SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This makes it the first non-paclitaxel drug coated balloon to have two applications approved.
MedAlliance develops innovative drug-eluting balloons for patients suffering from life-threatening coronary and peripheral arterial disease. MedAlliance's DEB technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained drug release for up to 90 days. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance's proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.
The CE-certified SELUTION SLR that became the first drug-eluting balloon DEB to be awarded "Breakthrough Device Designation" by the FDA is undergoing clinical studies. The receipt of a second Investigational Device Exemption (IDE) approval marks another major milestone for MedAlliance has marked, allowing the company to launch clinical trials for its device for the treatment of occlusive disease of the superficial femoral artery (SFA).
"This is a significant milestone for MedAlliance: we are the first non-paclitaxel drug-coated balloon to receive IDE approval, and now the first to have two applications approved. This is the culmination of a multi-year R&D program to provide the comprehensive non-clinical data required to satisfy the very high standards expected by the US FDA," added Jeffrey B. Jump, MedAlliance Chairman and CEO. "We are very pleased with the rapid level of sales growth we are experiencing in Europe, Asia and South America and very much look forward to entering the US market."
Enrollment will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centers in the US and an additional 20 centers around the world. This study will enroll 300 patients to demonstrate superiority over balloon angioplasty (POBA). The Principal Investigator of this study is Dr George Adams, Director, Cardiovascular and Peripheral Vascular Research, Rex Hospital Inc., Raleigh, North Carolina, United States.
“We are very excited that US patients suffering from PAD will have the opportunity to receive this novel sirolimus drug coated balloon technology. This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly," commented Adams.
(Press release/RAN)
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