Events 2019

MedAlliance leads US Sirolimus DEB race: First US Patient enrolled into SELUTION SLR Coronary Sirolimus DEB Study

25th January 2023 – The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US in October 2022. SELUTION SLR is the first sustained limus release coronary drug-eluting balloon (DEB) to receive FDA IDE approval for In-Stent Restenosis (ISR) indications.

“We are very excited to have enrolled our first US patient”, commented Dr Don Cutlip, Co-Principal Investigator of the IDE SELUTION4ISR Study and the Chief Medical Officer at Baim Institute for Clinical Research.  “This study  addresses the important unmet need of  treatment for the ongoing problem of in-stent restenosis without adding an additional layer of metal stent.”

“This is an exciting day for PCI in the USA. DEB is the standard of care for ISR around the world, with the exception of the US. Treating coronary ISR is challenging and having DEB technology made available through a well-designed and conducted randomized clinical trial is the next step. This trial is now underway and this is great for our patients!” added Co-Principal Investigator  Prof. Roxana Mehran, Mount Sinai Professor in Cardiovascular Clinical Research and Clinical Trials.

“This is another significant milestone for MedAlliance: we were the first sustained limus release balloon to receive FDA IDE approval, the first to treat a US peripheral patient and now the first to treat a US coronary patient.  This is the culmination of a multi-year R&D program that delivered comprehensive pre-clinical data meeting the very high standards of the US FDA”, added Jeffrey B. Jump, MedAlliance Chairman and CEO. “We are very pleased with the high level of market acceptance we are experiencing in Europe, Asia and South America, and we look forward to entering the US market following FDA approval”.

Enrollment of the IDE SELUTION4ISR FDA coronary study is ongoing outside the US and additional US centers will soon join Medstar after this first US enrollment. (ClinicalTrials.gov Identifier: NCT04280029).

MedAlliance received IDE approval for coronary de novo indications on Jan 6^th. The OUS SELUTION DeNovo study has more than 800 patients of the 3,326 enrolled in this ground-breaking coronary randomized study comparing treatment strategy with SELUTION SLR (DEB) vs. limus drug eluting stent (DES) strategy.

SELUTION SLR was awarded CE Mark Approval for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive FDA Breakthrough Designation status.  In addition to the BTK and superficial femoral artery (SFA) indications for which the company received FDA IDE approval in May and August 2022, MedAlliance received coronary in-stent restenosis (ISR) IDE approval in October 2022 and de novo coronary artery lesions on January 6^th 2023, which will complement the substantial experience that the company has gained with the SELUTION DeNovo trial in Europe.

MedAlliance’s unique DEB technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug “sirolimus” applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.

SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials. Please contact us if your centre is interested in participating in this study.

MedAlliance’s SELUTION SLR is the first DEB to receive coronary De Novo IDE approval, its fourth FDA IDE DEB Approval

January 10, 2023 – SELUTION SLR™ MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions.

This comes less than eight months after the company received its first IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications; as well as occlusive disease of the superficial femoral artery (SFA); and coronary In-Stent Restenosis (ISR).

Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.

This will complement the substantial experience that the company has already gained with the SELUTION DeNovo trial in Europe (ClinicalTrials.gov Identifier: NCT04859985). More than 800 patients of the 3,326 planned have been enrolled in this ground-breaking coronary randomized controlled study comparing SELUTION SLR vs. any limus drug-eluting stent (DES). The study is powered to demonstrate superiority of SELUTION SLR drug-eluting balloon (DEB) over DES in coronary de novo artery disease. This is the largest DEB study ever initiated and has the potential to change medical practice where implants (metal stents) have been the standard of care for more than 30 years.

“Treatment of de novo coronary arteries with drug-eluting balloons is a breakthrough in revascularization of coronary artery disease. The SELUTION SLR coronary de novo study is the first of its kind in the USA and will provide important data on the efficacy and safety of sirolimus- eluting balloon as a viable alternative to drug-eluting stent, leaving nothing behind post-PCI and eliminating in-stent restenosis and related complications,” said Dr. Ron Waksman, Professor of Cardiology at Georgetown University, Director of Cardiovascular Research at MedStar Heart and Vascular Institute, Washington DC  and Chairman of the MedAlliance Coronary Study Steering Committee.

“Coronary de novo lesions are the largest potential opportunity for use of DEB’s: the data has shown clearly that DES don’t work well in small vessels, long, or bifurcated lesions or in patients with diabetes or risk of high bleeding complications. These patients represent 60% of all patients currently treated with DES, who may now benefit from this exciting new DEB technology,” added Jeffrey B. Jump, Chairman and CEO of MedAlliance.

SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020.

MedAlliance’s unique DEB technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days.

SELUTION SLR 014 PTCA is commercially available in Europe, Asia, the Middle East and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 10,000 coronary units have already been used for patient treatment in routine clinical practice or as part of clinical trials.