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
Catheters
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
ICU Medical completes $2.35B purchase of Smiths Medical
ICU Medical (NASDAQ:ICUI) recently announced that it has completed its $2.35 billion acquisition of Smiths Medical from the Smiths Group. Smiths Medical's business includes syringe and ambulatory infusion devices, vascular access, and vital care products. The merger creates an infusion therapy company with estimated annual revenues of roughly … [Read more...] about ICU Medical completes $2.35B purchase of Smiths Medical
Medtronic Evolut Pro TAVR wins approval in China
Medtronic today announced that it received National Medical Products Administration approval in China for its CoreValve Evolut Pro TAVR system. The approval marks the first Medtronic TAVR system approved in China for patients with symptomatic severe aortic stenosis who are at high or extreme risk for open-heart surgery, according to the … [Read more...] about Medtronic Evolut Pro TAVR wins approval in China
Medtronic to acquire cardiac arrhythmia treatment developer Affera
Medtronic (NYSE:MDT) announced today that it agreed to acquire cardiac mapping and ablation technology developer Affera. Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for … [Read more...] about Medtronic to acquire cardiac arrhythmia treatment developer Affera
VitalPath acquires Modern Catheter Technologies
VitalPath announced today that it acquired catheter delivery system developer Modern Catheter Technologies. The Roseville, Minnesota-based company said in a news release that the acquisition builds upon its acquisition of VitalDyne in March 2021. Get the full story at our sister site, Medical Design & Outsourcing. … [Read more...] about VitalPath acquires Modern Catheter Technologies