Medtronic NC Euphora Coronary Balloon Receives FDA Clearance

September 11, 2014—Medtronic, Inc. announced US Food and Drug Administration 510(k) clearance of its NC Euphora noncompliant balloon dilatation catheter. The device has been commercially launched and will be featured by the company at the TCT 2014: Transcatheter Cardiovascular Therapeutics meeting on September 13–17, in Washington, DC.
 
Medtronic will also be unveiling a new website, “Cath Lab Connect” (www.cathlabconnect.com), which is being developed for catheterization lab nurses and technicians to increase education and peer-to-peer engagement. The website will feature educational resources, programs, and webinars, as well as provide opportunities for networking and best-practice sharing to improve patient care and operational efficiencies in catheterization labs throughout the world.
 
According to Medtronic, the NC Euphora device includes the company’s PowerTrac technology, which provides superior deliverability through challenging lesions and requires less force to track through tortuous anatomy. An optimized tapered tip design and low lesion entry profile improve flexibility and allow for reliable stent recross when traversing long, challenging lesions so that the balloon does not catch on a strut when passing through a deployed stent.
 
The device’s strong and flexible balloon material provides high pressure capability, enabling the NC Euphora to expand consistently within the stent area at a rated burst pressure of up to 20 atm without bursting. Significantly low radial growth reduces unwanted vessel expansion, and low longitudinal growth beyond the stent length will minimize damage to the surrounding healthy artery.
 
Additionally, the NC Euphora is packaged in a reduced box size with a broad size range that is labeled clearly and intuitively.
 
After drug-eluting stent implantation to treat a blocked artery, a noncompliant balloon is inflated to a high pressure to ensure that the stent is fully apposed in order to facilitate transfer of the drug to the artery wall. Postdilatation with noncompliant balloons has been recommended to provide optimal stent expansion after drug-eluting stent implantation and to overcome potential complications from stent underexpansion, including restenosis and stent thrombosis, noted Medtronic.
 
In Medtronic’s announcement, David Kandzari, MD, Director of Interventional Cardiology and Chief Scientific Officer at the Piedmont Heart Institute in Atlanta, Georgia, commented, “When developing NC Euphora, insights from the entire cath lab team were gathered and addressed to ensure it meets the current needs of cath lab professionals in device design and performance. The advanced design characteristics of NC Euphora provide physicians with a reliably deliverable noncompliant balloon catheter to ensure success in challenging coronary angioplasty procedures.”
 
Chad Dupree, RTR, a catheterization lab staff member at the Piedmont Heart Institute, added, “The advanced features of NC Euphora demonstrate that not all balloon catheters are the same. The cath lab team recognizes that balloon catheters are a key component of the procedure, and availability of a device that optimizes stent deployment presents a key opportunity that we have to achieve procedural success.”