Business Wire

FL-CONCEPT-MEDICAL-INC

Share
Concept Medical Granted “Breakthrough Device Designation” by FDA for MagicTouch PTA Sirolimus Coated Balloon

Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK).

Concept Medical Inc. is backed by cardiologist, philanthropist and serial entrepreneur Dr. Kiran Patel, a staunch supporter of innovative and disruptive medical devices, providing breakthrough treatments to the people of the world. Under the leadership of drug delivery pioneer Dr. Manish Doshi, the company has initiated an extensive range of worldwide clinical programs to create evidence for its innovative drug delivery devices.

Concept Medical Inc has pioneered the Sirolimus drug delivery platform technology (Nanolute Technology) which has a proven commercial history in the coronary applications in more than 30,000 patients worldwide. MagicTouch PTA Sirolimus coated balloon is developed using this Nanolute Technology for use in PAD.

In an ongoing clinical study (XTOSI), Associate Professor Edward CHOKE, Principal Investigator of the study and Chief of Vascular Surgery, Sengkang General Hospital, Singapore, said, “study is the world’s first pilot study to investigate the safety and efficacy of novel MagicTouch PTA Sirolimus drug coated balloon (SCB) in the treatment of below the knee arterial lesions in addition to femoropopliteal lesions. The majority of patients enrolled had major comorbidities (diabetes and end stage renal failure) and the indication for angioplasty was for severe critical limb ischemia (more than 90% had the most severe Rutherford scores of 5 or 6). The extent of peripheral arterial disease treated were also severe, and about 80% of patients did not have any patent below the knee arteries before angioplasty. I am very encouraged by the excellent results so far in these challenging cohort of patients. Device and technical success were both 100%. Freedom from device and procedure related mortality was 100%. Limb salvage rate at 30 days was 97%. At 6 months, freedom from clinically driven target lesion revascularization (TLR) was 91%; and primary patency, independently and blindly assessed by duplex ultrasound, was 82%. I did not encounter any distal embolization or 'slow flow phenomenon' after application of SCB in BTK vessels.”

Dr. Sahil PARIKH, an interventional cardiologist and Associate Professor of Medicine and Director of Endovascular Services at the Columbia University College of Physicians and Surgeons, said, “The breakthrough designation demonstrates how important it is for us to have new technologies for BTK intervention. Patients with Critical Limb Ischemia (CLI) represent an enormous burden to our healthcare system and comprehensive care for these patients begins with effective revascularization. The MagicTouch PTA will hopefully bring us closer to our goals of reducing amputations in the US and the world.”

Peripheral vascular disease is a circulatory problem in which the peripheral blood vessels – usually the arteries of the legs – are starved of blood supply due to narrowing, blockage or spasm of the supplying blood vessels. If peripheral vascular disease (PVD) occurs only in the arteries, it is called peripheral artery disease (PAD). Most of the times PAD results from narrowing of the lumen of the blood vessels caused by inflammation, plaque buildup, or tissue damage. Diabetes is a major risk factor for PAD - more than 85% of patients with diabetes will develop PAD in their lifetime. CLI is a manifestation of peripheral arterial disease that occurs as chronic ischemic rest pain or ischemic skin lesions, ulcers, or gangrene. Infra-popliteal or below-the-knee (BTK) atherosclerotic arterial disease, either alone or combined with aortoiliac and femoropopliteal vascular disease, is the leading cause of critical limb ischemia and resultant amputations. Peripheral Arterial Disease (PAD) affects over 8 million people in the United States alone.

The breakthrough device designation granted to MagicTouch PTA offers Concept Medical Inc. 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, which 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. The first ‘Breakthrough Device Designation’ received by Concept Medical Inc. was on 30th April 2019 for its MagicTouch SCB , for the treatment of Coronary Artery Disease (CAD) in patients with in-stent restenosis.

