OrbusNeich Medical K.K. of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent. The COMBO Plus Coronary Stent is the first drug-eluting stent [DES] to combine the proprietary endothelial progenitor cell [EPC] capture technology with an abluminal sirolimus drug elution delivered from a biodegradable matrix polymer that achieves full and complete dissipation by 90 days. OrbusNeich's patented immobilized antibody promotes the capture of EPCs circulating in the blood to the device surface. EPCs have been shown to promote the formation of a functional endothelial layer that provides protection against thrombosis and modulates restenosis.
The pivotal randomized, multi-center HARMONEE (Harmonized Assessment by Randomized, Multi-center Study of OrbusNEich's COMBO StEnt) [NCT02073565] was conducted as a global clinical "proof-of-concept" project under the joint Japan PMDA-US FDA Harmonization by Doing initiative and the study provided the pivotal clinical data used to support the Shonin approval. A total of 572 patients were enrolled at 50 sites in Japan and the U.S. to support the company's application for Shonin approval in Japan and to meet the Pilot trial requirements in the U.S. Patients presenting with ischemic coronary disease and non-ST segment myocardial infarction (NSTEMI) were randomized one-to-one to treatment with a COMBO Plus Stent or an everolimus-eluting stent (EES) comparator. The study's primary endpoint was met in a comparison of clinically driven target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) or ischemia- driven target vessel revascularization (TVR) by percutaneous or surgical methods. The COMBO Plus stent was found to be non-inferior in 1-year TVF compared to the EES comparator. Additionally, the COMBO Plus stent was found to have superior healthy stent strut coverage compared to the EES control as determined by an independent OCT Core Laboratory analysis of serial optical coherence tomography [OCT] imaging at 6- and 12-months. (European Heart Journal 2018; 39:2460-2468)
Dr Mitchell Krucoff, Duke University Medical Center, Durham, N.C, USA, and the Global Co-Principal Investigator for the HARMONEE trial, stated "The OrbusNeich Combo DES with endoluminal biologic endothelial progenitor cell capture technology has just become the first coronary device approved for clinical use in Japan based on the HARMONEE study which enrolled both Japanese and US human subjects in a single prospective randomized trial protocol. Not only is this a huge success for the COMBO DES, but it is also a first-in-kind proof of concept for the Japan-USA Harmonization By Doing program (HBD)."
The COMBO Plus stent is designed to address the risk of stent thrombosis associated with delayed healing found with conventional DES. The unique dual therapy stent design combines anti-restenotic effectiveness by abluminal sirolimus elution from a bioresorbable polymer matrix with pro-healing antibody surface coating for enhanced EPC capture from the circulating blood, resulting in more complete healing and endothelial functionality. The COMBO Plus stent clinical program now has over 9,500+ subjects included in clinical trials with the COMBO stent. The CE-marked COMBO Plus Dual Therapy stent has claims based upon clinical results from this extensive clinical program, including indications to allow for flexibility in dual-antiplatelet therapy [DAPT] if needed, with a recommended minimum one-month DAPT in stable patients and three-months DAPT in acute coronary syndrome [ACS] patients.
"The market approval of the COMBO Plus Coronary Stent in Japan is a tremendous achievement for the entire OrbusNeich organization" said David Chien, OrbusNeich Medical President and CEO. "A well-coordinated global effort was required to obtain the Japan market approval of a unique product such as the COMBO Plus Coronary Stent. We expect this approval to allow OrbusNeich build on our strong market position in the Japan percutaneous interventional market."
About the COMBO Plus Coronary Stent
The COMBO Plus Coronary Stent is the first stent to combine a proprietary endothelial progenitor cell [EPC] capture technology on the luminal stent surface with an abluminal sirolimus drug elution delivered from a biodegradable matrix polymer that is completely dissipated within 90 days. OrbusNeich's patented EPC capture technology consists of an immobilized antibody surface coating that captures EPCs circulating in the blood to the device surface.
About OrbusNeich – Pioneers in life-changing technologies
OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products are the COMBO PLUS Coronary Stent, together with stents and balloons marketed under the names of AZULE(R), SCOREFLEX(R), SCOREFLEX(R) NC, SAPPHIRE(R) II, SAPPHIRE(R) II PRO and SAPPHIRE(R) II NC, and the TELEPORT(R) microcatheter, as well as products to treat peripheral artery disease: the JADE(R) and SCOREFLEX(R) PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com