Gujarat-based multinational medical devices company, Concept Medical, has achieved a significant milestone by securing its fourth Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (USFDA). The approval is specifically for their revolutionary product, the MagicTouch Sirolimus Coated Balloon, which is designed to treat Superficial Femoral Arteries (SFA).
Concept Medical has already garnered three pivotal IDE approvals for its SCB Magic Touch family of products, catering to various medical conditions such as coronary In-Stent Restenosis (ISR), Coronary Small Vessel, and Below-the-Knee indications. Now, with the fourth IDE approval, the company aims to revolutionize the treatment of SFA disorders, bringing about significant improvements in patient outcomes.
Lower extremity Peripheral Arterial Disease (PAD) affects an estimated quarter of a million adults in Europe and North America, and it is associated with considerable morbidity and mortality, primarily caused by atherosclerosis. Stenosed and occluded Superficial Femoral Arteries play a major role in contributing to PAD. In this context, the MagicTouch PTA emerges as a groundbreaking innovation—the world’s first Sirolimus-coated balloon, already gaining widespread commercial usage in Europe, major Asian markets, and the Middle Eastern markets.
The IDE approval now granted to Concept Medical will enable the company to commence a clinical study, aiming to establish the safety and effectiveness of the MagicTouch PTA Sirolimus-coated balloon in the femoral and popliteal segments. The data generated from this IDE clinical study will provide crucial support for a future pre-market approval (PMA) application in the United States. Ultimately, this will pave the way for making the MagicTouch accessible to patients in need within the country.
Expressing his delight, Manish Doshi, MD of Concept Medical, stated, “We are very delighted to have received the 4th IDE clearance from the USFDA for MagicTouch PTA in the SFA indication.” This approval not only underscores Concept Medical’s commitment to innovation and advancing medical technology but also signifies a major step forward in improving the lives of patients suffering from SFA disorders.
Building upon the success of its previous IDE approvals for the SCB Magic Touch family of products, which target coronary In-Stent Restenosis (ISR), Coronary Small Vessel, and Below-the-Knee indications, Concept Medical continues to make remarkable strides in revolutionizing medical treatments. By obtaining the fourth IDE approval, the company is poised to bring about transformative changes in the treatment of SFA disorders, thereby significantly improving patient outcomes and quality of life.
The prevalence of lower extremity Peripheral Arterial Disease (PAD) remains a pressing concern, affecting an estimated quarter of a million adults across Europe and North America. This condition is associated with substantial morbidity and mortality, primarily caused by atherosclerosis. Stenosed and occluded Superficial Femoral Arteries play a crucial role in contributing to the development and progression of PAD. Recognizing this urgent medical need, Concept Medical’s MagicTouch PTA emerges as a groundbreaking innovation—a Sirolimus-coated balloon that has already gained widespread commercial usage in Europe, key Asian markets, and the Middle Eastern markets.
The recent IDE approval granted to Concept Medical is a significant milestone that enables the company to initiate a comprehensive clinical study. This study aims to demonstrate the safety and effectiveness of the MagicTouch PTA Sirolimus Coated Balloon in treating femoral and popliteal segments. The data generated from this IDE clinical study will serve as vital support for Concept Medical’s future pre-market approval (PMA) application in the United States. Ultimately, this will pave the way for the MagicTouch to be accessible to patients in need within the country, providing them with a highly advanced and effective treatment option for SFA disorders.
With Concept Medical’s groundbreaking MagicTouch Sirolimus Coated Balloon, medical professionals and patients alike can look forward to a new era of effective and advanced treatment options for Superficial Femoral Arteries. The company’s dedication to research, development, and regulatory compliance positions it at the forefront of the medical device industry, driving positive change and making a significant impact on patient care and outcomes.
