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Concept Medical Completes Patient Recruitment for the SirPAD Trial

Concept Medical Inc. (CMI), a leader in innovative drug delivery technologies for vascular interventions, recently announced the successful completion of patient recruitment for the SirPAD study, which has now enrolled over 1,250 patients.

The SirPAD clinical trial is a randomized controlled study examining serious adverse events in patients with femoro-popliteal and below-the-knee peripheral artery disease (PAD) treated with either sirolimus-coated or uncoated balloons. This trial is considered the world’s largest study evaluating the treatment of PAD using the MagicTouch PTA ballons from Concept Medical, setting it apart as one of the largest device studies ever conducted in this field.

Over the next year, these enrolled patients will be followed up to assess the primary endpoint concerning major adverse limb events (MALE) with final results expected in the first or second quarter of 2026. The trial is multicenter, investigator-initiated, and open-label, aiming to determine whether the MagicTouch PTA balloon with sirolimus coating is non-inferior to traditional balloon angioplasty (POBA), while also exploring the possibility of its superiority.

Leading researchers Prof. Dr. Nils Kucher and Prof. Dr. Stefano Barco from the University Hospital Zurich have emphasized the importance of sirolimus-coated balloons as a promising technology for treating symptomatic PAD, primarily supported by studies using surrogate endpoints. While studies like SIRONA and the ongoing SirPAD aim to enhance knowledge in this area, robust data derived from randomized controlled trials with clinical outcomes is essential for guiding treatment and shaping future guidelines.

The successful recruitment of over 1,250 patients marks a significant milestone for the SirPAD study. As sirolimus-coated balloons gain traction globally, the MagicTouch PTA is poised at the forefront of advancing the evidence supporting treatment options for PAD. With limited therapeutic choices currently available to patients, the aim of the SirPAD trial is to bolster the data supporting sirolimus-coated balloon technology. This comprehensive RCT plays a critical role in assessing alternatives for treatment, with the one-year follow-up expected to provide vital insights.

Dr. Manish Doshi, founder and CEO of Concept Medical, highlighted the company's commitment to providing solid clinical evidence for their innovative technologies. Following the successful completion of SIRONA, which was the largest study for superficial femoral artery (SFA) treatment comparing their device with paclitaxel-coated balloons (DCBs) showing no inferiority, CMI is delighted to announce the termination of recruitment for this momentous trial. CMI maintains its leadership with the most extensive and advanced clinical trial program in this arena, strengthening its status as a global pioneer in patient-centered vascular innovations.

Background on Concept Medical

Concept Medical Inc., headquartered in Tampa, Florida, is dedicated to improving patient care through cutting-edge research and development of drug delivery technologies. Pioneering proprietary platforms have been designed for the precise delivery of pharmaceutical agents across vascular luminal surfaces. The company is recognized for developing the MagicTouch family of sirolimus-coated balloons, known as the world’s first and most widely used sirolimus-coated balloon technology. Their innovative product lines, including MagicTouch and Abluminus, have already been utilized in more than a million patients globally, establishing a new benchmark in vascular therapy.

For more information, visit Concept Medical.