CardiovascularMedtronic's Corevalve Shows Subclavian Access Success In Patients Contraindicated For Femoral Approach
Medtronic, Inc. (NYSE: MDT) announced new data
presented today on the safety and effectiveness of Medtronic"s CoreValve system via a
novel, subclavian approach. The data reported procedural success of 100 percent; 24-
hour survival of 100 percent; and 30-day survival of 89 percent. The available 30-day
analysis also demonstrated clinical improvement in heart failure symptoms with 76
percent of the patients gaining at least a oneņstage NYHA class and oneņthird
improving by at least two stages.
Medtronic"s marketņleading CoreValve system was designed to allow the implant of a
replacement heart valve in patients with aortic stenosis who are at high or prohibitive
surgical risk. The system enables a catheterņbased implant via a peripheral blood vessel,
traditionally the femoral artery. A significant subset of patients, however, have
compromised peripheral arteries, which prevents the use of the femoral approach.
Uniquely, the delivery system of the CoreValve device is small enough to allow an
alternative approach via the subclavian artery beneath the collar bone.
"The combination of unique valve design and controlled deliverability have contributed
to the tremendous success of the Medtronic CoreValve system using the femoral
approach," said John Liddicoat M.D., vice president and general manager of the
CardioVascular Structural Heart division at Medtronic. "These new data suggest that a
subclavian artery approach could address yet another underņserved patient population.
We are committed to gather the necessary clinical experience and evidence to support
the routine use of a subclavian approach in those for whom a femoral approach is not
possible."
The data presented today at the PCR interventional cardiology meeting in Barcelona
reported on data from 74 patients for whom subclavian access was used within the
CoreValve Extended Evaluation Registry, an observational study which closed in
January 2009. The average age of the patients was 81.4. Moreover, the average Logistic
EuroSCORE (a measure which predicts risk of procedural mortality based upon patient
status) was notably high at 28.4%.
Medtronic