Irish medical technology firm Medtronic has received 510(k) approval from the US Food and Drug Administration (FDA) for its Euphora semicompliant balloon dilatation catheter.
According to the company, Euphora is a pre-dilatation therapy used during a stent implantation to reopen a narrowed coronary artery caused by plaque buildup.
Medtronic coronary and structural heart division coronary and renal denervation business general manager and vice-president Jason Weidman said: "With the addition of the Euphora semicompliant balloon we are able to provide physicians with one of the most robust and best-in-class interventional product portfolios available on the market.
"This launch delivers on our strategy of introducing a breadth of premium products, and exemplifies our continued commitment to deliver innovative and differentiated technologies that address the needs of cath lab professionals around the world."
The Euphora catheter features new delivery system with PowerTrac technology, which helps in better deliverability through challenging lesions.
It also features a tapered proprietary inner shaft design and an optimized mini-wrap that decreases the wall thickness of the balloon, allowing to create an extremely low crossing profile.
In addition, the catheter includes an improved insertion and retraction force to enhance navigation to lesion sites when using the kissing balloon technique.
Medtronic has announced the availability of the Euphora balloon in the US market.
The Euphora semicompliant balloon obtained CE mark approval in December 2014, expanding its interventional portfolio of medical devices across coronary, renal denervation and TAVR.
The company is also planning to launch Cath Lab Connect, an informational portal and community website for cath lab nurses and technicians.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.