Shockwave Medical said today it won CE Mark approval in the European Union for its Shockwave S4 peripheral intravascular lithotripsy catheter. The Shockwave S4 is a low-profile catheter designed to treat calcified lesions below-the-knee arteries, which can be challenging to access and treat, and are often associated with critical limb ischemia. The company’s Lithoplasty devices are designed […]
Vascular
SurModics wins FDA nod for low-profile PTA balloon dilation catheter
SurModics (NSDQ:SRDX) said yesterday it won FDA 510(k) clearance for its .018″ low-profile percutaneous transluminal angioplasty balloon dilation catheter designed for peripheral vascular use. The newly cleared low-profile catheter features the Eden Prairie, Minn.-based company’s low-friction, low-particulate Serene hydrophilic coating with a range of between 2mm to 10mm. “We are delighted to announce this latest of three […]
Terumo’s Vascutek, Bolton Medical merge to form Terumo Aortic
Terumo Corp. (TYO:4543) said today its Vascutek subsidiary and Bolton Medical have merged together to form a new company, Terumo Aortic. The newly combined company is expected to have a revenue of more than $200 million, and will employ more than 1,100 individuals worldwide, Tokyo-based Terumo said. Terumo Aortic will look to accelerate its position in treating aortic […]
FDA approves Medtronic’s drug-coated balloon to treat long superficial femoral artery lesions
The FDA approved Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon to treat long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease, the medtech giant touted today. In a 227-patient global trial, participants treated with Medtronic’s drug-device combination therapy had a one-year patency rate of 89.1% and a clinically-driven target revascularization rate […]
FDA approves IDE trial for Urotronic’s drug-coated balloon
Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. Get the full story at our sister site, Drug Delivery Business News.
Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures. The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a […]
Intact Vascular raises $20m in Series C
Intact Vascular said today it raised $20 million in a Series C round of financing, with funds slated to support the company’s Tack endovascular system through the FDA pre-market approval process. The round was joined by major participants New Enterprise Associates, H.I.G. BioVentures and Quaker Partners, the Wayne, Penn.-based company said. The funding is slated […]
LimFlow raises $34m in Series C round
LimFlow said today it raised $33.5 million (EU €27 million) in an oversubscribed Series C round of financing to support its technology designed to treat critical limb ischemia. The round was led by Sofinnova Partners and joined by existing investors BpiFrance and Balestier, the Paris-based company said. As part of the funding round, Sofinnova venture […]
Asahi Intecc to begin direct sales of PCTA guidewires
Asahi Intecc said today it plans to begin direct sales of its coronary percutaneous transluminal coronary angioplasty guidewires in the US, which are currently only distributed by Abbott‘s (NYSE:ABT) vascular division. The shift will take place on July 1, at which time Asahi’s entire portfolio of PTCA guidewires will be available directly from it, the […]
Cardiva Medical wins expanded FDA indications for Vascade vascular closure system
Cardiva Medical said today it won expanded indications from the FDA for its Vascade vascular closure system, now cleared for use in 5-7F femoral venous closures in addition to arterial closure. The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by […]
Reva inks distro deal for bioresorbable scaffolds in Turkey
Reva Medical (ASX:RVA) inked a distribution deal with Kardionet Healthcare & Foreign Trading to launch commercial operations in Turkey for its bioresorbable scaffold tech, the company reported today. According to the terms of the deal, Kardionet will be responsible for sales, marketing, customer training and support for Reva’s Fantom and Fantom Encore bioresorbable devices in Turkey. […]