Med Alliance Release: Initial Patients Enrolled In First-in-Man Study Of Novel Sirolimus-Coated Balloon
1 November 2016 – Med Alliance has announced first patient enrolment in the First-in-Man (FIM) study of SELUTION™, a novel sirolimus-coated balloon. Patients were enrolled at the Universitaets-Herzzentrum, Bad Krozingen, Germany, and the Franziskus Krankenhaus, Berlin, Germany.
SELUTION contains micro-reservoirs made out of biodegradable polymer intermixed with sirolimus. The micro-reservoirs, which are unique to the SELUTION Drug-Coated Balloon (DCB), provide controlled and sustained release of the antirestenotic drug sirolimus, which is expected to provide a therapeutic effect in treating lesions over a prolonged period of time. This ground-breaking study is intended to demonstrate that SELUTION is the first DCB with sustained release of sirolimus.
“In pre-clinical studies, this technology has demonstrated sustained sirolimus release for several months. These findings gave us the confidence to initiate the FIM, whose results will permit comparison to previous studies of paclitaxel drug-coated balloons in the superficial femoral artery”, commented Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
“We are very excited to have enrolled the first patient in this important trial”, added Dr Ulrich Beschorner, Universitaets-Herzzentrum, Bad Krozingen, Germany. “Both I and my fellow investigators participating in this study are committed to supporting a rapid enrolment process”.
The objective of the FIM study is to assess the safety and efficacy of SELUTION in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral artery and/or the popliteal arteries, assessed at multiple time points through clinical, ultrasound and/or angiographic assessment. The SELUTION FIM Study will enrol 50 patients in a prospective, controlled, multi-centre, open, single-arm clinical investigation. The primary endpoint of the study is Angiographic Late Lumen Loss at six months. Secondary endpoints include Major Adverse Events, Primary Patency, and Angiographic Binary Restenosis.
“This FIM will pave the way for studies in other indications, such as Below the Knee (BTK) lesions, where a balloon coated with sirolimus may be safer and more effective than one coated with paclitaxel”, concluded Professor Zeller. “We are proud to have successfully achieved regulatory approval for this FIM study”, said Med Alliance Chairman Jeffrey B. Jump. “Enrolling these first patients is a significant milestone for the company”.
Enrolment in the SELUTION FIM study is scheduled for completion before summer 2017, with primary endpoint results anticipated in late 2017.
SELUTION is registered on clinicaltrials.gov, NCT02941224.
Founded in 2008, Med Alliance is a privately-owned medical technology company headquartered in Switzerland, with an R&D facility in Irvine, California. It contains a team of experienced professionals focused on patient benefit, with recognised track record of success in the conception, development and commercialisation of drug-eluting stents, balloons, polymers and drugs. The company is currently developing medical products for the treatment of coronary and peripheral artery disease.
SELUTION contains micro-reservoirs made out of biodegradable polymer intermixed with sirolimus. The micro-reservoirs, which are unique to the SELUTION Drug-Coated Balloon (DCB), provide controlled and sustained release of the antirestenotic drug sirolimus, which is expected to provide a therapeutic effect in treating lesions over a prolonged period of time. This ground-breaking study is intended to demonstrate that SELUTION is the first DCB with sustained release of sirolimus.
“In pre-clinical studies, this technology has demonstrated sustained sirolimus release for several months. These findings gave us the confidence to initiate the FIM, whose results will permit comparison to previous studies of paclitaxel drug-coated balloons in the superficial femoral artery”, commented Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
“We are very excited to have enrolled the first patient in this important trial”, added Dr Ulrich Beschorner, Universitaets-Herzzentrum, Bad Krozingen, Germany. “Both I and my fellow investigators participating in this study are committed to supporting a rapid enrolment process”.
The objective of the FIM study is to assess the safety and efficacy of SELUTION in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral artery and/or the popliteal arteries, assessed at multiple time points through clinical, ultrasound and/or angiographic assessment. The SELUTION FIM Study will enrol 50 patients in a prospective, controlled, multi-centre, open, single-arm clinical investigation. The primary endpoint of the study is Angiographic Late Lumen Loss at six months. Secondary endpoints include Major Adverse Events, Primary Patency, and Angiographic Binary Restenosis.
“This FIM will pave the way for studies in other indications, such as Below the Knee (BTK) lesions, where a balloon coated with sirolimus may be safer and more effective than one coated with paclitaxel”, concluded Professor Zeller. “We are proud to have successfully achieved regulatory approval for this FIM study”, said Med Alliance Chairman Jeffrey B. Jump. “Enrolling these first patients is a significant milestone for the company”.
Enrolment in the SELUTION FIM study is scheduled for completion before summer 2017, with primary endpoint results anticipated in late 2017.
SELUTION is registered on clinicaltrials.gov, NCT02941224.
Founded in 2008, Med Alliance is a privately-owned medical technology company headquartered in Switzerland, with an R&D facility in Irvine, California. It contains a team of experienced professionals focused on patient benefit, with recognised track record of success in the conception, development and commercialisation of drug-eluting stents, balloons, polymers and drugs. The company is currently developing medical products for the treatment of coronary and peripheral artery disease.