AxoGen (NSDQ:AXGN) today expanded a study of its Avance graft for treating peripheral nerve damage on a pre-specified statistical analysis, sending its share price down slightly today. Alachua, Fla.-based AxoGen is adding 50 patients and five new centers to the Recon study of Avance, a human allograft designed to bridge severed nerves without a second surgical […]
FDA approves Intact Vascular’s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient […]
FDA clears Contego Medical’s Vanguard IEP peripheral balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function. “Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues […]
Ra Medical reaps $86m with IPO
Ra Medical (NYSE:RMED) said yesterday that its initial public offering brought in more than $86 million by the time it closed, including an underwriter’s option that added some $10 million to the take. The $17-per-share flotation of 4.5 million shares was bolstered by the 585,000-share over-allotment, for gross proceeds of $86.2 million. Carlsbad, Calif.-based Ra Medical, which makes the […]
Cook Medical wins FDA nod for 5mm Zilver PTX stent
Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. Get the full story at our […]
Ra Medical sets range for $50m IPO
Ra Medical yesterday set the terms for its forthcoming initial public offering, which would fetch $50 million at the midpoint. The Carlsbad, Calif.-based company said it plans to float 3.3 million shares at $14 to $16 apiece, for gross proceeds of $46.7 million to $53.3 million. At the midpoint the flotation would gross $50.0 million, according […]
Medtronic closes $28m buyout of QT Vascular’s Chocolate PTA balloon
Medtronic (NYSE:MDT) closed the $28 million acquisition of the Chocolate PTA non-drug-coated balloon made by QT Vascular, after taking an option on the device last year. In February 2017 the companies inked a 5-year deal calling for Medtronic to distribute the Chocolate PTA device. Last May the Fridley, Minn.-based medical device giant agreed to the option deal on Chocolate PTA, which […]
SurModics wins FDA nod for Telemark crossing microcatheter
SurModics (NSDQ:SRDX) said today that it won 510(k) clearance from the FDA for its Telemark 0.014″ coronary and peripheral microcatheter, saying it plans to have the device on the U.S. market “in the coming months.” The Eden Prairie, Minn.-based medical device company said Telemark combines its Xtreme composite shaft technology with its Pristyne hydrophilic coating and […]
Avinger bids for FDA nod for new Pantheris atherectomy device
A day after announcing CE Mark approval for the next generation of its Pantheris atherectomy device, Avinger (NSDQ:AVGR) said it’s seeking a similar nod from the FDA. The bid for 510(k) clearance from the federal safety watchdog for the image-guided device covers new features including a simpler, single-balloon system designed both for apposition and blood flow occlusion and […]
Avinger wins CE Mark for next-gen Pantheris atherectomy device
Avinger (NSDQ:AVGR) said today that it won CE Mark approval in the European Union for the next generation of its Pantheris image-guided atherectomy device. Redwood City, Calif.-based Avinger said the new device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. It’s designed to treat blocked […]
Study: Catheter thrombolysis doesn’t lower risk of post-thrombotic syndrome, raises bleeding risk
A study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding. The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm […]
- 1
- 2
- 3
- …
- 14
- Next Page »
MassDevice Network
@MassDevice
LinkedIn
YouTube