Medtronic (NYSE:MDT) said yesterday it enrolled the 1st patients in the VIVA-sponsored Reality study assessing outcomes of peripheral artery disease patients treated with directional atherectomy and drug-coated balloons. The study is slated to enroll up to 250 subjects across 15 sites, investigating the use of Medtronic’s HawkOne, TurboHawk and In.Pact Admiral DCB for calcified and […]
Vascular
Penumbra touts stent retriever study data
Penumbra (NYSE:PEN) said a 198-patient trial of its next-generation stroke-treatment device along with another company product showed promise, meeting primary endpoints. Results were positive enough that a 2016 regulatory submission remains part of the plan. “The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to […]
Mercator MedSystems launches BTK micro-infusion trial
Mercator MedSystems said today it enrolled the 1st patient in the Limbo-ATx trial of the company’s Bullfrog micro-infusion device. The trial is slated to enroll 120 patients and aims to explore the benefit of localized drug delivery using the company’s device in maintaining vascular health when used alongside atherectomy procedures, the company said. “This is a very […]
UPDATE: Stryker recalls select re-sterilized AngioDynamics Soft-VU angio caths
Updated to include comment from Stryker and to adjust “reprocessed” language to “re-sterilized” Stryker‘s (NYSE:SYK) Sustainability Solutions biz said it recalled a select number of re-sterilized AngioDynamics (NSDQ:ANGO) Soft Vu omni flush angiographic catheters due to reports of tip separation. AngioDynamics said it is not associated with the recall, and that the devices affected have their own […]
FDA approves Vasorum’s Celt ACD vascular closure device
Vasorum said today that it won pre-market approval from the FDA for its Celt ACD vascular closure device. The Dublin-based company said the Celt ACD is designed to close punctures to the femoral artery after catheterization, using a biocompatible implant on both the inside and outside of the arterial wall. Vasorum said the PMA approval was based on a […]
Essential Medical wins CE Mark for Manta vascular closure device
Essential Medical said today that it won CE Mark approval in the European Union for its Manta vascular closure device. The device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website. “We are thrilled to have approval to sell Manta and have […]
Pavmed eyes Q4 FDA submission for PortIO vascular access device
Pavmed (NSDQ:PAVMU) said today that it’s planning to submit an application for FDA clearance for its 1st product, the PortIO long-term implantable vascular access device, during the 4th quarter. New York City-based Pavmed said the PortIO device is in the verification and validation testing phase, the final stage of pre-submission testing. The company has 4 other […]
AngioDynamics jumps on Street-beating Q4 earnings
AngioDynamics (NSDQ:ANGO) shares jumped today after the company reported fiscal 4th-quarter and 2016 results that beat Wall Street’s consensus forecast. The Latham, N.Y.-based company posted losses of -$44.0 million, or -$1.21 per share, on sales of $93.4 million for the 3 months ended May 31, for a top-line gain of 2.7%. And although losses widened by some 5,300% […]
FDA approves trial for Essential Medical’s Manta vascular closure device
Essential Medical said today that it won an investigational device exemption for a clinical trial of its Manta vascular closure device. The Manta device is designed to close punctures in less than 1 minute, providing immediate hemostasis, using absorbable biomaterials in an “anchor/plug” sealing technology, according to Essential Medical’s website. The U.S. pivotal study is designed to assess […]
Lombard expands EU launch of Altura AAA endograft system
Lombard Medical Technologies (NSDQ:EVAR) said today it expanded the European launch of its Altura endovascular stent graft to the Netherlands and Spain, touting 4 completed procedures with the device in the newly expanded regions. The Altura endograft system is designed as a transcatheter treatment for abdominal aortic aneurysms, and can be repositioned during deployment to allow for […]
Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months. The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA […]