Tag: OrbusNeich

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich Medical Company Ltd (OrbusNeich®), announced FDA PMA approval of OrbusNeich’s Scoreflex® NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (Scoreflex NC). Scoreflex NC is […]

OrbusNeich® Medical and P+F Products & Features® announce new partnership

Introducing a new portfolio of heart valve products aiming to restore health and extend life HONG KONG, Nov. 9, 2020 /PRNewswire/ — OrbusNeich and P+F today announced they have entered into an agreement for the exclusive distribution and manufacturing of a range of innovative minimally invasive heart valve products in the Asia Pacific region, including China, Japan, Taiwan, South Korea, Hong Kong, Singapore, Malaysia, Australia and New Zealand. P+F will […]

OrbusNeich® Announces China Approval for COMBO® Coronary Stent

HONG KONG, Sept. 23, 2020 /PRNewswire/ — 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 […]

OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent

HONG KONG, Sept. 25, 2019 /PRNewswire/ — 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 […]

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon. OrbusNeich’s 1.0mm Sapphire II PRO, the […]

Cardiovascular Systems Expands Product Portfolio to Further Support Peripheral and Coronary Interventions

ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon products. Additionally, the company has signed an original […]