|
FDA OKs Medtronic's Euphora Non-Compliant Coronary Balloon Catheter
|
 |
September 11, 2014 -- Coming just four months after its CE Mark European approval, the NC Euphora balloon has received the okay from the FDA for marketing in the United States.
Non-compliant (NC) balloons are specifically designed to be used in post-stent dilatation, to ensure that the stent itself is fully expanded against the arterial wall. An under-expanded stent is associated with higher restenosis rates, as well as stent thrombosis.
Dr. Antonio Colombo |
This phenomenon was first described by Dr. Antonio Colombo in the early days of stenting. He used intravascular ultrasound to assess stent expansion and found that most stents were being deployed under-expanded. Pioneering the use of a high-pressure balloon, Dr. Colombo routinely expanded the stent after its initial placement.
The result: success rates and restenosis in stent cases were significantly reduced. (You can read in more detail about this issue in Angioplasty.Org's interview with Dr. Colombo.)
In the ensuing years, post-stent expansion has become an important technique utilized in percutaneous coronary interventions (PCI). Today a number of NC balloons are currently on the market. Medtronic has offered the NC Euphora which, as described in the press release below, has several differentiating characteristics, allowing safe and easy passage of the balloon through the stent: a key feature since any device or wire passed through an implanted stent has the risk of catching on a strut and causing a deformation of the stent structure.
This morning's press release from Medtronic, Inc. follows:
Medtronic NC Euphora™ Coronary Balloon Receives FDA Clearance
• Superior Deliverability [1] and Uncompromising Performance Distinguishes New Angioplasty Balloon
• New "Cath Lab Connect" Website Will Provide Catheter Lab Professionals with
Educational Resources and Best Practice Sharing Platform
September 11, 2014 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the NC Euphora(TM) Noncompliant Balloon Dilatation Catheter. The new device will be featured for the first time in the United States at the Medtronic booth at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in Wash., DC from Sept. 13-17.
Following drug-eluting stent implantation to reopen a narrowed artery, a noncompliant balloon is inflated with high pressure to ensure that the stent is fully apposed in order to facilitate transfer of the drug to the artery wall. Stent under-expansion has been defined as a major risk factor for both artery re-narrowing, or restenosis, and the potential formation of blood clots, known as stent thrombosis. Postdilatation with noncompliant balloons has been recommended to overcome these complications and provide optimal stent expansion after stent placement.
Dr. David Kandzari |
"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," said David Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, at the Piedmont Heart Institute in Atlanta, GA. "The advanced design characteristics of NC Euphora provide physicians with a reliably deliverable noncompliant balloon catheter to ensure success in challenging coronary angioplasty procedures."
The NC Euphora Balloon Catheter was designed for uncompromising performance to provide clinicians with several valuable features, including:
- Superior Deliverability: PowerTrac™ technology provides superior deliverability through challenging lesions and requires less force to track through tortuous anatomy. [1]
- Excellent Re-cross: An optimized tapered tip design and low lesion entry profile improves flexibility and allows for reliable stent re-cross when traversing long, challenging lesions so that the balloon does not catch on a strut when passing through a deployed stent. [2]
- Durability: Strong and flexible proprietary balloon material provides high pressure capability [1], which enables NC Euphora to expand consistently within the stent area at a Rated Burst Pressure (the maximum pressure that the balloon can be repeatedly inflated in a safe manner) of up to 20 atmospheres without bursting.
- Low Growth Profile: Significantly low radial growth to reduce unwanted vessel expansion and low longitudinal growth beyond the stent length to minimize damage to the surrounding healthy artery.
- Enhanced Packaging: Environmentally friendly packaging and a reduced box size that has a smaller footprint on congested shelves and a broad size range labeled clearly and intuitively.
"The advanced features of NC Euphora demonstrate that not all balloon catheters are the same," said Chad Dupree, RT(R), cath lab staff member at the Piedmont Heart Institute. "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."
NC Euphora expands Medtronic's interventional portfolio of medical devices across Coronary, Renal Denervation and TAVI, and is the latest in a series of 12 new product introductions planned over the next 2 years.
"Cath Lab Connect" Website Unveiled
In an effort to increase education and peer-to-peer engagement among catheter lab professionals, Medtronic also previewed a new website, "Cath Lab Connect," dedicated to catheter lab nurses and technicians. The website will feature educational resources, programs and webinars, as well as provide opportunities for networking and best practice sharing to ultimately help improve patient care and operational efficiencies in catheter labs around the globe. To learn more, visit: www.cathlabconnect.com.
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, Inc. (www.medtronic.com), headquartered in Minneapolis, 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. NC Trek and Quantum Apex balloons on file at Medtronic, Inc. Bench test data may not be indicative of clinical performance.
[2] Medtronic NC Euphora, NC Trek and Quantum Apex 3.00mm x 20mm balloons tested. Testing completed using Medtronic stents. Bench test data may not be indicative of clinical performance.
Reported by Burt Cohen, September 11, 2014
|
