Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system. Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It features a low-profile frame for avoiding obstruction of the … [Read more...] about FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position
Implants
4C Medical closes $35M Series C financing round, appoints CEO
4C Medical Technologies today announced that it completed a $35.4 million Series C financing round and appointed Saravana Kumar as president and CEO. The preferred stock financing round was led by MicroPort CardioFlow Medtech. As part of the closing, Kumar was appointed to lead the company after having served as interim president and CEO since … [Read more...] about 4C Medical closes $35M Series C financing round, appoints CEO
Synchron says study shows safety of its brain-computer interface implant
Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input. New York-based Synchron said this study demonstrated the safety of its … [Read more...] about Synchron says study shows safety of its brain-computer interface implant
Confluent Medical Technologies closes majority investment from TPG Capital
Confluent Medical Technologies announced that it closed a majority investment from TPG Capital following TPG’s agreement to acquire a majority stake in the company. Last month, Confluent Medical confirmed that TPG Capital signed a definitive agreement to acquire a majority stake in the company, joining existing investor Ampersand Capital … [Read more...] about Confluent Medical Technologies closes majority investment from TPG Capital
AtHeart Medical wins FDA approval for second phase of ASD occluder IDE study
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
CereVasc wins FDA IDE approval to begin eShunt pilot study
CereVasc today announced that it received an FDA investigational device exemption approval to begin a trial of the eShunt for normal pressure hydrocephalus. The Boston-based company can initiate its pilot trial of the eShunt system in patients with normal pressure hydrocephalus (NPH). The eShunt device offers a minimally invasive treatment with … [Read more...] about CereVasc wins FDA IDE approval to begin eShunt pilot study
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
Alcon closes Ivantis acquisition
Alcon (NYSE:ALC) announced today that it completed its $475 million acquisition of glaucoma surgery device maker Ivantis. Geneva, Switzerland-based Alcon initially announced the acquisition of Ivantis, which develops the Hydrus Microstent minimally invasive glaucoma surgery (MIGS) device, in November 2021. According to a news release, the … [Read more...] about Alcon closes Ivantis acquisition
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
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
