Endo Tools Therapeutics today announced that its Endomina suturing tool won FDA 510(k) clearance. The Belgium-based company designed the system for the endoscopic placement of sutures and approximation of soft tissue in the gastrointestinal tract in adults. Endomina has a universal triangulation platform and an instrument for tissue piercing … [Read more...] about Endomina suturing tool wins FDA clearance
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
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
The top stories from Medical Tubing + Extrusion in 2021
The medical device industry as a whole experienced a handful of innovations in 2021, but Medical Tubing + Extrusion's reader took a special interest in two catheter-based innovations last year. Here are our most popular articles of 2021: Links to articles: Cook Medical wins FDA breakthrough device designation for next-gen … [Read more...] about The top stories from Medical Tubing + Extrusion in 2021
Cordis names new CFO
Cordis today announced that it has appointed Christopher Scully as chief financial officer. Scully will be responsible for leading the interventional cardiovascular technology company’s financial and IT functions to accelerate Cordis’s growth. Prior to joining the company, Scully was executive VP and CFO for PPD. Get the full story on our … [Read more...] about Cordis names new CFO
Route 92 Medical raises $111M for its aspiration catheter to treat strokes
Route 92 Medical this week said it raised over $110 million in a combined Series E and debt financing round. Capital raised included $56 million in a Series E financing round led by new investors InnovaHealth Partners and Norwest Venture as well as existing investors The Vertical Group and U.S. Venture Partners. Runway Growth Capital … [Read more...] about Route 92 Medical raises $111M for its aspiration catheter to treat strokes
5 pediatric electrophysiology devices you need to know
The National Capital Consortium for Pediatric Device Innovation recently announced five electrophysiology devices that could monitor and treat congenital heart disease and arrhythmia in pediatric patients. The five winners of the annual NCC-PDI “Make Your Medical Device Pitch for Kids!” competition will share a $150,000 grant funding from the … [Read more...] about 5 pediatric electrophysiology devices you need to know
FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures
Urotronic today announced that it received FDA approval for its Optilume urethral drug-coated balloon for male urethral strictures. Plymouth, Minnesota–based Urotronic designed the paclitaxel-coated balloon to inhibit new scar tissue growth that can occur after endoscopic dilations. Urethral strictures are scars in or around the urethra that can … [Read more...] about FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures
Study: Stereotaxis robotic technology reduces silent cerebral embolism during AFib ablation
Stereotaxis announced the positive results from a study of its robotic magnetic navigation system in atrial fibrillation ablation. The multi-center, prospective study evaluated 166 patients with paroxysmal or persistent AFib who underwent pulmonary vein isolation using Stereotaxis' robotic magnetic navigation (RMN) technology or manual contact … [Read more...] about Study: Stereotaxis robotic technology reduces silent cerebral embolism during AFib ablation
Foldax gets greenlight in India for biopolymer surgical aortic heart valve clinical trial
Foldax this week announced that India's medical device regulatory body approved initiation of a clinical trial to study its Tria biopolymer surgical aortic heart valve. Salt Lake City-based Foldax designed the Tria heart valve to resist calcification, withstand stresses and strains without failure and restore patient quality of life without the … [Read more...] about Foldax gets greenlight in India for biopolymer surgical aortic heart valve clinical trial
