pivotal trial for the JuxtaFlow RAD for treating cardiac surgery patients with renal insufficiency. This IDE follows FDA breakthrough device designation for JuxtaFlow … [Read more...] about Roivios wins FDA IDE for renal assist device
Boston Scientific updates instructions for cryoablation catheters after reported deaths
The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific … [Read more...] about Boston Scientific updates instructions for cryoablation catheters after reported deaths