Clinical stage medical device company XableCath said today it won FDA clearance for its blunt tip support vascular catheter. The Salt Lake City, Utah-based company said the blunt tip catheter is designed to allow for the the true lumen passage of lesions both above and below the knee in the peripheral vasculature for treating peripheral […]
Vascular
Singapore vascular access dev Advent Access raises $2m in pre-Series A
Singapore-based vascular access dev Advent Access has raised $1.9 million (SGD $2.6 million) in a pre-Series A financing round to support its av-Guardian technology designed to create vascular access for dialysis patients. The funding round was led by Accuron MedTech, which the company touted as the largest medical device company in southeast Asia. The investment […]
PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study
PQ Bypass said today it won FDA investigational device exemption approval to launch a pivotal clinical trial of its Detour percutaneous femoropopliteal bypass system designed to treat patients with peripheral artery disease. The company’s Detour II clinical trial will look to enroll up to 292 patients with lower limb ischemia due to long blockages over 15 […]
Medtronic wins CE Mark for Endurant stent graft, HeliFX EndoAnchor combo
Medtronic (NYSE:MDT) this week won CE Mark approval in the European Union for combined treatment with its Endurant II or IIs stent graft and the Heli-FX EndoAnchor system in patients with short aortic anatomies. The combined treatment is now cleared with indications to that patients with aortic neck lengths down to 4mm with a less than […]
Lexington Biosciences moves forward with its affordable heart diagnostic device
Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device. The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial […]
Cordis, Medinol win FDA nod for Elunir drug-eluting stent
Cordis and Medinol announced today that the FDA approved its Elunir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in the U.S., according […]
Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat
A federal appeals court has affirmed an earlier ruling by the Patient Trial and Appeal Board of the U.S. Patent and Trademark Office, invalidating 22 claims of a patent owned by United Therapeutics (NSDQ:UTHR). The patent covered treprostinil, the active ingredient in both SteadyMed‘s (NSDQ:STDY) Trevyent and United Therapeutics’ Remodulin. The court’s ruling sent STDY shares up 8% today, trading […]
Stryker touts NEJM publication of Trevo thrombectomy device trial results
Stryker (NYSE:SYK) yesterday released results from the Dawn trial of its Trevo thrombectomy device, touting significant effects even when used beyond six hours after stroke. Results from the trial were published in the New England Journal of Medicine, the Kalamazoo, Mich.-based company said. “By quadrupling the size of the therapeutic time window, the consequence of Dawn […]
Avinger slashes jobs, Q3 sales down 61%
Avinger (Nasdaq:AVGR) – maker of the Lumivascular image-guided, catheter-based system to treat peripheral artery disease (PAD) – continued to experience declining sales as it retrenched during the third quarter, according to its newest earnings report. The Redwood, Calif.–based company has been cutting jobs and other costs– and focusing on existing accounts and winning FDA clearance for […]
India signals shift on stent pricing cap
India’s National Pharmaceutical Pricing Authority is slated to revisit its decision to impose price caps on coronary stents in February of 2018 and it is looking for input from manufacturers, the agency said in a statement last week. The NPPA capped prices for drug-eluting stents and bioresorbable scaffolds in February this year, while also cutting […]
Stryker wins FDA HDE nod or Neuroform Atlas wide-neck aneurysm stent
Stryker (NYSE:SYK) said today it won humanitarian device exemption from the FDA for its Neuroform Atlas stent system designed to be used with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms. The newly HDE-cleared Neuroform Atlas is a nitinol stent designed to be used with metal coils to pack aneurysms in the brain. The system […]