Concept Medical Launches Study After FDA Grants Device IDE

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A new drug delivery technology is preparing for its first human patients.

Concept Medical announced that it is launching its IDE clinical study on its MagicTouch drug delivery system. According to a press release, the study, named Magical-ISR, began its patient enrollment at the AtlantiCare Institute in Atlantic City, New Jersey.

The MagicTouch is a drug coated balloon designed for the management of in-stent restenosis for patients with coronary artery disease. The goal of the current study is to test the safety and efficacy of the new technology. If the device works correctly, it will provide doctors with a way to provide patients with a controlled and sustained release of Sirolimus.

Concept Medical describes it as being similar to drug stent, although with the benefit of not requiring permanent scaffolds to be placed within the patient.

In a press release, study chair and founder of the Cardiovascular Research Foundation in New York Dr. Martin Leon said, “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.”

In the same press release Concept Medical’s founder and managing director Dr. Manish Doshi also said, “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."

Along with Dr. Martin Leon, Doctors Azeem Latib and Ajay J. Kirtane are running the study.

Earlier this month, Concept Medical announced that FDA had granted them an investigational device exemption (IDE) for the MagicTouch AVF.² This was the fifth IDE granted to the MagicTouch portfolio by FDA. This exemption granted Concept Medical the ability to begin studies on the device to test its safety and efficacy.

MagicTouch has also been granted breakthrough designation status by FDA.

In a press release issued at the time, Doshi said, “This approval is not just a testament to our relentless pursuit of innovation but also marks a pivotal moment in our journey to redefine the treatment landscape for haemodialysis patients. We look forward to MagicTouch AVF's positive impact on patient care and are excited about the upcoming clinical trials."

Sources

1. Concept Medical Announces Enrollment of First Patient in “Magical-ISR” IDE Study in the US. Concept Medical. April 19, 2024. https://www.prnewswire.com/news-releases/concept-medical-announces-enrollment-of-first-patient-in-magical-isr-ide-study-in-the-us-302122287.html
2. Concept Medical Receives US FDA IDE Approval for Magictouch AVF Indication, Their Fifth US Clinical Study Approval for the MagicTouch Portfolio. Concept Medical. April 2, 2024. Accessed April 19, 2024. https://www.prnewswire.com/news-releases/concept-medical-receives-us-fda-ide-approval-for-magictouch-avf-indication-their-fifth-us-clinical-study-approval-for-the-magictouch-portfolio-302105425.html