Enrollment Begins in REMEDEE Trial of OrbusNeich's Combo DES

December 1, 2009—OrbusNeich, Inc. (Fort Lauderdale, FL) announced the initiation of patient enrollment in the REMEDEE (Randomized Evaluation of an Abluminal Sirolimus-Coated Bio-Engineered Stent) clinical trial of the company's Combo bioengineered sirolimus-eluting stent. REMEDEE is a prospective, randomized, multicenter study that will enroll 180 patients at up to 20 sites in Asia, Australia, Europe, and South America. Interventional cardiologists Ian T. Meredith, MBBS, PhD; Stephan Windecker, MD; and Alexandre Abizaid, MD, PhD, are REMEDEE's principal investigators.

According to the company, the primary objective is to demonstrate the safety and effectiveness of the Combo stent compared to the Taxus Liberté paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA) in the treatment of single de novo native coronary lesions ranging in diameter from ≥ 2.5 to ≤ 3.5 mm with lengths ≤ 20 mm.

The study population will consist of patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. REMEDEE's primary endpoint is in-stent late lumen loss of the Combo stent compared to the Taxus at 9 months postprocedure. Secondary endpoints include rates of all-cause and cardiac mortality, myocardial infarction, major adverse cardiac events, and stent thrombosis rates at 30 days, 9 months, and 1 through 5 years, as well as clinically driven target lesion revascularization (TLR), target vessel revascularization (TVR), and target lesion failure (TLF) rates at the same follow-up times.

The company stated that the Combo stent is designed to combine the prohealing technology used in OrbusNeich's Genous bioengineered R stent for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. The low-dose sirolimus elution is accomplished through the use of the SynBiosys biodegradable polymer matrix (SurModics, Inc., Eden Prairie, MN).

“The preclinical work has shown the effectiveness of combining the endothelial progenitor cell capture technology to promote endothelialization with the low-dose, abluminal, sirolimus elution to regulate hyperplasia,” commented Dr. Meredith. “The Combo stent could be the best of both world's approach for patients at the highest risk of restenosis.”

Renu Virmani, MD, President and Medical Director of CVPath Institute in Gaithersburg, Maryland, stated, “The Combo stent has demonstrated significantly lower neointimal hyperplasia, improved endothelial coverage relative to commercially available drug-eluting stents, and lower presence of inflammation and foreign body reaction in multiple preclinical studies. Furthermore, I have long believed that the next generation of stents can benefit from biodegradable polymers. The data I've seen on the SynBiosys biodegradable polymer suggest it is very biocompatible with low inflammatory scores that could also result in improved endothelialization.”