Cordis, a Cardinal Health company and a world leader in cardiology and endovascular devices, will begin marketing the technologically advanced Railway Sheathless Access System in India this year.
Cordis’ Railway System is indicated for use in radial artery procedures requiring the percutaneous introduction of intravascular devices.
A percutaneous procedure is a method that allows doctors to insert a medical device into a patient's blood vessel by using a needle, a guidewire, an introducer sheath and a catheter. The catheter is used to deliver medication or implant a stent into the blood vessel.
The innovative Railway System is designed to enable direct access to the radial artery in the wrist with a guiding catheter without the use of an introducer sheath. This reduces the size of the arterial puncture site by up to 2F compared to a conventional sheath system.
The Railway System received the European CE Mark approval in March 2017 and U.S. Food & Drug Administration clearance in April 2018. The Railway System will be available in India later this year.
Cardiovascular disease (CVD) is now the leading cause of death in India with one in four people dying because of CVD. Ischemic heart disease and stroke are responsible for more than 80 per cent of CVD deaths in India. The use of percutaneous coronary intervention to treat CVD in India has sharply increased with transradial access for cardiac catheterization and intervention growing steadily over the last 10 years.
Transradial cardiac catheterization is a procedure used to treat and diagnose certain heart conditions. This endovascular procedure can access the body’s arterial system from the radial artery in the wrist.
The Railway System will help to overcome some of the current limitations of transradial access and enable physicians to treat more complex lesions via radial access and expand the availability of this minimally invasive, patient friendly trans-radial approach for more patients.
“In our experience, the Cordis Railway sheathless access system minimizes the radial artery trauma and disruption, by reducing artery puncture size up to 2F (33 per cent) while allowing larger bore guide catheter use during trans-radial coronary procedures. In our study, the Railway system reduced the incidence of spasms, radial trauma and improved the transradial access success rate for complex coronary procedures. This resulted in reduced vascular complications, leading to early ambulation and discharge from the hospital. " said Dr Kintur Sanghvi, Associate Medical Director of Interventional Cardiology and Endovascular Medicine at Deborah Heart & Lung Center in Browns Mills, New Jersey, the inventor of the Railway System.
“Cardinal Health is a leader in the cardiovascular and endovascular spaces. Our goal is to bring the best medical devices to India. We hope that by introducing the Railway system in India we will be able to help improve patient outcomes and provide Indian doctors with better treatment options for people suffering from heart disease.” said Clara Tan, Cardinal Health’s Managing Director, Emerging Asia.