Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure. In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat […]
Peripheral
Vesper Medical raises another $37m for Duo venous stent
Vesper Medical said today that it raised a $37 million funding round for the Duo venous stent it’s developing. The round, which follows an $11 million Series A round the Wayne, Pa.-based company landed a year ago, was led by Vensana Capital and Gilde Healthcare, joined by existing backers New Enterprise Assoc. and Quaker Partners. Vesper […]
Boston Scientific wins FDA approval for Vici peripheral venous stent
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for the Vici peripheral venous stent it acquired when it bought Veniti last year. Marlborough, Mass.-based Boston Scientific said the FDA approved Vici for treating iliofemoral venous obstructive disease. The company inked a deal worth up to $160 million last August to acquire the […]
Axogen shares slip on expanded Avance nerve graft study
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 […]