News | Drug-Eluting Balloons | November 06, 2019

Safety and Efficacy Sustained Over Two Years in Selution Drug-eluting Balloon First-in-Human Trial

Novel sirolimus-eluting balloon two-year data from the SELUTION SFA Trial

The Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, #VIVA2019 #VIVA #VIVA19

November 6, 2019 – Positive, two-year data from the first-in-human study of Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, was presented at VIVA 2019 by Principal Investigator Professor Thomas Zeller, M.D., Ph.D., Universitaets-Herzzentrum, Bad Krozingen, Germany. The study involved 50 patients treated with the investigational device in lesions of the superficial femoral artery (SFA) and popliteal artery.

Excellent freedom from target lesion revascularization (TLR) was achieved through to two years in 87.5% of patients, with no primary TLR event observed after Month 11. These figures are low for a drug-eluting balloon First-in-Human study over this time period. There were no incidences of death or the need for minor and/or major amputations over this period. Improvements in Rutherford Classification, ABI and walking ability previously observed at one year were all maintained out to two years.   

“These two-year results from the Selution SLR First-in-Human study are very encouraging," Zeller said. “They are the first two year data for a balloon eluting either a limus drug or sirolimus and are confirmation that a sustained limus release eluting balloon is both safe and effective in the treatment of SFA lesions over a prolonged period."

 

Use of Sirolimus vs. Paclitaxel in Drug-coated Balloons

Historically, paclitaxel has been the drug of choice for use in drug-coated balloons (DCBs). The drawback of limus drugs compared with paclitaxel in DCBs has been the difficulty in transfer—because limus drugs have a relative lack of lipophilicity compared with paclitaxel, they have lower bioavailability when only short-term tissue contact is provided. The MedAlliance Selution SLR is based on microreservoir balloon coating technology, which provides controlled and sustained sirolimus release with a therapeutic effect for over 60 days. 

It uses a cell adherent technology is a proprietary amphiphatic lipid technology that binds microreservoirs to the balloon surface, and it contains and protects microreservoirs during insertion and inflation. Also, it facilitates higher drug transfer efficiency, allowing for low drug dose (1 µg/mm2) on the balloon surface, and maximizes the drug bioavailability.

Selution’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These provide controlled and sustained release of sirolimus. To date, extended release of sirolimus has only been demonstrated highly efficacious when delivered from stents. MedAlliance’s proprietary CAT (Cell Adherent Technology) coating enables the micro-reservoirs to be applied to balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.

 

Selution SLR First-in-Human Study

The study involved 50 patients enrolled across four German centers. Its objective has been to assess the safety and efficacy of Selution SLR in the treatment of lesions of the superficial femoral artery and/or the popliteal arteries, measured at multiple time points through clinical, duplex ultrasound and/or angiographic assessment (six-month time point only). The Selution SLR First-In-Human study was a prospective, controlled, multi-centre, open, single-arm clinical investigation. The primary endpoint of the study was angiographic late lumen loss (LLL) at six months. Secondary endpoints included major adverse events, primary patency, and angiographic binary restenosis. Primary endpoint data, first presented by Prof. Zeller at LINC in January 2018, demonstrated a LLL of 0.19 mm.

SELUTION SFA is a prospective, controlled, multicenter, open-label, single-arm clinical trial treating superficial femoral artery (SFA) lesions (lesion length, 51.3 ± 40.3 mm; 34% moderate-severe calcification). The trial enrolled 50 patients in four German centers between November 2016 and May 2017. Patients enrolled were symptomatic with de novo or restenotic lesions with ≥ 70% diameter stenosis or occlusion.

The primary endpoint was defined as late lumen loss (LLL) evaluated by angiography at 6 months. Duplex ultrasound and clinical endpoints were evaluated at 6, 12, and 24 months. Main secondary endpoints are primary patency, target lesion revascularization (TLR), change in Rutherford classification, and change in ankle-brachial index (ABI).

The SELUTION SFA trial met its primary endpoint and demonstrated an LLL of 0.19 mm. Excellent freedom from clinically driven TLR was achieved through 24 months in 87.5%, with no primary TLR event observed after month 11.

Clinical improvements were seen in Rutherford classification, ABI, and walking impairment at 6 months and were further improved to 12 months and maintained to 24 months. This initial first-in-human trial demonstrates that SELUTION SLR is a viable option to treat lesions in the SFA. It is the first demonstration of a sirolimus safety and efficacy in peripheral intervention.

MedAlliance said it anticipates receiving European CE mark market approval for the Selution SLR within the next few months.

For more information: http://medalliance.com/

Find information on all the VIVA 2019 Late-breaking Clinical Trials
 

Related Content

FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
Overlay Init