Recently FDA-Approved Medical Devices

Las Vegas—Advances in medical technology can contribute to better outcomes, improve diagnostic acumen, and lead to more standardization in care, according to Paul Solari, MD, director at Genentech, Inc. Dr. Solari spoke at the Fall Managed Care Forum during a session titled Emerging Medical Technologies and the Impact on Managed Care.

Dr. Solari opened with a discussion about Melafind, a device that uses multiple wavelengths of light and computer algorithms to detect melanomas. An estimated 70,000 invasive melanomas are anticipated to be diagnosed this year, and there are 28 cases of melanoma per 100,000 population. The US Food and Drug Administration (FDA) approved Melafind in August. Dr. Solari cited a study comparing Melafind with a panel of 10 blinded dermatologists looking to find melanomas. In 100 cases, Melafind only missed melanoma once, whereas the median accuracy for the dermatologists was 81%. The most successful dermatologist missed 9 of 100 melanomas, while the least successful missed 29 of 100. Dr. Solari then discussed the Melody transcatheter pulmonary valve, the first FDA-approved transcatheter heart valve. The device is intended to treat pulmonary outlet obstruction, a rare birth defect that typically is treated by surgically implanting a cow valve that needs to be replaced every 2 to 3 years.

Dr. Solari said recovery from the cow valve surgery is strenuous, and patients are in the hospital for a long time following the operation. However, he mentioned that studies have shown the Melody valve can improve right ventricular outflow tract (RVOT) conduit function, restore pulmonary valve competence, relieve RVOT obstruction, lengthen conduit lifespan, and delay the patient’s next surgical intervention. In addition, the Helios II Ablation Catheter was recently approved by the FDA to treat supraventricular tachycardia, an ablation of the pathway that can accelerate a person’s heart rate to 200 beats per minute. There are 90,000 new cases of supraventricular tachycardia per year in the United States. The Helios II Ablation Catheter is a flexible catheter that is moved 360 degrees by an external magnetic field.

According to Dr. Solari, a computer memorizes each location and tests the circuits, while the physician works from a shielded console and avoids any radiation. The catheter can return to the specific locations without needing fluoroscopy and reduces radiation time from 27 to 7 minutes. Another device that Dr. Solari mentioned was a prosthetic hearing restoration device from Envoy Medical Corp that the FDA approved in March. In the United States, 15% of people have hearing difficulties, including 50% of people >75 years of age. Dr. Solari said Envoy’s device has several advantages over typical hearing aids, including that there are no batteries to replace, the internal battery lasts for 9 years, there is no external hearing aid, and there is no feedback from the microphone. In July, the FDA approved an implantable telescope developed by VisionCare Ophthalmic Technologies, Inc. The device in intended to improve vision in patients suffering from macular degeneration or high-resolution vision loss, found in 500,000 people in the United States. According to Dr. Solari, the only treatment for macular degeneration involves external devices that provide an enlarged camera. In one trial, the implantable telescope studied 206 eyes.

The results showed that 90% of the eyes demonstrated vision improvement by 2 lines of vision on an eye chart, 60% improved by 3 lines, 40% improved by 4 lines, and 20% improved by 5 lines. The FDA also approved AlloMap Molecular Expression Testing, a noninvasive, multigene molecular diagnostic blood test that helps physicians identify the absence of heart transplant rejection. Each year, there are 2000 heart transplants in the United States. A heart biopsy is typically performed after the transplant. Dr. Solari cited a study involving AlloMap Molecular Expression Testing that evaluated 7370 genes split in 2 groups: using gene expression profiling or using routine endomyocardial biopsies. There were 409 biopsies performed in the gene-profiling group and 1249 in the other group. The test also found 11 genes that indicated rejection of the heart transplant when the gene was expressed but that indicated the rejection was not occurring when the gene was not expressed.