AtHeart Medical recently announced that it received FDA approval to commence the second phase of its Ascent ASD investigational device exemption pivotal trial. Switzerland-based AtHeart Medical is evaluating the safety and efficacy of the reSept atrial septal defects (ASD) occluder in a prospective, single-arm study. The reSept device is … [Read more...] about AtHeart Medical wins FDA approval for second phase of ASD occluder IDE study
Catheters
Ra Medical Systems wins patent for laser ablation support catheter
Ra Medical Systems today said it received a patent from the U.S. Patent and Trademark Office for a support catheter used with a small flexible liquid core catheter for laser ablation. The Carlsbad, California-based company was granted its 10th patent for the support catheter that is to be used in conjunction with the Dabra liquid core ablation … [Read more...] about Ra Medical Systems wins patent for laser ablation support catheter
CoreMap raises $23 million to fund AFib mapping development
CoreMap today announced it closed a $20 million Series B financing to accelerate the development of its cardiac arrhythmia diagnostic technology and launch pilot studies. The Burlington, Vermont–based company said it also closed on a $3 million Series A Milestone financing that was part of its $10.5 million Series A in September 2020. In … [Read more...] about CoreMap raises $23 million to fund AFib mapping development
Zeus launches multi-lumen tubing for steerable catheters
Zeus Industrial Products today announced that it has launched its PTFE Sub-Lite-Wall multi-lumen tubing to its product portfolio. Orangeburg, S.C.-based Zeus designed the multi-lumen tubing for steerable catheters. It has ultra-thin walls, certified USP Class VI biocompatibility, high structural integrity, improved planarity, high lubricity and … [Read more...] about Zeus launches multi-lumen tubing for steerable catheters
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren't limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices … [Read more...] about The top 10 catheter innovations of 2021
Hantel appoints VP of business development
Hantel recently announced that it appointed Ron Balogh as VP of business development. The Hayward, California-based medtech design and contract manufacturing company appointed Balogh on Jan. 3. He will be responsible for serving the company's current clients and growing the company by improving communications and its presence within the … [Read more...] about Hantel appoints VP of business development
Medtronic’s recall of HawkOne system is Class I
The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind. So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial … [Read more...] about Medtronic’s recall of HawkOne system is Class I
FDA grants PMA for Cardiovascular Systems, OrbusNeich Scoreflex scoring balloon
Cardiovascular Systems and OrbusNeich this week announced that the OrbusNeich Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter has received FDA premarket approval. Scoreflex NC is a force PTCA scoring balloon with a dual-wire system that creates a focal stress pattern for safe and controlled plaque modification … [Read more...] about FDA grants PMA for Cardiovascular Systems, OrbusNeich Scoreflex scoring balloon
Junkosha boosts production of PTFE liners and FEP-based heat shrink
Junkosha announced today that it plans to double production capacity to meet shortages of PTFE liners and FEP-based heat shrink for catheter manufacturers. Both OEMs and contract manufacturers in the catheter space are stressed from shortages in the global supply of vital components, according to the Japanese maker of sophisticated fluoropolymer … [Read more...] about Junkosha boosts production of PTFE liners and FEP-based heat shrink
Cardiovascular Systems’ recall of its Wirion embolic protection device is Class I
The FDA determined that Cardiovascular Systems’ recall of some of its Wirion embolic protection devices is Class I, the most serious kind. St. Paul, Minnesota–based Cardiovascular Systems is recalling all products and lots of its Wirion embolic protection device due to complaints of filter breakage during retrieval. It includes devices with … [Read more...] about Cardiovascular Systems’ recall of its Wirion embolic protection device is Class I