Concept Medical, a pioneer in innovative drug delivery technologies, is proud to announce the initiation of its groundbreaking IDE clinical trial, “MAGICAL-ISR,” aimed at treating intrastent restenosis (ISR) in coronary artery disease. The trial utilizes the innovative MagicTouch: sirolimus drug-coated balloon (DCB) for the treatment. The first patient enrollment took place at the AtlantiCare Institute in Atlantic City, New Jersey, under the supervision of Dr. Said Ashraf and his team.
The MAGICAL-ISR study aims to evaluate the safety and efficacy of Sirolimus DCB in treating ISR, specifically focusing on the proportion of patients who avoid target lesion failure (TLF) within one year after the procedure. Esteemed physicians Dr. Martin Leon, Dr. Azeem Latib, and Dr. Ajay J. Kirtane are leading the study.
MagicTouch represents a revolutionary advancement in coronary intervention by offering controlled and sustained release of Sirolimus, similar to a drug-eluting stent without the need for a permanent implant.
“We are thrilled to announce the first enrollment in the MAGICAL-ISR study, featuring the MagicTouch Sirolimus drug-coated balloon technology. This groundbreaking clinical trial will usher in an era of safe and effective DEB therapy in a variety of clinical and anatomical circumstances to complement and enhance the treatment of complex obstructive coronary disease for our patients in the United States,” expressed Dr. Martin Leon, the study’s lead investigator and founder of the Cardiovascular Research Foundation (CRF).
Dr. Manish Doshi, the founder and CEO of Concept Medical, added, “The MagicTouch technology has been globally adopted, and its entry into the US market through this study represents a crucial step in addressing unmet needs in ISR treatment. Our commitment to innovation and patient safety is unwavering, and we anticipate that this study will have a significant impact on how ISR is treated worldwide.”
Concept Medical has set a benchmark with MagicTouch, the world’s first sirolimus drug-coated balloon, which has been widely adopted internationally and awarded FDA Innovation Designation status. The MAGICAL-ISR study, along with other ongoing IDE clinical trials, underscores the company’s dedication to clinical excellence and innovation.
About Concept Medical:
Concept Medical, headquartered in Tampa, Florida, with global presence, is dedicated to enhancing patient care through innovative research and development of drug delivery technology for vascular and non-vascular diseases. They use a unique combination of patented coating technology and products that deliver pharmaceutical agents through the luminal surfaces of blood vessels. Concept Medical is the creator of MagicTouch, the world’s first and most utilized sirolimus-coated balloon, with presence in Europe, Asia, Latin America, the Middle East, and all other regions where the CE mark is recognized.
Concept Medical’s revolutionary technology, including the innovative MagicTouch and Abluminus products, has been used in the treatment of over 500,000 patients worldwide for cardiovascular treatments.
For more information about the MAGICAL-ISR study or Concept Medical’s innovative solutions, please visit www.conceptmedical.com.
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Concept Medical, a pioneer in innovative drug delivery technologies, has launched a groundbreaking clinical trial called “MAGICAL-ISR” to combat intrastent restenosis (ISR) in coronary artery disease. The trial utilizes the MagicTouch: sirolimus drug-coated balloon (DCB) for treatment. The study aims to evaluate the safety and efficacy of Sirolimus DCB in treating ISR, specifically focusing on the proportion of patients who avoid target lesion failure (TLF) within one year after the procedure. The trial is being led by esteemed physicians Dr. Martin Leon, Dr. Azeem Latib, and Dr. Ajay J. Kirtane.
One advantage of the MagicTouch technology is its ability to offer controlled and sustained release of Sirolimus, similar to a drug-eluting stent, without the need for a permanent implant. This advancement in coronary intervention has the potential to enhance the treatment of complex obstructive coronary disease.
Concept Medical has already achieved success with MagicTouch, the world’s first sirolimus drug-coated balloon, which has been widely adopted internationally and awarded FDA Innovation Designation status. The initiation of the MAGICAL-ISR study in the United States represents a significant step in addressing unmet needs in ISR treatment.
However, there are several challenges and controversies associated with this subject. One challenge is the need to demonstrate the long-term safety and efficacy of Sirolimus DCB compared to other treatment options for ISR. This clinical trial will provide valuable data in this regard. Additionally, there may be skepticism or resistance from healthcare providers or regulatory bodies about adopting new technologies and treatments without a substantial body of evidence.
In terms of market trends, the demand for innovative drug delivery technologies in the field of cardiovascular medicine is growing. With the increasing prevalence of coronary artery disease and the need for effective and safe treatment options, there is a strong market potential for Concept Medical’s MagicTouch technology.
Forecasts suggest that if the MAGICAL-ISR study demonstrates positive results, it could lead to wider adoption of Sirolimus DCB as a treatment option for ISR. This would not only benefit patients but also create a significant market opportunity for Concept Medical.
For more information about the MAGICAL-ISR study or Concept Medical’s innovative solutions, please visit Concept Medical’s official website: www.conceptmedical.com. The website provides detailed information about Concept Medical, their research and development efforts, and their patented drug delivery technology for vascular and non-vascular diseases.