USFDA IDE approval allows the investigational device to be used in a clinical study to prove the safety and effectiveness of the device
Medtech company, Concept Medical has announced receiving U.S. Food and Drug Administration (FDA)’s Investigational Device Exemption (IDE) approval for its sirolimus coated balloon- MagicTouch for Coronary Artery Diseases.
USFDA IDE approval allows the investigational device to be used in a clinical study to prove the safety and effectiveness of the device. These clinical studies are conducted to support a Pre-Marketing Authorisation (PMA) by the USFDA.
The U.S. currently follows conventional PCI, which uses stents, and since the newer generation of interventionalists and modern-day PCI are leaning towards drug-coated balloons, considering neither the operator nor the patient would prefer having a permanent metal implant, this moment will be a gamechanger for the fraternity as well as for the company.
Concept Medical raised funds for the IDE in 2018, and the SCB has so far received two breakthrough device designations and the IDE title to add to it. The IDE approval has been granted for In-Stent Restenosis (ISR), which will help the company to study the device in this indication in the US population.
Company’s MagicTouch SCB is currently the most clinically studied SCB, with more than 7000 patients. It has also designed two clinical studies which will soon start enrolling patients in the USA, apart from the already submitted strong pre-clinical and clinical evidence from multiple studies to the FDA.