May 2, 2019 — Concept Medical Inc. (CMI) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for MagicTouch, its sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).
ISR is the gradual re-narrowing of a stented coronary artery lesion, due to subsequent tissue proliferation at the stented site. ISR is observed in about 10 percent of patients who undergo a drug eluting stent (DES) implantation and in more than 30 percent of patients who undergo bare-metal stent (BMS) implantation. Such patients, who come back with re-clogging of the coronary arteries following an earlier procedure of a bare metal or a drug-eluting stent implant, are candidates for treatment with the MagicTouch.
MagicTouch, which has CE approval, features a drug delivery technology platform coated onto the balloon designed to deliver sub-micron particles of sirolimus that are then encapsulated in a biocompatible drug carrier. The drug and carrier complex are designed to reach the inner layers of the vessel walls and act as a reservoir for long-term release of sirolimus. CMI has accumulated significant clinical data and initiated many ongoing/upcoming clinical programs for MagicTouch.
The goal of the FDA Breakthrough Devices Program is to provide patients and healthcare providers in the U.S. with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization.
The Breakthrough Devices Program offers manufacturers 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. This can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Under the program, FDA will provide CMI with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
“I was very impressed by the angiographic and IVUS [intravascular ultrasound] results of MagicTouch in ISR in the Brazil-ISR study. I didn’t encounter any safety or toxicity concerns in the course of the trial,” said Alexandre Abizaid, M.D., Ph.D., chief of coronary interventions at Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil.
For more information: www.conceptmedicals.com