Link:

ClickThru

Social Media:

https://www.facebook.com/conceptmedicals

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Hoffmann Green Announces a Historic Increase in Production Over the First Half of 2025, Already Outperforming the Annual Volumes Realized in 20242.7.2025 19:05:00 CEST | Press release

Record activity levels: +151% increase in production volumes in H1 2025 vs. H1 2024More than 130 construction sites supplied with more than 60,000 m³ of 0% clinker concrete delivered by 10,000 truck mixers across the countryAcceleration driven by a strengthened partnership network and the successful diversification of targeted marketsSolid outlook for the second half of 2025, in line with the strategic roadmap Hoffmann Green Cement Technologies (ISIN: FR0013451044, Ticker: ALHGR) (“Hoffmann Green Cement” or the “Company”), an industrial player committed to the decarbonation of the construction sector that designs and markets innovative clinker-free cements, today announces a strong acceleration of production over the first half of 2025, validating the relevance of its industrial and commercial business model. Production volumes reached 19,640 tonnes over the first half of 2025, compared with 7,833 tonnes in the first half of 2024, representing a 2.5-fold increase. This very strong leve

Institutional Real Estate, Inc. Announces Acquisition of U.K.-based Lyndon Publishing 2 Limited2.7.2025 18:44:00 CEST | Press release

Institutional Real Estate, Inc. (“IREI”) has completed its acquisition of the assets of London-based Lyndon Publishing 2 Ltd (“Lyndon Publishing”), which include The Property ChronicleandThe Green Chronicle.The former Lyndon Publishing 2 will now operate as a division of IREI. The Property Chronicle reaches a global audience of real estate investment professionals, researchers, and academics. Its sister publication, The Green Chronicle, is edited to address the interests and concerns of emerging young talent in these real estate professions. Both publications are produced as weekly news briefings filled with original content and contributed feature articles from industry thought and opinion leaders. In addition, The Property Chronicle is also published as a quarterly, illustrated full-color magazine available in both digital and print formats, while The Green Chronicleis published exclusively in digital format. Together, the two publications reach approximately 50,000 professionals acr

Sinopec Wins Technological Innovation Award at 2nd Sino-European Corporate ESG Best Practice Conference2.7.2025 18:21:00 CEST | Press release

China Petroleum & Chemical Corporation ("Sinopec", HKG: 0386) has won the "Best Scientific and Technological Innovation Practice" award at the 2nd Sino-European Corporate ESG Best Practice Conference (the "Conference") on June 26 in Stuttgart. Sinopec’s case submission of Breakthrough in Depth, Climb to New Heights — Empowering the Energy and Chemical Industry with Technological Innovation stood out among numerous entries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702387465/en/ Wang Tao, Sinopec representative, delivered a speech at the conference. The Conference reviews and awards the best ESG application cases in six areas of environmental protection, social responsibility, corporate management, scientific and technological innovation, education, and training to further enhance mutual understanding between Chinese and European businesses, facilitate bilateral economic and trade exchanges, and showcase China’s open,

Xsolla Releases Their Q2 2025 The State of Play Report: Mobile Gaming Is Projected to Hit $126B in 2025 Amid Global App Boom With In-Depth Analysis of Trends, Genres, and Monetization Strategies2.7.2025 18:00:00 CEST | Press release

Key Topics Include In-App Purchase Trends, Genre Performance, Player Demographics, D2C Strategy Adoption, and Hybrid Monetization Models Xsolla, a leading global video game commerce company, proudly announces the release of the Q2 2025 Edition of “The Xsolla Report: The State of Play.” This detailed report provides crucial insights, trends, and opportunities shaping the gaming landscape, empowering industry professionals to adapt and thrive in today’s rapidly changing market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702208715/en/ Graphic: Xsolla In 2024, global mobile app usage soared to an astonishing 4.2 trillion hours, an all-time high that powered a massive $150 billion consumer spending across mobile platforms. Mobile gaming is leading this charge, which accounted for more than half of that total. Despite a 6% dip in overall game downloads, falling to 49.6 billion, in-app purchase (IAP) revenue surged, indicati

LambdaTest Announces Deeper Collaboration with Appium as Strategic Partnership2.7.2025 17:00:00 CEST | Press release

Move to accelerate mobile test automation at scale with LambdaTest’s expansive real device cloud, delivering unmatched accuracy, speed, and global reach. LambdaTest, a unified agentic AI and cloud engineering platform, has announced it has become a strategic sponsor of Appium, the world’s most widely used open-source framework for mobile automation. This collaboration aims to significantly simplify and accelerate mobile test automation by integrating Appium’s capabilities into LambdaTest’s cloud-based distributed testing platform. LambdaTest has an active open-source program that provides access to LambdaTest’s testing infrastructure to community projects, so maintainers can run comprehensive test suites without worrying about servers or setup. The organization had also launched LambdaTest Grants for Open Source to support innovation in software testing frameworks and toolsets. As part of the Grants, LambdaTest had announced a $250,000 grant for open source projects and contributors bu

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye