Concept Medical Inc. (CMI) recently received FDA Investigational Device Exemption (IDE) approval for its Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of superficial femoral arteries (SFA).
Lower extremity peripheral arterial disease (PAD) — of which stenosed and occluded SFA remain a major contributor — affects an estimated quarter million adults in Europe and North America. PAD is associated with “significant morbidity and mortality, with atherosclerosis being the main cause”, according to CMI.
Treatment options for PAD are currently limited to uncoated PTA balloons, paclitaxel coated DCBs, and a DES. This restricts a physicians treatment plan choice and alternatives for patients, according to CMI. Uncoated balloons have shown recurrent re-narrowing of arteries, making the intervention suboptimal. Additionally, paclitaxel safety is still debated because of association of the drug with long-term mortality.
CMI said that Sirolimus could fill the gap in PAD safety and efficacy. The IDE approval will allow the company to initiate study to demonstrate MagicTouch PTAs safety and effectiveness in femoral and popliteal segments. Results from the study will then help support potential future pre-market approval from FDA.
MagicTouch PTA is CE-approved and already extensively commercially used in Europe, major markets of Asia, and Mid-Eastern markets. It is also the most clinically studied sirolimus drug coated balloon for PAD treatment, including the “largest head-to-head RCT against paclitaxel DCB, and the largest RCT against uncoated balloon,” according to the press release.
The announcement marks the fourth IDE approval for the company’s sirolimus coated balloons, having already received three for its SCB MagicTouch family of products for coronary in-stent restenosis, coronary small vessel, and below-the-knee indications.
"We are extremely proud to have received the fourth IDE approval from the USFDA for MagicTouch PTA in the SFA indication," said Dr. Manish Doshi, Founder of Concept Medical Group, in the press release.