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El denervation renal podía ser un cambiador del juego, demanda informe

por Loren Bonner, DOTmed News Online Editor | March 28, 2013
Cardiovascular technology is one area in health care that's exploding with innovation as device manufacturers figure out better ways to deliver patient care. Cardiovascular technology is also a service line that has a large impact on hospitals' supply chain budgets. Twice a year, the supply chain company Novation publishes a report that highlights promising new technologies and trends in the cardiovascular field. Information is based on key industry meetings attended by Novation staff. These include the Society for Thoracic Surgery (STS), American College of Cardiology (ACC), Heart Rhythm Society (HRS), EuroPCR, Vascular Interventional Advances (VIVA) and Trans-catheter Cardiovascular Therapeutics (TCT).

Here are some highlights from the report.

Renal denervation technology will be a game changer

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Although no renal denervation device has yet been approved by the U.S. Food and Drug Administration, the technology is positioned to have a big impact on the market.

"Based on the clinical and statistical data available to date, and given the sheer number of potential patients with uncontrolled hypertension as well as the ongoing costs associated with treatment of chronic hypertension, we believe renal denervation technology (when approved) shows all of the signs to be a true game changer," David Richman, vice president of sourcing operations and physician preference at Novation, told DOTmed News.

Renal denervation is used to lower blood pressure through a catheter-based device by applying radiofrequency pulses to the renal arteries. Several manufacturers are currently seeking FDA approval for their renal denervation devices, and many of the clinical trials look promising, according to Richman.

In fact, the FDA and the Centers for Medicare and Medicaid Services announced on March 6 that they accepted the inclusion of Medtronic's Symplicity renal denervation system for treatment-resistant hypertension in their parallel review program. This means that simultaneously, CMS will consider the device for national coverage determination while the FDA completes its review of safety and efficacy.

Mitral valve replacement next?

According to Richman, the area of mitral valve repair has been overshadowed by aortic valve development. Last week, an FDA panel voted 5-3 in favor of Abbott Laboratories' MitraClip, an implantable mitral heart device, although a narrow margin vote claimed there was not a “reasonable assurance” that it was effective. The device is meant to treat patients with mitral regurgitation who are too at-risk for open mitral valve surgery.

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