OrbusNeich Medical Co. Ltd. has announced that the National Medical Products 
Administration (NMPA) has granted market approval for the COMBO BIO-ENGINEERED 
SIROLIMUS ELUTING STENT in China. It is the first dual therapy stent to both 
accelerate endothelial coverage and control neointimal 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.

"The market approval of the COMBO Stent in the Republic of China is a 
strategically important success for the OrbusNeich organization as we further 
expand into significant territories," said David Chien, OrbusNeich's Chairman, 
President and CEO. "We expect the approval of a unique product such as the 
COMBO Stent to allow OrbusNeich to strengthen our presence in China alongside 
our existing PTCA and PTA portfolio."

The ongoing randomized, multi-center RECOVERY trial [NCT02542007] comparing the 
COMBO Stent with the polymer-free sirolimus-eluting Nano stent (PF-SES) (Lepu 
Medical Technology, Beijing, China) in the treatment of patients with de novo 
native coronary artery lesions provided clinical data supporting the approval. 
A total of 432 patients were enrolled at 16 centers in China and randomized 
one-to-one to the treatment with COMBO Stent or the treatment with PF-SES. In 
this positive trial, the COMBO Stent was found to be non-inferior in the study 
primary endpoint of 9-month angiographic in-segment late lumen loss compared to 
the PF-SES, with in-segment LLL of 0.29 plus-minus 0.46 mm and 0.31 plus-minus 
044 mm respectively (p = 0.57). At 1-year, clinical outcomes were similar 
between the groups for target lesion failure (TLF), a composite of cardiac 
death, target-vessel myocardial infarction, or ischemia-driven target lesion 
revascularization, and all TLF components. There was no stent thrombosis in 
either group.

"Since its launch, the COMBO Stent has played an important role in helping 
patients with coronary artery disease," said Senior Vice President and Chief 
Commercial Officer, Alain Khair. "The COMBO Stent, with its unique pro-healing 
properties, is another example of OrbusNeich's commitment to providing 
innovative best-in-class devices to our physicians and their patients."

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 Stent, 
together with stents and balloons marketed under the names of COMBO Plus, 
AZULE(R), SCOREFLEX(R), SCOREFLEX(R) NC, SAPPHIRE(R) II PRO, SAPPHIRE(R) 3 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.

Source: OrbusNeich Medical Co ltd