W.L. Gore & Associates said today it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging anatomies. The newly cleared Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic […]
Vascular
Avenu Medical wins CE Mark for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won CE Mark approval in the European Union for its Ellipsys vascular access image-guided catheter system designed to percutaneously create arteriovenous fistulas for hemodialysis access. The company also said it won investigational device exemption approval from the FDA for the device, claiming it is the 1st device […]
Cordis recalls Precise Pro RX carotid stent over separation issues
Cardinal Health (NYSE:CAH) subsidiary Cordis recently revealed a voluntary recall of its Precise Pro RX nitinol carotid stent system based on issues with shaft separation during stent deployment. The issue was discovered after the company received complaints about separation difficulties with the stent, which is indicated for use in patients with stenotic lesions of the carotid artery, […]
OrbusNeich expands into PAD
OrbusNeich said today it expanded its portfolio to include its Jade and Scoreflex percutaneous transluminal angioplastyballoon devices designed to treat peripheral artery disease. The balloon devices are OrbusNeich’s 1st foray into lower limb and arteriovenous fistula intervention, the Hong Kong-based company said. “Broadening our offering to include peripheral products is a natural progression for OrbusNeich. […]
Renal Dynamics launches post-market trial for Redy 3rd-gen renal denervation device
Renal Dynamics said it launched a post-market study of its Redy renal denervation device for treating hypertension, after winning CE Mark approval for the device last November. Zug, Switzerland-based Renal Dynamics, which is owned by the Hobart Group, said the 1st patient in the trial was successfully treated at Novosibirsk, Russia’s Meshalkin State Research Institute of Circulation Pathology. […]
Humacyte launches pivotal trial for lab-grown blood vessel
Humacyte is launching a Phase III study of its lab-grown blood vessel Humacyl in 350 patients with end-stage renal disease who are on hemodialysis and don’t qualify for a standard surgical treatment, and Boston’s Brigham & Women’s Hospital plans to take part. Plans to move ahead to Phase III follow a promising Phase II clinical study […]
B. Braun inks exclusive distro deal with NuMed for CP stent
B. Braun Interventional Systems said today it extended its exclusive U.S. distribution deal with NuMed for to include its newly-cleared Cheatham Platinum stent designed to treat native or recurrent coarctation of the aorta. The CP stent won FDA 510(k) clearance in March, and the commercial launch in the U.S. is scheduled to take place this week, […]
Medtronic touts VenaSeal data
Medtronic (NYSE:MDT) today released clinical data from a study of its VenaSeal closure system, claiming consistent long-term durability and improved quality of life in patients with venous reflux disease treated with the system The VenaSeal system from the Fridley, Minn.-based medical giant uses a proprietary medical adhesive to close superficial veins in lower extremities in patients […]
Medtronic touts Endurant stent graft data, lowered mortality
Medtronic (NYSE:MDT) today released data from the Engage global registry study of its Endurant abdominal aortic aneurysm stent graft, touting lowered mortality and rupture rates compared to the earlier Evar 1 trial. Data from the studies was presented at the 2016 Charing Cross Symposium in London, Fridley, Minn.-based Medtronic said. “In the comparison analysis of Engage and […]
Gore wins Health Canada approval for Excluder stent graft
W.L. Gore & Associates said today it won Health Canada approval for its Excluder iliac branch endoprosthesis designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The IBE device is designed to be used in conjunction with Gore’s Excluder AAA endoprosthesis for treating abdominal aortic aneurisms. The Excluder device is designed […]
Advanced Catheter Therapies inks deal with Toray Industries for peripheral catheter
Advanced Catheter Therapies said today that it inked a worldwide license deal with Toray Industries for the manufacture and sale of ACT’s Occlusion Perfusion Catheter for peripheral vascular stenosis and restenosis. Chattanooga, Tenn.-based ACT said it’s been manufacturing the OPC device for about a year for clinical trials and a test release. “Our 1st-in-human clinical trials have been very […]