MicroPort CardioFlow Medtech Corp. today announced that it received CE mark for its second-generation aortic valve implant. The VitaFlow Liberty transcatheter aortic valve implant (TAVI) device and retrievable delivery system received EU CE-MDR certification. CardioFlow's implant helps patients avoid open-heart surgery and delivers minimal … [Read more...] about CardioFlow wins CE mark for VitaFlow Liberty TAVI system
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Medtronic launches Steerant aortic guidewire
Medtronic (NYSE:MDT) today announced the launch of its Steerant aortic guidewire in the U.S. and Canada following the first patient cases. The medtech giant tailored Steerant to facilitate catheter placement and exchange during diagnostic or interventional aortic procedures. It designed the guidewire to support endovascular aneurysm repair … [Read more...] about Medtronic launches Steerant aortic guidewire
Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
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
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
Stereotaxis to acquire Access Point Technologies and its EP catheters
Stereotaxis (NYSE: STXS) is purchasing a Minneapolis-based electrophysiology (EP) catheter maker to further enhance its minimally invasive endovascular surgical robotics technology. St. Louis–based Stereotaxis did not disclose how much it is paying for Access Point Technologies in its after-hours news release. The transaction, paid with … [Read more...] about Stereotaxis to acquire Access Point Technologies and its EP catheters
