MedAlliance today touted late-breaking clinical trial data demonstrating positive outcomes with its Selution SLR drug-eluting balloon.
The company presented 18-month results from its Prestige below-the-knee (BTK) study evaluating the safety and performance of Selution SLR in treating long tibial occlusive lesions (TASC C & D) in patients with critical limb ischemia (CLI) at VIVA21.
According to a news release, 88% of patients exhibited freedom from target lesion revascularization (TLR), while 79% demonstrated amputation-free survival (AFS). The rate of wound healing was 79%, while 79% of patients improved their Rutherford score by at least one category as the 18-month results were sustained from the six-month and 12-month data.
Prestige, a prospective, single-center, physician-initiated clinical study at the Singapore General Hospital, enrolled 25 patients with an average age of 64, with 88% having diabetes mellitus and 44% having end-stage renal failure.
“We are very pleased with the 18-month BTK results in this very difficult patient population,” MedAlliance chairman and CEO Jeffrey B. Jump said in the release. “This complements the excellent results we have seen in SFA, AVF and coronary patients.”
Selution SLR includes unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
The platform currently has CE mark approval for treating peripheral artery disease (PAD) and holds four FDA breakthrough device designations for treating atherosclerotic lesions in innate coronary arteries, coronary in-stent restenosis, peripheral diseases below the knee and indications for arteriovenous fistula.
In August, the company closed enrollment for the Prestige clinical trial for treating patients with disease below the knee. Five days after that, MedAlliance enrolled the first patient in an erectile dysfunction (ED) feasibility study using Selution SLR. Last month, MedAlliance completed enrollment for a Japanese trial of Selution SLR in treating superficial or popliteal femoral artery lesions.