While most think of stents when they think of interventional cardiology, balloons play an important role in percutaneous coronary interventions (PCI). Last fall, Medtronic received FDA approval for its Euphora Non-Compliant Balloon, used to dilate the stent after it has been placed, an important technique to ensure optimal stent expansion.
The Euphora Semicompliant balloon serves a different purpose: to help physicians determine lesion characteristics, stent selection and to facilitate stent access to the lesion – a crucial step for patients with complex blockages. Because of its very low profile, the Euphora is able to navigate easily to the blockage, Because of its semicompliant nature, the Euphora is able to then successfully prepare the area for delivery of a stent because the balloon is able to increase its diameter, within certain limits, through the application of increased pressure.
Because of its extremely low profile, which improves its ability to navigate to and cross lesions, the Euphora Semicompliant Balloon is very useful when treating bifurcation lesions with the Kissing Balloon Technique.
Medtronic Announces CE Mark and European Launch of the Euphora™ Semicompliant Coronary Balloon Catheter
Semicompliant Balloon Brings Greater Deliverability to Combat Challenging Coronary Lesions
February 16, 2015 -- Dublin -- Medtronic plc (NYSE: MDT) today announced the launch of the Euphora™ Semicompliant Balloon Dilatation Catheter in countries that recognize the CE (Conformité Européene) mark. The first patient case with the Euphora Semicompliant Balloon Catheter was recently performed by Richard Edwards, M.D., consultant cardiologist at the Freeman Hospital in Newcastle, United Kingdom. It is not available in the United States.
"After performing the first patient case with Euphora, it is the most deliverable balloon catheter I have used," said Dr. Edwards. "The exceptionally low crossing profile and pushability make it ideal for complex situations and workhorse lesions alike."
Pre-dilatation with a semicompliant balloon helps physicians determine lesion characteristics, stent selection and facilitates stent access to the lesions - a crucial step for patients with complex lesions.
The Euphora Semicompliant Balloon Catheter features several design advancements including:
- Delivery system with PowerTrac™ technology to provide superior deliverability (compared to major competitors)i through tight lesions. The delivery system was first introduced with the Medtronic NC Euphora™ Noncompliant Balloon Dilatation Catheter last year and is also featured with the Medtronic Resolute Onyx™ drug-eluting stent.
- Ultra-slim balloon material, a tapered proprietary inner shaft design and an optimized mini-wrap to reduce the wall thickness of the balloon and contribute to the extremely low crossing profile.[1}
- Significantly improved insertion and retraction force to enhance navigation to lesion sites when using the Kissing Balloon Technique, a method for treating bifurcated lesions.[2]
- Environmentally friendly packaging, a reduced box size that has a smaller footprint on congested shelves and improved product labeling for fast readability to improve efficiency in the cath lab.
- Enhanced crossability may create economic value to the cath labs through the use of a single balloon prepping a lesion, thus reducing the need for the "step up" technique which requires several balloons of different size to first cross the tight lesions and then gradually expand sizing before treating with a stent.
"The Euphora family of balloons is a giant leap forward in balloon technology and builds upon our successful multi-brand strategy, which includes offering premium products at premium prices to help meet different customer needs," said Jason Weidman, vice president and general manager of the Medtronic coronary business. "Along with the previously launched noncompliant version of Euphora, these products exemplify our continued commitment to expand our interventional portfolio with innovative and differentiated technologies that address the needs of cath lab professionals around the world."
The Euphora semicompliant balloon expands Medtronic's interventional portfolio of medical devices across Coronary, Renal Denervation and TAVR, and is the latest in a series of 12 new product introductions planned over the next 2 years.
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is the global leader in medical technology -- alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
[1] Competitive Bench testing vs. Trek, Emerge™, Sprinter™ Legend™ and Ryujin™ Plus balloons. 2.50-mm x 15-mm balloons tested. Bench test data may not be indicative of clinical performance. .
[2] Competitive Bench testing vs. Sprinter™ Legend™ and Emerge. Plus 2.50-mm x 15-mm balloons tested. Bench test data may not be indicative of clinical performance.
