Florida healthtech firm Concept Medical has enrolled the first patient in its MAGICAL trial examining its sirolimus-coated balloon against traditional angioplasty for patients living with below-the-knee peripheral artery disease (PAD).
The announcement comes after the company secured an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) for the MagicTouch PTA. The company is launching two other trials examining its drug-coated alternative to standard percutaneous transluminal angioplasty (PTA).
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MagicTouch PTA is a sirolimus coated balloon catheter designed to widen and open the narrowed arteries to restore blood flow by delivering sirolimus drug at the target site.
The primary endpoint for the trial (NCT06182397) revolves around primary patency conducted at approximately 70 sites; 40 of which will be based in the US with a goal of recruiting at least 50% of trial participants from within the US.
Manish Doshi, founder and managing director of Concept Medical, said: “At Concept Medical, our unwavering commitment to innovation and patient care drives us to push the boundaries of what is possible in vascular interventions. The start of MAGICAL-BTK further validates our dedication to bringing next-generation, evidence-based solutions to clinicians and patients worldwide. Our goal is to redefine current standards, ensuring better outcomes and improved quality of life for those affected by PAD.”
The MAGICAL below-the-knee trial runs alongside two other trials, the MagicTouch PTA (NCT04368091) and the MagicTouch SCB trials examining the device in coronary artery disease and peripheral interventions respectively.
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By GlobalDataPrakash Krishnan, an investigator for the below-the-knee trial, said: “The enrolment of the first patient in the MAGICAL-BTK trial represents an important stride toward improving the standard of care for below-the-knee disease in patients with peripheral artery disease.
“Sirolimus-coated balloon technology has the potential to significantly enhance limb salvage and patient quality of life. I am honoured to be part of this landmark study and look forward to the meaningful clinical evidence it will generate.”
Research by GlobalData estimates that the global market for Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheters is set to be worth $1.7bn by the end of 2025, with that figure estimated to rise to $1.9bn by the end of 2030, growing at a comping annual growth rate (CAGR) of 2.88%.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of balloon angioplasty, Teleflex has been granted 510(k) clearance on its Ringer Perfusion Balloon Catheter (PBC) for PTCA. Meanwhile, Orchestra BioMed has announced plans to commence a study of its non-coated angioplasty system, Virtue Sirolimus AngioInfusion Balloon (SAB).
