Oct 8 A federal advisory panel recommended that Medtronic Inc be allowed to sell a line of implantable heart rhythm devices to a larger pool of patients, based on research showing the products lowered the risk of death and hospitalization.
The panel of expert advisers to the U.S. Food and Drug Administration voted 4-3 on Tuesday to recommend approval for the products in patients who suffer from an abnormal heart rhythm called atrioventricular block.
About one million Americans have atrioventricular block, which reduces heart function by blocking the electrical signals between its top and bottom chambers.
The Medtronic products, called cardiac resynchronization therapy defibrillators and pacemakers, deliver electrical impulses to both lower chambers of the heart to restore its normal rhythm.
Patients with atrioventricular block currently can receive a traditional pacemaker, which delivers impulses to the right ventricle only.
Medtronic requested an expanded indication for its CRT-D (defibrillator) and CRT-P (pacemaker) devices based on results from a clinical study that showed a reduced risk of death or hospitalization for patients with atrioventricular block who get the products. The devices are implanted in the chest.
The FDA typically follows the advice of its advisory panels, though it is not required to do so.