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St. Jude Medical Announces Initial Results of International Heart Valve Clinical Trial
ST. PAUL, Minn.--(BUSINESS WIRE)--Dec. 20, 2001--
GELIA Study Examines Optimal Anticoagulation Medication Levels
for Mechanical Heart Valve Patients
St. Jude Medical, Inc. (NYSE:STJ) today announced the initial results of the German Experience in Low Intensity Anticoagulation Trial (GELIA), the largest prospective randomized cardiac valve trial ever conducted. The study's preliminary results appear in the European Heart Journal's December supplement.
The GELIA study, directed by Professor Dieter Horstkotte, Director of the Heart Center Nordrhein Westfalen, enrolled 2848 patients to determine optimal ranges of anticoagulant (blood-thinning) medication for patients with St. Jude Medical(R) mechanical heart valves.
While mechanical heart valve patients benefit from the lifetime durability of their valves, they must take blood-thinning medication to keep their anticoagulation levels within a targeted therapeutic range.
The multi-center GELIA trial followed St. Jude Medical(R) mechanical heart valve patients from Germany and Switzerland for seven years, beginning in 1993. Patients were randomly assigned to one of three anticoagulation levels and were required to report their blood testing results and complications every three months. The information was verified by physician records.
The study found that the rate of thromboembolic complications with the St. Jude Medical valve was very low (1.36 percent) per patient-year, regardless of the patient's anticoagulation therapy level. The study also showed that for patients with only one valve replacement, the lowest of the trial's three anticoagulation therapy levels resulted in the lowest complication rates.
Study results from a subset of the patient population found that patients who monitor and participate in the management of their blood-thinning medication are more effective in maintaining therapeutic levels. Under the supervision of their doctors, these patients used a home monitoring device to more frequently check their anticoagulation levels. The study found that patients using self-testing devices had a reduced rate of complications.
The GELIA results reported in the European Heart Journal supplement offer a global perspective of the management of St. Jude Medical(R) mechanical heart valve patients, incorporating both European and North American standards for anticoagulation therapy levels.
"This landmark trial represents one of the largest cardiac valve patient databases ever studied," said Professor Horstkotte. "The rigorous methodology and exhaustive data collection and analysis make GELIA the definitive study on optimal anticoagulation levels for patients with St. Jude Medical(R) mechanical heart valves."
Approximately 500,000 patients in the U.S. and over 1.1 million patients worldwide have St. Jude Medical(R) mechanical heart valves. The GELIA study is designed to help improve the lifelong management of these patients.
"St. Jude Medical's mechanical heart valves are already recognized for their low complication rates," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery Division. "The initial GELIA results underscore the benefits of our valves and attempt to provide more information regarding the best medication levels for patients to maintain. They also clearly point out the potential value of patient self-testing in optimizing medical management. These findings support our One Valve for Life (SM) initiative, an educational program that offers physician guidance for valve selection and long-term patient management."
In the U.S., St. Jude Medical recently announced an exclusive marketing agreement with LifeScan, Inc., a Johnson & Johnson company, to promote LifeScan's Harmony(TM) INR Monitoring System, which is similar to the patient self-testing system used in the GELIA trial. The U.S. Centers for Medicare and Medicaid Services (CMS) has announced its intent to cover anticoagulation home monitoring for Medicare beneficiaries with mechanical heart valves.
St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.
CONTACT:
St. Jude Medical, St. Paul
Investor Relations:
Laura Merriam, 651/766-3029
St. Jude Medical Announces Initial Results of International Heart Valve Clinical Trial
ST. PAUL, Minn.--(BUSINESS WIRE)--Dec. 20, 2001--
GELIA Study Examines Optimal Anticoagulation Medication Levels
for Mechanical Heart Valve Patients
St. Jude Medical, Inc. (NYSE:STJ) today announced the initial results of the German Experience in Low Intensity Anticoagulation Trial (GELIA), the largest prospective randomized cardiac valve trial ever conducted. The study's preliminary results appear in the European Heart Journal's December supplement.
The GELIA study, directed by Professor Dieter Horstkotte, Director of the Heart Center Nordrhein Westfalen, enrolled 2848 patients to determine optimal ranges of anticoagulant (blood-thinning) medication for patients with St. Jude Medical(R) mechanical heart valves.
While mechanical heart valve patients benefit from the lifetime durability of their valves, they must take blood-thinning medication to keep their anticoagulation levels within a targeted therapeutic range.
The multi-center GELIA trial followed St. Jude Medical(R) mechanical heart valve patients from Germany and Switzerland for seven years, beginning in 1993. Patients were randomly assigned to one of three anticoagulation levels and were required to report their blood testing results and complications every three months. The information was verified by physician records.
The study found that the rate of thromboembolic complications with the St. Jude Medical valve was very low (1.36 percent) per patient-year, regardless of the patient's anticoagulation therapy level. The study also showed that for patients with only one valve replacement, the lowest of the trial's three anticoagulation therapy levels resulted in the lowest complication rates.
Study results from a subset of the patient population found that patients who monitor and participate in the management of their blood-thinning medication are more effective in maintaining therapeutic levels. Under the supervision of their doctors, these patients used a home monitoring device to more frequently check their anticoagulation levels. The study found that patients using self-testing devices had a reduced rate of complications.
The GELIA results reported in the European Heart Journal supplement offer a global perspective of the management of St. Jude Medical(R) mechanical heart valve patients, incorporating both European and North American standards for anticoagulation therapy levels.
"This landmark trial represents one of the largest cardiac valve patient databases ever studied," said Professor Horstkotte. "The rigorous methodology and exhaustive data collection and analysis make GELIA the definitive study on optimal anticoagulation levels for patients with St. Jude Medical(R) mechanical heart valves."
Approximately 500,000 patients in the U.S. and over 1.1 million patients worldwide have St. Jude Medical(R) mechanical heart valves. The GELIA study is designed to help improve the lifelong management of these patients.
"St. Jude Medical's mechanical heart valves are already recognized for their low complication rates," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery Division. "The initial GELIA results underscore the benefits of our valves and attempt to provide more information regarding the best medication levels for patients to maintain. They also clearly point out the potential value of patient self-testing in optimizing medical management. These findings support our One Valve for Life (SM) initiative, an educational program that offers physician guidance for valve selection and long-term patient management."
In the U.S., St. Jude Medical recently announced an exclusive marketing agreement with LifeScan, Inc., a Johnson & Johnson company, to promote LifeScan's Harmony(TM) INR Monitoring System, which is similar to the patient self-testing system used in the GELIA trial. The U.S. Centers for Medicare and Medicaid Services (CMS) has announced its intent to cover anticoagulation home monitoring for Medicare beneficiaries with mechanical heart valves.
St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.
CONTACT:
St. Jude Medical, St. Paul
Investor Relations:
Laura Merriam, 651/766-3029
