September 23, 2020
OrbusNeich’s Combo Coronary Stent Approved in China
September 23, 2020—OrbusNeich Medical Co. Ltd. announced that China’s National Medical Products Administration (NMPA) has granted market approval for the company’s Combo bioengineered sirolimus-eluting stent in China. OrbusNeich, which is headquartered in Hong Kong, has operations in Shenzhen, China; Fort Lauderdale, Florida; Hoevelaken, The Netherlands; and Tokyo, Japan.
According to the company, the dual-therapy stent both accelerates endothelial coverage and controls neointimal proliferation through the combination of the prohealing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer to achieve complete dissipation by 90 days. The device features OrbusNeich's endothelial progenitor cell-capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents.
OrbusNeich advised that the NMPA approval in China was supported by clinical data from the ongoing randomized, multicenter RECOVERY trial comparing the Combo stent with the polymer-free sirolimus-eluting stent (PF-SES; Nano; Lepu Medical Technology) in the treatment of patients with de novo native coronary artery lesions. In the RECOVERY trial, a total of 432 patients were enrolled at 16 centers in China and randomized one-to-one to the treatment with the Combo stent or the treatment with PF-SES.
The Combo stent was found to be noninferior in the study’s primary endpoint of 9-month angiographic in-segment late lumen loss (LLL) compared with the PF-SES, with in-segment LLL of 0.29 ± 0.46 mm and 0.31 ± 044 mm respectively (P = .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, reported OrbusNeich.