RADIANT clinical study evaluating safety and performance outcomes of HLT's Meridian® Valve and Pathfinder® II Delivery System for severe aortic stenosis
MINNEAPOLIS, June 6, 2017 /PRNewswire/ -- HLT, Inc. today announced the first U.S. patient implants in an early feasibility clinical study to assess the safety and performance outcomes of the Meridian® Transcatheter Aortic Valve and Pathfinder® II Delivery System in patients with severe aortic stenosis who are at high risk for surgery.
The implant procedures were completed at New York University's Langone Medical Center by Mathew R. Williams, M.D., associate professor, Cardiothoracic Surgery; director, Heart Valve Center; chief, Adult Cardiac Surgery; director, Interventional Cardiology; and U.S. principal investigator of HLT's RADIANT clinical study.
The RADIANT trial is a prospective, non-randomized, single-arm, multicenter study that will enroll up to 20 high-risk patients with severe aortic valve stenosis. The endpoint will evaluate all-cause mortality at 30 days. Patient follow-up will occur at one, six and 12 months and annually to five years.
"The first U.S. implants of our Meridian valve marks a significant milestone in our drive to advance TAVR therapy to meet the needs of patients facing valve replacement who are at high risk for open-heart surgery," said Kevin Bassett, HLT general manager. "We are extremely pleased to work with Dr. Williams and the entire NYU team at their progressive transcatheter valve center."
Transcatheter aortic valve replacement (TAVR) is a less invasive treatment option as compared to surgical valve replacement for these patients. During a TAVR procedure, a compressed replacement valve is advanced, via a catheter (hollow tube) placed in a blood vessel in the upper leg, to the beating heart. "The HLT TAVR design enables us to fully assess valve function prior to releasing the valve in the heart, reposition it to achieve optimal performance prior to final release or retrieve it if necessary," said NYU's Dr. Williams. "As a result, our first procedure with the Meridian valve could be performed quickly and easily. In addition, the level of control that the system provides enabled us to perform the procedure under conscious sedation rather than general anesthesia."
Precise positioning of the new valve is critical to ensure good hemodynamics (blood flow and pressure), avoid leakage around the valve's base and deliver optimal patient outcomes. However, HLT data reveals in up to 25 percent of cases, physicians settle for less-than-ideal positioning because of challenging patient anatomy and disease.
"The Meridian Valve is also uniquely designed with a flexible wire frame to support the leaflets and a shorter height with minimal extension into the left ventricle," said Robert Wilson, M.D., HLT chief scientific and innovation officer and founder.
For more information on the HLT TAVR system, including a video animation, please visit www.hltmedical.com
Editor's note: To download an image of the Meridian Valve, go to http://www.prnewswire.com/news-releases/hlt-announces-first-patient-enrollments-in-a-feasibility-study-of-a-new-transcatheter-aortic-valve-replacement-system-300433920.html
HLT, Inc., is a clinical phase medical device company focused on transcatheter aortic valve replacement therapy that will provide physicians increased procedure confidence, control during the implant procedure and improved patient outcomes. HLT's Meridian® Transcatheter Aortic Valve is designed to conform to the natural structure of the heart, and its Pathfinder® II Delivery System provides physicians control over valve placement in a beating heart, as well as flexibility to reposition or fully retrieve the valve before release.
HLT is headquartered in Maple Grove, Minn. Its team of 90 employees works alongside its sister company ACIST Medical Systems, a pioneer and market leader of advanced contrast delivery and imaging systems for interventional cardiology. The privately held companies are part of the Bracco Group, an international leader in diagnostic imaging based in Milan, Italy. For more about HLT, visit www.hltmedical.com.
About Bracco Group
Bracco has headquarters in Milan, Italy, and was founded in 1927. It is active in the healthcare sector through Bracco Imaging (diagnostic imaging), ACIST Medical Systems and HLT (cardiology) and the Centro Diagnostico Italiano diagnostic clinic. It has around 3,400 employees and annual total consolidated revenues of over $1.38 billion USD (1.3 billion Euro). Bracco operates in more than 100 countries worldwide. To learn more about Bracco Group, visit www.bracco.com.
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Contact: Peggy Malikowski
SOURCE HLT, Inc.