Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its TrailBlazer angled support catheter designed for use in the peripheral vascular system.
The Fridley, Minn.-based company’s newly cleared TrailBlazer cath is designed to support a guide wire during peripheral artery access to enable the delivery of solutions and diagnostic agents. Support catheters, such as the TrailBlazer, are commonly used in endovascular procedures to treat patients with peripheral artery disease.
“Medtronic is committed to providing physicians with meaningful innovations and therapy choices to enhance their peripheral treatment algorithm. Working with physicians, we have extended the Medtronic TrailBlazer support catheter portfolio to offer a broad suite of angled options for treatment of complex lesions both above and below the knee,” peripheral biz prez & GM Mark Pacyna said in a press release.
The TrailBlazer cath features a braided stainless steel shaft and a 25 and 30 degree angled tapered tip for accessing and crossing complex lesions, Medtronic said, with 3 radioopaque marker bands and a radiopaque shaft.
Earlier this month, Medtronic said it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients.
The medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study comparing the DCB treatment with standard percutaneous balloon angioplasty.
In-stent restenosis, which occurs when plaque forms around stents originally placed in arteries to restore blood flow, is estimated to occur in up to 40% of all superficial femoral artery stents, Medtronic said.
