The FDA has approved a new heart device called the Gore Helix Septal Occluder. The new heart device is to help people who have a hole in their heart. “The trick to the device is to have a patch through a small incision in the groin.

A hole in a woman's heart she had since birth. It is common heart defect as many kids are born with this type of condition of having a hole in the heart. Patients born with congenital heart defects are followed throughout their lives by cardiac specialists and later on in life often need heart surgery.

The problem is there is an abnormal hole in the wall between the upper chambers of the heart, causing blood to improperly flow from the left side of the heart to the right, forcing the right side of the heart and lungs to over exert to compensate for the problem.

Using the new device, a doctor creates a patch that fills the hole restoring normal circulation of blood to the heart. This is a new less invasive way compared to traditional open heart surgery.

Some patients can go home the same day with this new way of doing heart surgery.

If left untreated this congenital heart defect can cause the heart to enlarge, or weaken, leaving the patient at risk for serious conditions like pulmonary hypertension, heart failure, or stroke.

Posted by Michael Monheit at 01:40 PM | Permalink

Representative Henry A. Waxman (D-Calif.) and chairman of the Committee on Oversight and Government Reform asked the FDA why defibrillator leads were not tested and scrutinized like defibrillators.

Waxman asked the FDA to provide information about how it determines how much to test leads before marketing and why the agency does not give leads the same scrutiny that it has given in recent years to other heart devices like defibrillators.

A defibrillator is an implanted device that sends out a jolt of electricity to restore a wildly beating heart to normal rhythm. Medtronic, the lead maker, disclosed that a widely used heart lead produced by the company was fracturing and preventing the flow of electricity between the heart and defibrillator.

Some experts believe that the Medtronic lead was prone to fracturing because it was the thinnest lead ever made by the company and might not have been durable enough. Defibrillator leads are known to fracture, but neither the FDA nor device makers have developed effective ways to track such episodes.

The FDA’s Center for Devices and Radiological Health may be reviewing whether to require more strenuous laboratory testing of such products before they go on the market.

Posted by Michael Monheit at 01:42 PM | Permalink