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cook medical

Cook Medical wins FDA nod for 5mm Zilver PTX stent

September 24, 2018 By Brad Perriello

Cook Medical's Zilver PTX 5mm

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. “We spend a lot of time […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: cook medical, Peripheral Artery Disease

TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent

September 24, 2018 By Sarah Faulkner

Boston Scientific

On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular, Wall Street Beat Tagged With: abbott, biosensors, Biotronik, Boston Scientific, cook medical, Medtronic, TCT 2018

Cook Medical touts launch, first use of Advance CS, Compass CT systems

July 18, 2018 By Fink Densford

Cook Medical

Cook Medical today announced the launch and first use of its Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer designed for treating heart failure patients. The CS catheter is a percutaneous balloon infusion catheter designed for use in retrograde coronary sinus infusion procedures to infuse therapeutic agents into the heart via the […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Vascular Tagged With: cook medical

Medtech stories we missed this week: June 8, 2018

June 8, 2018 By Danielle Kirsh

missed-medtech-0323

From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Neurological, Patient Monitoring, Regulatory/Compliance Tagged With: branchpointtechnologies, cook medical, medtech, NeuroPace, Pentax Medical, rodomedical, Royal Philips, spineology, taewoonmedical

Veryan’s helical stent meets safety, efficacy endpoints after 12 months

February 9, 2018 By Sarah Faulkner

Veryan Biomimics

Veryan‘s helical BioMimics 3D stent met its primary safety and efficacy endpoints in a study of 271 patients with symptomatic femoropopliteal artery disease, according to TCTMD. The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents. The probability of maintaining primary patency after 12 months was […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular, Wall Street Beat Tagged With: C.R. Bard, cook medical, Medtronic, Spectranetics, veryan

VIVA 17 Round-up: Medtronic touts real-world data for In.Pact Admiral drug-coated balloon

September 12, 2017 By Sarah Faulkner

Medtronic

Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Data from the In.Pact Global study showed a 83.3% rate of freedom from clinically-driven target […]

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Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: acotecscientific, C.R. Bard, cook medical, Medtronic, Mercator MedSystems, Royal Philips, SurModics Inc.

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