Concept Medical has been granted “CE Certification” for Magic Touch PTA 0.035 OTW (Percutaneous Transluminal Angioplasty) its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease.
MagicTouch PTA prevents the re-narrowing of superficial femoral and popliteal arteries in patients with peripheral artery disease. An excellent alternative for revascularization of peripheral arteries.
The catheter is intended to treat patients with peripheral artery disease (PAD). It is based on the company’s Nanolute Technology sirolimus drug delivery platform.
Concept Medical has pioneered the Sirolimus drug delivery platform technology (Nanolute Technology), which has a proven commercial history in the coronary applications in more than 30,000 patients worldwide. MagicTouch PTA Sirolimus coated balloon is developed using this Nanolute Technology for use in PAD.
MagicTouch PTA safety and efficacy are being assessed in a clinical study involving patients with peripheral artery disease.
Study principal investigator Dr. Edward Choke noted that approximately 80% of the subjects did not have any patent peripheral arteries before angioplasty.
Dr. Edward Choke added that Concept Medical’s device showed a favorable profile, with 100% freedom from the device and procedure-related mortality and a 97% limb salvage rate at 30 days.
Freedom from clinically-driven target lesion revascularization (TLR) was recorded at 91%, while primary patency evaluated using duplex ultrasound was 82% at six months.
Peripheral vascular disease is a circulatory problem in which the peripheral blood vessels – usually the arteries of the legs – are starved of blood supply due to narrowing, blockage, or spasm of the supplying blood vessels. If peripheral vascular disease (PVD) occurs only in the arteries, it is called peripheral artery disease (PAD).
Most of the time, PAD results from a narrowing of the lumen of the blood vessels caused by inflammation, plaque buildup, or tissue damage. Diabetes is a significant risk factor for PAD – more than 85% of patients with diabetes will develop PAD in their lifetime.
On August 14, 2019 — Concept Medical has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA. The breakthrough device designation granted to MagicTouch PTA, offers Concept Medical, an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way.
Date: 27/05/2020
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