First US Patient Enrolled in SELUTION SLR IDE Peripheral Study

GENEVA, Switzerland, Aug. 24, 2022 /PRNewswire/ — The first US affected person has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) scientific trial evaluating SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the primary affected person occurring in Germany one week after approval.  

“We are very excited to finally have drug-eluting technology in the US to treat this difficult patient population,” commented the trial’s Principal Investigator (PI) Dr. Ehrin Armstrong. “We are encouraged by the positive early outcomes with this novel SELUTION SLR Sirolimus Drug Eluting Balloon (DEB) in Europe and Asia. We hope this FDA IDE trial will demonstrate significant benefit for patients who currently have limited treatment options.”

The purpose of the SELUTION4BTK scientific trial is to reveal the superior efficacy and equal security of SELUTION SLR in comparison with plain (uncoated) balloon angioplasty (POBA) in the remedy of BTK arteries in Chronic Limb Threatening Ischemia (CLTI) sufferers. The trial is a potential, multi-center, single blinded, randomized research (ClinicalTrials.gov Identifier: NCT05055297).

377 topics are being randomized 1:1 to both SELUTION SLR or management remedy. This is the primary research of its type the place ‘actual world’ sufferers with CLTI could be included. Patients are being enrolled at roughly 40 websites throughout the US, Europe and Asia. This first US affected person was enrolled at Vascular Solutions in Cary, North Carolina by Dr. Siddhartha Rao.    

“We are very pleased to be participating in this groundbreaking study,” stated Dr Rao, “We hope that this promising technology will fulfill a huge need for our patients with chronic limb-threatening ischemia, saving life and limb. We look forward to the rapid enrolment of this trial.”

“We were the first company to be granted ‘Breakthrough Device Designation’ for a DEB by the FDA and are proud to enrol the very first US patient in a sirolimus DEB study,” added Jeffrey B. Jump, MedAlliance Chairman and CEO. “Many companies have been trying for years to bring sirolimus to the US and we are very pleased with our team for achieving this significant milestone. US patients will now have an alternative to paclitaxel DEB, addressing the concerns expressed by the FDA.”

SELUTION SLR was awarded CE Mark Approval for the remedy of peripheral artery illness in February 2020 and for the remedy of coronary artery illness in May 2020. The US FDA has awarded SELUTION SLR with 4 breakthrough designations: for the remedy of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.

In August 2021, the primary of over 3,000 sufferers was enrolled in a ground-breaking coronary randomized managed research evaluating SELUTION SLR with a limus drug-eluting stent (DES), powered to reveal superiority. SELUTION DeNovo is the most important DEB research ever initiated and has the potential to vary medical observe.

MedAlliance’s DEB expertise entails distinctive MicroReservoirs produced from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs present managed and sustained launch of the drug for as much as 90 days¹. Extended launch of sirolimus from stents has been confirmed extremely efficacious in each coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) permits the MicroReservoirs to be coated onto balloons and cling to the vessel lumen when delivered by way of an angioplasty balloon.

SELUTION SLR is accessible in Europe and all different international locations the place the CE Mark is acknowledged.

About MedAlliance

MedAlliance is a privately-owned medical expertise firm. It is headquartered in Nyon, Switzerland, with places of work in Germany, Singapore, UK and USA. MedAlliance specializes in the event of ground-breaking expertise and commercialization of superior drug system mixture merchandise for the remedy of coronary and peripheral artery illness. For additional data go to: www.medalliance.com

¹ Drug focus evident in MicroReservoirs and tissue – Data on file at M.A. Med Alliance SA

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Richard Kenyon

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