The FDA says a recall of Teleflex (NYSE:TFX) intra-aortic balloon (IAB) catheter kits is Class I, the most serious kind of recall. Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 … [Read more...] about Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
Cardiology
InnovHeart has first in-human implantation of its TMVR
InnovHeart (Newton, Massachusetts and Milan) announced the first trans-septal clinical trial implant of its proprietary Saturn transcatheter mitral valve. According to the company, there were excellent hemodynamic results for the patient — a 79-year-old woman suffering from severe mixed (degenerative and functional) mitral regurgitation. The … [Read more...] about InnovHeart has first in-human implantation of its TMVR
FastWave reports positive 30-day results in first-in-human IVL study
FastWave Medical today announced successful 30-day results from the first-in-human study of its intravascular lithotripsy (IVL) technology. Minneapolis-based FastWave develops laser-based IVL technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output. The system helps to … [Read more...] about FastWave reports positive 30-day results in first-in-human IVL study
Surmodics to be acquired by private equity firm for $627M
Surmodics (Nasdaq:SRDX) announced today that it agreed to be acquired by GTCR, a private equity firm with healthcare interests. Eden Prairie, Minnesota-based Surmodics develops a range of technologies, including drug-coated balloons and thrombectomy systems. Its SurVeil DCB received a long-awaited FDA approval in June 2023. The company also … [Read more...] about Surmodics to be acquired by private equity firm for $627M
Philips prices $758.6M offering, expands access to intracardiac echocardiography
Philips announced that it priced an offering worth $758.6 million (€700 million) in fixed-rate notes. The notes, due in 2032, fall under the Philips European Medium Term Note (EMTN) program. Issuance will have a debt-neutral effect, with proceeds earmarked for the repayment of debt in 2024 and 2025. This follows last year's pricing of a $546.2 … [Read more...] about Philips prices $758.6M offering, expands access to intracardiac echocardiography
Vantis Vascular raises $5M for microcatheter, IVL system
Vantis Vascular announced today that it closed a $5 million SAFE (Simple Agreement for Future Equity) financing round. The company can convert the financing upon its future Series C preferred financing round. It brings the total funding for the company to $24 million to date. San Jose, California-based Vantis plans to use the funds to advance … [Read more...] about Vantis Vascular raises $5M for microcatheter, IVL system
Atraverse wins FDA nod for left-heart access device, raises $12.5M
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device. The novel device enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, the founder of Farapulse, invented the Hotwire system with co-founder Eric Sauter. It's the … [Read more...] about Atraverse wins FDA nod for left-heart access device, raises $12.5M
Medtronic pulsed field ablation system wins approval in Japan
Medtronic (NYSE: MDT) announced today that its PulseSelect pulsed field ablation (PFA) system has won regulatory approval in Japan. The regulatory nod in Japan further expands the reach of the system, which in December became the first PFA system approved in the United States to treat paroxysmal and persistent atrial fibrillation (AFib). Since … [Read more...] about Medtronic pulsed field ablation system wins approval in Japan
Farapulse founder’s Field Medical begins first-in-human pulsed field ablation trial
Field Medical announced today that it began the first-in-human study of its FieldForce pulsed field ablation (PFA) system. The company began its study evaluating FieldForce at Na Homolce Hospital in Prague, Czech Republic. It expects the VCAS study to enroll up to 60 patients at up to five sites around the world. Cardiff-by-the-Sea, … [Read more...] about Farapulse founder’s Field Medical begins first-in-human pulsed field ablation trial
CereVasc can begin new IDE study of eShunt
CereVasc announced today that it received FDA investigational device exemption (IDE) approval to begin a pivotal study of its eShunt. The FDA said the Boston-based company can initiate the STRIDE pivotal study looking at eShunt in treating normal pressure hydrocephalus. IDE approval allows the company look at the novel system's safety and … [Read more...] about CereVasc can begin new IDE study of eShunt
