Cordis Introduces PCI Devices at EuroPCR
May 15, 2017— Cordis, Cardinal Health’s interventional vascular business, announced the commercial launch of three new products that further enhance its interventional cardiology product portfolio in Europe, the Middle East, and Africa (EMEA). The products include the Railway sheathless access system, as well as two percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, Ikazuchi Zero and Raiden 3.
These devices add to Cordis’ product portfolio that supports the treatment of patients undergoing percutaneous coronary intervention (PCI) from access and diagnosis to intervention and closure. Cordis and Cardinal Health are introducing the devices at the EuroPCR 2017 conference being held May 16–19 in Paris, France.
In April, Cordis announced European CE Mark approval for the Railway device, which is indicated for use in radial arterial procedures requiring the percutaneous introduction of intravascular devices.
According to the company, the Railway system enables direct access to the radial artery with either Adroit or Vista Brite Tip guiding catheters (Cordis) and eliminates the need for an introducer sheath, which represents a 2-F size reduction compared with a conventional sheath system. The Railway sheathless access system is compatible with the Cordis 5-, 6-, and 7-F guiding catheters, including dedicated radial shapes.
The Ikazuchi Zero and Raiden 3 PTCA balloons are being launched under the Kaneka brand name across EMEA. In October 2016, Cardinal Health announced a distribution agreement with Japanese manufacturer Kaneka that enables Cordis to distribute Kaneka’s PTCA balloon catheters, which recently received CE Mark approval for marketing in EMEA.
Cordis stated that these Japanese PTCA balloons are engineered for smaller and narrower lesions, suiting them for both everyday and complex cases. Ikazuchi Zero includes a low profile 1-mm-diameter predilatation balloon, and Raiden 3 offers rated burst pressures of up to 22 atm. These devices are not available for sale in the United States and certain other countries.