FDA Clears Medtronic's TrailBlazer Guidewire Angled Support Catheter
By Jof Enriquez,
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Medtronic says the U.S. Food and Drug Administration (FDA) has cleared the company's TrailBlazer angled support catheter, which is used in endovascular procedures to support a guidewire and deliver solutions and diagnostic agents as part of the treatment of peripheral artery disease (PAD).
The TrailBlazer support catheter is an over-the-wire, single lumen seamless catheter with three embedded radiopaque markers for enhanced visibility, a 40 cm hydrophilic distal tip coating for smooth tracking through challenging vasculature, and an atraumatic, 25-30 degree angled tapered tip to cross complex lesions. The catheter features a braided stainless steel shaft for increased pushability, kink-resistant outer layer, and a lubricious inner layer to ensure smooth guidewire movement. Trailblazer catheters come in .014", .018" and .035" sizes, and are marketed as a procedural support product under the Peripheral Therapies business unit.
"Medtronic is committed to providing physicians with meaningful innovations and therapy choices to enhance their peripheral treatment algorithm," said Mark Pacyna, VP and GM of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic, in a news release. "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."
According to the Centers for Disease Control and Prevention (CDC), approximately 8.5 million people in the United States have peripheral artery disease, including 12-20 percent of individuals older than age 60. The disease involves the narrowing of or blockage of peripheral blood vessels as a result of the buildup of fatty plaque (atherosclerosis), and raises the risk of stroke and heart attacks. Beyond symptomatic and pharmacological therapy, complex cases of PAD can be treated with endovascular techniques.
Medtronic in the past two years has scored successive approvals and expanded indications for another minimally invasive, PAD-indicated endovascular product, the IN.PACT Admiral drug-coated balloon (DCB). It features a proprietary coating of the drug paclitaxel and a naturally occurring excipient called urea, which facilitates transfer of the drug from the balloon into the artery wall. This month, IN.PACT Admiral was cleared by FDA as the first DCB that has gained approval to treat in-stent restonosis (ISR) in the U.S., based on the IN.PACT Global Study, compared to a standard percutaneous balloon angioplasty (PTA) control.