Tag: OrbusNeich

First patients treated in United States with OrbusNeich Teleport Microcatheter

The first patients in the United States have been treated using the OrbusNeich Teleport Microcatheter (Teleport; Cardiovascular Systems), which recently received US Food and...

First patient in Hong Kong receive treatment with coronary Orbital Atherectomy...

The first patient in Hong Kong has been treated with the Diamondback 360 coronary Orbital Atherectomy System (Cardiovascular Systems). A press release reports that...

Cardiovascular Systems signs international distribution agreement with OrbusNeich

Cardiovascular Systems, Inc. (CSI) has signed an exclusive international distribution agreement with OrbusNeich to sell its coronary and peripheral orbital atherectomy systems (OAS) outside...

Sapphire II PRO becomes US’s first and only 1mm coronary balloon

Cardiovascular Systems has announced that the US FDA has granted 510(k) clearance for the OrbusNeich 1mm Sapphire II PRO coronary balloon. The approval means...

TCT 2017: Combo dual-therapy stent is non-inferior to Xience at one...

New results from the HARMONEE Japan/US registration trial, which were presented yesterday at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October – 2...

OrbusNeich announces FDA clearance and launch of coronary dilatation catheters

OrbusNeich has announced the launch of its Sapphire percutaneous coronary angiography balloon dilatation catheters (Sapphire II PRO and Sapphire NC Plus) following their recent...

OrbusNeich releases next-generation coronary scoring balloon

OrbusNeich has launched the Scoreflex NC, a non-compliant scoring balloon targeting more resistant lesions. The product is a focused force dual-wire balloon system built...

Two major studies of Combo dual therapy stent complete enrolment

OrbusNeich has announced that two major clinical studies have now completed enrolment. The studies—HARMONEE (Harmonized assessment by randomised, multicentre study of OrbusNeich’s Combo stent)...