Avinger (NSDQ:AVGR) today priced a follow-on offering worth $30 million, saying it plans to dip into the cash if it needs to cover penalties for missed revenue covenants this year. Redwood City, Calif.-based Avinger said it plans to float nearly 8.6 million shares at $3.50 apiece, plus a possible 1.3-million-share underwriters over-allotment that could bring in another […]
Vascular
FlowAid Medical wins CE Mark for sequential contraction compression device
Blood flow and circulatory enhancement focused device developer FlowAid Medical Technologies said yesterday it won CE Mark approval in the European Union for its FA100 SCCD sequential contraction compression device. The FA100 system uses electrically stimulated controlled contractions for sequential compression, eliminating the need for external compression and pressure to the leg, according to the […]
Spectranetics wins CE Mark for AngioSculptX drug-coated ‘scoring’ balloon
Spectranetics (NSDQ:SPNC) said today it won CE Mark approval in the European Union for its AngioSculptX drug-coated PTCA scoring balloon catheter designed to treat coronary artery stenosis. The device won indications for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restinosis, the Colorado Springs, Colo.-based company said. “AngiosculptX represents a unique coronary scoring […]
InSeal Medical wins CE Mark for vascular closure device
InSeal Medical said today it won CE Mark approval in the European Union for its InClosure vascular closure device designed to close large bore arterial punctures. The device is implanted percutaneously and requires no pre-procedure or sheath exchange and features a biodegradable membrane which is coupled to the vessel wall by a thin Nitinol frame, the […]
Endologix releases Q2, updates on Nellix discussions with FDA
Endologix (NSDQ:ELGX) on Wednesday released 2nd quarter earnings and updated on its discussions with the FDA over its Nellix system for treating abdominal aortic aneurysms, saying the agency is requesting additional information and may need an Advisory Committee Panel before it can obtain approval. The company said that without a required panel, it is hopeful it […]
Gore wins FDA nod for Tigris vascular stent
W.L. Gore & Associates said today it won FDA premarket approval for its Tigris self-expanding vascular stent designed for treating peripheral artery disease. The 3rd-generation dual-component stent features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, the Newark, Del.-based company said. “At Gore, […]
Essential Medical wins FDA IDE nod for vascular sealer
Essential Medical said today it won an Investigational Device Exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device. The 180-patient pivotal study will run across 10-16 sites in the U.S., Canada and the European Union, Malvern, Penn.-baed Essential Medical said. “The X-Seal device provides a necessary improvement to current closure devices. […]
Medtronic touts 1st enrollment in Reality PAD study
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 […]
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 […]