AsiaNet 85738

HONG KONG, Sept. 23, 2020 /PRNewswire=KYODO JBN/ --

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