Concept Medical

Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system.

MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey.

The balloon offers a controlled and sustained release of sirolimus. It mirrors the capabilities of a drug-eluting stent but without the necessity of a permanently implanted scaffold. Concept Medical aims to assess the safety and efficacy of its DCB in the trial with a focus on patients avoiding target lesion failure (TLF) at one year post-procedure. The study began under the guidance of Dr. Martin Leon, Dr. Azeem Latib and Dr. Ajay J. Kirtane.

Concept Medical said that its MAGICAL-ISR study underscores its “dedication to clinical excellence and innovation.”

“We a…

Concept Medical this week announced it received FDA investigational device exemption (IDE) approval for its sirolimus-coated balloon MagicTouch PTA to treat superficial femoral arteries.

The approval is the fourth for the Tampa, Florida-based company’s sirolimus-coated balloon. It has IDE approval for coronary in-stent restenosis, coronary small vessel and below-the-knee indications.

Concept Medical’s new IDE approval will allow Concept Medical to initiate a pivotal clinical study to demonstrate the safety and effectiveness of the MagicTouch PTA sirolimus-coated balloon in femoral and popliteal segments. Data generated from the clinical study will support a future pre-market approval application in the U.S.

MagicTouch PTA is a sirolimus-coated balloon that has had extensive commercial use in Europe, major markets of Asia and the Mid-Eastern markets.

Peripheral arterial disease affects an estimated quarter of a million adults in Europe …

Concept Medical this week announced that the FDA has granted an investigational device exemption (IDE) approval for its MagicTouch sirolimus-coated balloon (SCB).

The IDE approval covers the device for treating small vessels in coronary arteries. It was the third IDE approval for the company’s MagicTouch SCB. The IDE approval will allow Concept Medical to initiate a pivotal clinical study to support the safety and effectiveness of the device in small vessel coronary disease.

Along with the IDE approval for treating small vessels, Concept Medical also received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary in-stent restenosis indication and below-the-knee indication.

“The FDA-approval to initiate the MAGICAL-SV Clinical trial using the MagicTouch sirolimus-covered balloon with novel coating technology represents a landmark event in our decades-long quest to find an optimal therapy to manage pati…