Concept Medical Launches Pioneering Clinical Study for PAD

Concept Medical Unveils New Trial for PAD Treatment

Concept Medical Inc., a leader in innovative drug delivery technology, proudly announces the first patient enrollment in its pioneering clinical study called the "MAGICAL BTK" trial. This pivotal trial seeks to enhance treatment options for individuals suffering from peripheral artery disease (PAD) below the knee.

Breakthrough Enrollment in Clinical Trial

The first patient was successfully enrolled by Dr. Prakash Krishnan and his team at the Icahn School of Medicine at Mount Sinai. This enrollment marks a significant step forward in the treatment landscape, providing hope for many affected by PAD.

Regulatory Approval and Clinical Program Launch

This milestone follows the recent Investigational Device Exemption (IDE) approval granted by the U.S. Food and Drug Administration (FDA) for the innovative MagicTouch PTA device. With this approval, Concept Medical's clinical trial program for PAD now commences, alongside ongoing studies investigating coronary artery disease treatments.

Significance of Sirolimus-Coated Balloons

Dr. Prakash Krishnan stated, "The enrollment of the first patient in the MAGICAL BTK trial signifies an important advancement towards improving care standards for below-the-knee disease in patients with PAD. Sirolimus-coated balloon technology has the potential to greatly improve limb salvage rates and the quality of life for patients." The trial's primary goal is to evaluate the safety and effectiveness of the MagicTouch PTA compared to traditional balloon angioplasty.

Notable Leadership and Research Collaboration

This global, multi-center study is spearheaded by Prof. Sahil Parikh, who is supported by an esteemed group of Principal Investigators including Dr. Eric Secemsky and Prof. Brian DeRubertis. Their collaboration emphasizes the seriousness and commitment to enhancing patient care in this area of vascular health.

Transforming PAD Treatment Paradigms

Prof. Parikh discusses the trial's significance, saying, "The MAGICAL BTK Trial heralds unprecedented hope for patients with chronic limb-threatening ischemia, aiming to mitigate the risks associated with insufficient blood circulation in their legs."

Advancing Innovative Technologies in Vascular Care

With prior success in large-scale trials for MagicTouch across regions such as Asia and Europe, U.S. patients can now benefit from this innovative therapy. Concept Medical's ongoing commitment to expanding patient enrollment beyond the U.S. further enhances the understanding of the technology's impacts on diverse populations.

A Vision for Next-Generation Solutions

Dr. Manish Doshi, the Founder and Managing Director of Concept Medical, emphasized the company's dedication to innovation, stating, "The start of the MAGICAL BTK trial showcases our pursuit of next-generation, evidence-based solutions for both clinicians and patients. Our aim is to redefine existing health standards to improve outcomes for people affected by PAD."

Conclusion: Transforming Endovascular Care

With both the MAGICAL BTK trial and upcoming MAGICAL SFA IDE trial focused on superficial femoral artery treatment, Concept Medical is set to transform the landscape of endovascular care. Their proprietary technology continues to have a meaningful impact on the management of vascular diseases, with the commitment to effective, drug-delivery solutions exemplified through the MagicTouch family.

About Concept Medical

Concept Medical Inc. is based in Tampa, Florida, and strives to improve patient care through groundbreaking research and development of drug-delivery technologies. The company is well-known for its versatile and effective MagicTouch family of Sirolimus Coated Balloons (SCBs), which have established a new standard in treating coronary and peripheral artery disease. Having treated over one million patients globally, their technologies are reshaping the approach to vascular therapy.

Frequently Asked Questions

What is the MAGICAL BTK trial?

The MAGICAL BTK trial is a pivotal study evaluating the effectiveness of the MagicTouch PTA Sirolimus Coated Balloon compared to standard angioplasty treatments for below-the-knee arterial disease.

Who is leading the MAGICAL BTK trial?

The trial is led by Prof. Sahil Parikh, supported by a distinguished panel of principal investigators from renowned institutions.

What are the expected outcomes of the trial?

The primary endpoint is to evaluate the safety and effectiveness regarding primary patency at 12 months, which focuses on meaningful clinical outcomes for patients.

How does Sirolimus-coated balloon technology benefit patients?

This technology aims to enhance limb salvage rates and improve patients' quality of life by providing more effective treatment options for PAD.

What is Concept Medical's mission?

Concept Medical's mission is to innovate and develop drug delivery technologies that improve vascular care standards, ultimately benefiting patients worldwide.

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