Ohio Heart Physicians at The Christ Hospital Implant First Side Branch Stent in the U.S.
Jan 31st 2011
Cincinnati, Ohio – Physicians at The Christ Hospital in Cincinnati, Ohio, have implanted the first Tryton Side Branch Stent in the U.S., as part of a pivotal clinical trial for the treatment of coronary artery disease. Thomas M. Broderick, M.D., a cardiologist with The Christ Hospital Heart and Vascular Center, treated the first U.S. patient in the study with the stent. The patient, a 53-year-old man from Lebanon, Ohio, is doing well and is available for interview. The Tryton study is being conducted by The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital (The Lindner Research Center).
“Stenting at a side branch artery connection has always been a challenge with an increased risk of obstructing the connection and a long-term increased risk for re-narrowing. The special characteristics of this stent may prove to be the answer to this difficult situation. Early trials in Europe have been very encouraging,” said Dr. Broderick.
Coronary artery disease often results in the build-up of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these blockages are technically difficult. If the side branch is left unstented, it is often vulnerable to higher rates of restenosis, or the re-narrowing of the stented artery, following implantation. The goal of using this stent is to offer patients a treatment option which may allow them relief from symptoms, potential heart attacks and further heart damage.
Tryton’s cobalt chromium stent is deployed through a catheter in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.
The randomized, controlled study will compare the use of the Tryton stent placed in the side branch artery in conjunction with a standard drug eluting stent in the main vessel vs. the use of angioplasty (opening of the artery without stent placement) in the side branch with a standard drug eluting stent in the main vessel for the treatment of complex bifurcation disease.
The study will enroll 704 patients at up to 75 centers in North America and Europe. The primary endpoint of the study is to determine the device’s safety and effectiveness at nine months. A secondary endpoint is to review the diameter of the Tryton stented artery at nine months, to determine if it has remained open and flexible or if any rigidity or narrowing (restenosis) has taken place in the side branch vessel.
“Bifurcation lesions are a serious challenge facing U.S. physicians and many patients with coronary artery disease,” said Dean Kereiakes, M.D., medical director of The Christ Hospital Heart and Vascular Center and The Lindner Research Center, and site principal investigator. “The Tryton System offers an innovative solution for these difficult cases. We are extremely pleased to have enrolled the first patient in the U.S. in this important study, and we are encouraged by the overall performance of the device.”
For more information about this study, please contact The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital at 513-585-1777.
About The Carl and Edyth Lindner Center for Research and Education: For the past 25 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted more than 1,200 clinical trials including multiple first-in-man and first-in-the-U.S procedures, which have contributed to best practice standards for the care of patients. For information on current trials, please call 513-585-1777.
About The Christ Hospital: The Christ Hospital offers a wide range of medical, surgical and testing services at its main campus just north of Downtown Cincinnati and at numerous outpatient and physician practice locations throughout Greater Cincinnati. Its mission is to provide the finest patient experience and improve the health of our community. For the past 11 years, The Christ Hospital has been recognized by U.S. News & World Report as one of the nation’s top hospitals, and has been named Cincinnati’s Most Preferred Hospital for 15 consecutive years by National Research Corporation (NRC). The Christ Hospital has been granted Magnet® recognition from the American Nurses Credentialing Center for excellence in
nursing care. For more information about the award-winning services of The Christ Hospital, visit www.TheChristHospital.com.
About Tryton Medical, Inc.: Tryton Medical, Inc., located in Durham, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth-Hitchcock Medical Center) and Dan Cole to develop stents for the definitive treatment of bifurcation lesions. The Tryton Side Branch Stent System, approved for sale in Europe, is designed to offer a dedicated strategy for treating these challenging cases. Privately held, Tryton is backed by Arnerich Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest Ventures. For more information please visit www.trytonmedical.com.