Devices on cusp: Renal denervation, valves, stents

Renal denervation systems, percutaneous aortic valve replacement technologies and bioabsorbable coronary stents lead the pack for innovative cardiovascular devices in Novation’s spring 2013 CV Watch report.

“Each of these emerging technologies has a high probability of impacting a hospital both by enhancing patient care and increasing supply chain costs,” the authors wrote. Most of the technologies highlighted in the report remain investigational in the U.S., they noted. But interest in the U.S. cardiovascular community has been piqued by evidence from clinical trials, data from Europe where some devices received CE Mark and corporate efforts to develop and commercialize the products.

The report includes a synopsis of selected emerging technologies, their economic impact, reimbursement scenarios and key clinical findings.

Renal denervation is being proposed as a treatment for patients with hypertension who do not respond to multiple pharmaceutical therapies. The authors estimated that up to 20 percent of patients may fall into this category, and that the cost of managing treatment-resistant hypertensive patients may reach $30 billion annually.

“Should this therapy prove effective, it will have a high probability of being reimbursed quickly due to high Medicare cost savings,” according to the report.

Transcatheter aortic valve replacement (TAVR) changed practice with PARTNER trial results that showed clinically significant mortality benefits for patients with severe aortic stenosis who are deemed ineligible for surgical aortic valve replacement (the cohort B group), the analysts wrote. The FDA approved the Sapient valve (Edwards Lifesciences), and Medicare allows reimbursement. But the agencies have imposed “strict requirements” on which hospitals can implant TAVR devices.

“The result is a limitation on hospitals performing TAVR procedures and inflexibility on device pricing,” they continued.

They defined TAVR’s economic impact as significant. The economic assessment placed the cost of valve replacement at $32,000 to $32,500 (based on trial data); Medicare average payment for the procedure between $25,000 and $55,000; and mean costs at $78,542 (based on a cohort B substudy). “For many hospitals performing the TAVR procedure, these higher costs translate into flat to negative profit margins,” they wrote.

The analysts highlighted numerous other developments, including drug-eluting coronary and peripheral stents, drug-eluting balloons, bioabsorbable coronary scaffolding, left appendage closure devices, cardiovascular imaging devices and more.

The Irving, Texas-based Novation specializes in healthcare supply chains. The company said staff prepared the report after attending clinical sessions at high-impact meetings and meetings with suppliers. It added that staff members have no personal financial ties with suppliers and no conflicts of interest.