Concept Medical Inc (CMI) Receives Medical Device Product Status in Clinical Trials Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) on February 9, 2023 for Magic Touch sirolimus-coated balloon.
The Magic Touch PTA sirolimus drug coated balloon catheter is indicated for the treatment of atherosclerosis below the knee (BTK) in people with peripheral arterial disease. It is approved by the CMI Awarded IDE status first to the balloon-encased Sirolimus MagicTouch layer in September 2022 for the treatment of in-stent recurrent stenosis (ISR) PTA also received Breakthrough Device Status approval from the US Food and Drug Administration. to treat the symptoms below the knee as well
Non-invasive balloon angioplasty (POBA) is the standard technique for treating below-knee embolism. as well as a few balloons coated with approved paclitaxel. same as coil The IDE status approval allows Concept Medical to gather safety and efficacy data on Sirolimus Magic Touch’s PTA-coated balloon for pre-market approval (PMA) in the US As a result, from patients and doctors more options to treat artery disease below the knee.
The Sirolimus Magic Touch PTA drug eluted balloon catheter is CE certified and has been studied in multiple clinical trials outside the United States. It has shown promising results in terms of safety and efficacy. The product is currently being studied in Europe in two randomized controlled trials (RCTs) evaluating its potential for below-the-knee treatment. these include the LIMES RCT, a study designed to compare the efficacy of a Sirolimus MagicTouch PTA drug-coated balloon catheter with an uncoated balloon, and the BTK Duell Debate project compared with a PAC drug-coated balloon catheter.
Professor Sahil Parikh of Irving Medical Center “Concept Medical’s proposed clinical trial to study the effectiveness of PTA Magic Touch in the treatment of symptoms below the knee It gathers important information about the safety and performance of this device. to pave the way for treating patients in the United States Sirolimus Drug-Layered Balloon Approved for IDE Status in Coronary Artery Treatment and Status of an innovative device to treat many symptoms. As with much of the clinical data outside the US, “This will certainly make the device an eye-catcher among physicians and patients of peripheral arterial disease in the US.”
Professor Edward Choke, Sengkang General Hospital, Singapore One of the first researchers to study the Magic Touch PTA sirolimus coating balloon and is believed to have the most extensive experience with the device. An RCT called FUTURE BTK is now underway to study the results compared to an uncoated balloon. This project is an exciting phase 3 research. This will assess whether a PTA-coated sirolimus magic touch balloon will maintain the opening rate of dilated below-the-knee coronary arteries. Compared to the current standard as uncoated balloons This is a key goal in our efforts to reduce the likelihood of repeat operations. And helping patients with peripheral artery disease with the most severe symptoms does not require amputation. and if successful This has the potential to change the world.”
About Magic Touch PTA
Magic Touch PTA is a commercially available xylolimus coated balloon. It was developed using proprietary Nanolute technology. Nalolute is PTA’s Magic Touch balloon drug delivery technology platform. to reach the deepest layer of the vascular wall
Information about Concept Medical, Inc.
CMI is headquartered in Tampa, Florida, with operations in the Netherlands, Singapore and Brazil, and a manufacturing unit in India. and has a unique patented technology platform. and can be used to deliver any drug/pharmaceutical for vascular intrusion surfaces.
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