The breakthrough designation will enable the company to assist more patients with its robust drug delivery medical device.
FREMONT, CA: Concept Medical recently announced its breakthrough device designation by the FDA for the sirolimus-coated balloon. The MagicTouch PTA Sirolimus drug-coated balloon is designed for the treatment of peripheral artery disease below the knee. A clinical trial assessing the safety and efficacy of the device for the treatment of below the knee and femoropopliteal lesions is in progress. The company had received another FDA breakthrough designation in April for its sirolimus-coated balloon to treat coronary artery diseases in patients with in-stent restenosis.
Headquartered in Tampa, Florida, Concept Medical is a pioneer in the drug delivery medical devices industry. The company has offices in Singapore, the Netherlands, Brazil, and commercial sales in Europe, Asia, and the Middle East, among others. Concept Medical has a robust pipeline of products and clinical programs carried out in several countries.
The late mortality signals discovered by researchers and FDA specialists had led to the convention of an advisory panel, which recommended the agency to update device labels to warn the patients. It had led to a lag in the treatment of below the knee PAD using paclitaxel-coated devices.
If the FDA grants marketing authorization for Concept Medical’s sirolimus-coated device, it can achieve a significant market share from medtechs with paclitaxel devices including BD, Medtronic, Boston Scientific, Philips, and Cook Medical.
The breakthrough device designation will empower the company to interact more closely with the FDA reviewers employed to assess the device. The agency is likely to accept a greater extent of the uncertainty of the benefit risk-profile for devices if they present probable benefits to patients with earlier access to the devices. However, premarket approval has to be bolstered with adequate postmarket controls.
Concept Medical aims to assist PAD patients in averting amputations caused by critical limb ischemia through its robust offerings. The device will potentially revolutionize the sector, significantly enhancing treatment of peripheral artery disease below the knee.