Data Published in JACC: Cardiovascular Interventions Show that OrbusNeich's COMBO Dual Therapy Stent™ Reaches Primary Study Endpoint and Is Effective in Controlling Neointimal Proliferation

HONG KONG, April 16, 2013 /PRNewswire/ -- OrbusNeich today announced that data from the REMEDEE (Randomized Evaluation of an abluMinal sirolimus coatED bio-Engineered stEnt) study published online in JACC: Cardiovascular Interventions demonstrated that the COMBO Dual Therapy Stent met the study's primary endpoint and was found to be effective in controlling neointimal proliferation. Specifically, the COMBO Stent was shown to be non-inferior to a drug eluting stent (DES) with respect to angiographic in-stent late lumen loss at nine months. Further, the COMBO Stent was shown to be safe, with an overall low rate of clinical events, a low rate of binary restenosis and no stent thrombosis (ST) observed up to 12 months.

The COMBO Dual Therapy Stent combines an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days with a proven pro-healing antibody surface coating.

At nine-month angiographic follow-up, the in-stent late lumen loss for the COMBO Stent was 0.39 +/- 0.45 mm compared to 0.44 +/- 0.56 mm for the control DES – the TAXUS® Liberte® paclitaxel-eluting stent. This is well below the threshold of 0.50 mm shown in the literature to be effective in preventing repeat revascularization.

At 12 months, the major adverse cardiac event (MACE) rate, defined as a composite of death, myocardial infarction (MI), emergent coronary artery bypass grafting (CABG), or target lesion revascularization (TLR) by repeat percutaneous transluminal coronary angioplasty (PTCA) or CABG, was 8.9 percent for the COMBO Stent group and 10.2 percent for the DES group. The clinically driven TLR rate and the clinically driven target vessel revascularization (TVR) were 4.9 percent and 6.5 percent, respectively, for the COMBO Stent group and 8.5 percent and 10.2 percent, respectively, for the DES group. No difference in mortality or occurrence of MI was observed, and no ST was reported in either group.

"Late and very late ST and a lack of durability of clinical effectiveness in the longer term remain issues with today's monotherapy DES," said Prof. Dr. Michael Haude of the Medical Clinic I, Lukaskrankenhaus, Neuss, Germany, and first author of the publication. "With the COMBO Dual Therapy Stent, we have an innovative stent technology that may accelerate early healing and neointimal stent strut coverage to allow for a shorter duration of dual antiplatelet therapy (DAPT) without compromising efficacy in respect to in-stent late lumen loss, restenosis and the need for reintervention. Additionally, intravascular ultrasound (IVUS)-virtual histology (VH) results revealed a bare metal stent (BMS)-like composition and morphology of the neointimal tissue for the COMBO Stent group versus DES, suggesting that the COMBO Stent may have the long-term safety profile of a BMS."

At nine months, IVUS revealed a numerically lower neointimal hyperplasia volume of 21.5 +/- 21.7 mm³ versus 25.9 +/- 18.7 mm³ for the COMBO Stent compared to DES. The in-stent volume obstruction was 15.24 +/- 14.22 percent for the COMBO Stent versus 14.59 +/- 8.38 for DES. An IVUS-VH comparison of the COMBO Stent with DES found a significantly less necrotic core area at maximum site on neointimal hyperplasia of 0.25 mm² for the COMBO Stent versus 0.46 mm² for DES and a less confluent necrotic core of 10 percent for the COMBO Stent versus 80 percent for DES.

In the study, 183 patients with de novo native coronary artery stenoses were randomized 2:1 to COMBO Stent or DES implantation. The study's primary endpoint was in-stent late lumen loss at nine months. Secondary endpoints included device, lesion and procedural success, all-cause and cardiac mortality, MI, MACE and ST, as well as clinically (ischemia) driven TLR and clinically (ischemia) driven TVR at 30 days, nine months and one through five years. In-stent and in-segment angiographic binary restenosis, in-stent and in-segment minimum lumen diameter and neointimal hyperplasia volume and percent in-stent volume obstruction were measured by IVUS at nine months. Baseline IVUS was performed in a subgroup of 66 patients (45 patients from the COMBO Stent group and 21 patients from the DES group), and IVUS follow-up at nine months consisted of 35 from the COMBO Stent group and 17 from the DES group.

The average pre-procedure reference vessel diameter (RVD) was 2.77 mm for the COMBO Stent group and 2.85 mm for the DES group, and the average lesion length was 13.69 mm for the COMBO Stent and 14.64 mm for DES. Of the lesions treated, 66.2 percent were type B2/C lesions in the COMBO Stent group and 61.0 percent were type B2/C in the DES group. For patients treated with the COMBO Stent, 33.1 percent had diabetes mellitus, compared to 37.3 percent for DES.

"The promising results from the first-in-man REMEDEE study not only confirm the COMBO Stent's safety and efficacy at one year, but they also differentiate the COMBO Stent from current monotherapy DES," said Stephen M. Rowland, Ph.D., vice president of research & development at OrbusNeich. "The COMBO Dual Therapy Stent reflects OrbusNeich's commitment to addressing the limitations of today's stent technology through ongoing innovation."

About the COMBO Dual Therapy Stent

The COMBO Dual Therapy Stent is the first dual therapy stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

OrbusNeich's patented endothelial progenitor cell (EPC) capture technology promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous™ Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. Development stage products include the COMBO Dual Therapy Stent, the world's first dual therapy stent. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.

Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich, and learn more about the company and its innovative technology on OrbusNeich's YouTube Channel: http://www.youtube.com/user/OrbusNeichMedia.

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