TAMPA, Fla., April 19, 2024 /PRNewswire/ -- Concept Medical, a
pioneer in innovative drug delivery technologies, proudly announces
the commencement of its groundbreaking IDE clinical study,
"MAGICAL-ISR" using MagicTouch – Sirolimus drug coated balloon
(DCB), for the management of in-stent restenosis (ISR) in coronary
artery disease. MagicTouch in ISR indication, had earlier been
granted a 'Breakthrough Device' designation& later the
Investigational Device Exemption (IDE)approval by the US FDA. The
first patient enrollment was done at the AtlantiCare Institute,
Atlantic City, NJ, by Dr
Said Ashraf (MD - Interventional
Cardiology) and team.
The MAGICAL-ISR study aims to assess the safety and
efficacy of this Sirolimus DCB in treating ISR, focusing on the
proportion of patients avoiding Target Lesion Failure (TLF) within
one-year post-procedure. The study was initiated under the guidance
of esteemed physicians Dr Martin
Leon, Dr Azeem Latib and Dr
Ajay J. Kirtane.
MagicTouch represents a revolutionary advancement in coronary
intervention, offering a controlled and sustained release of
Sirolimus, akin to a drug-eluting stent but without the necessity
of implanting permanent scaffold.
"We are thrilled to announce the first enrollment of the
MAGICAL-ISR study featuring the MagicTouch Sirolimus drug-eluting
balloon technology. This momentous clinical trial will herald
an era of safe and efficacious DEB therapy under a variety of
clinical and anatomic circumstances to complement and improve the
management of complex obstructive coronary disease for our patients
in the United States." expressed
Dr Martin Leon, Study Chair and
Founder of Cardiovascular Research Foundation (CRF), New York.
Dr Manish Doshi, Founder &
Managing Director of Concept Medical added, "The MagicTouch
technology has been embraced globally, and its entry into the US
market through this study, represents a critical step towards
addressing the unmet needs in ISR treatment. Our commitment to
innovation and patient safety is unwavering, and we anticipate this
study will significantly impact 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 honoured with the FDA's Breakthrough
Designation status. The MAGICAL-ISR study, alongside other ongoing
IDE clinical studies, underscores the company's dedication to
clinical excellence and innovation.
About Concept Medical:
Concept Medical is headquartered in Tampa, Florida, with a global presence. CM is
dedicated to enhancing patient care through innovative research and
development of drug delivery technology for vascular and
non-vascular diseases, utilizing a unique combination of technology
and products with proprietary coating technology that delivers
pharmaceutical agents across the luminal surfaces of blood vessels.
Concept Medical is the creator of MagicTouch, the world's first and
most utilized Sirolimus Coated Balloon, with a presence in
Europe, Asia, Latin
America, the Middle East,
and all other regions globally where the CE Mark is recognized.
Concept Medical's revolutionary technology, featuring
breakthrough products MagicTouch and Abluminus combined, has been
utilized in treating over 500,000 patients worldwide for
cardiovascular treatment.
For more information on the MAGICAL-ISR study or Concept
Medical's innovative solutions, please visit
www.conceptmedical.com.
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