Renal denervation could be a game changer, claims report
March 28, 2013
by Loren Bonner, DOTmed News Online Editor
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
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.
With the exception of a single manufacturer's one trans-catheter aortic implant, which is FDA approved, all other percutaneous heart valves — aortic as well as mitral — are currently in clinical trials.
Financial impact for hospitals
TAVR, or transcatheter aortic valve replacement, involves transporting a prosthetic valve through a catheter in the leg to the heart in patients with aortic stenosis. Edwards Lifesciences received FDA approval for TAVR in November 2011, and several U.S. hospitals were part of testing the procedure in clinical trials over the past five years. Today, TAVR is performed in roughly 200 hospitals nationwide.
However, because of lag time in reimbursement from CMS, the vast majority of the hospitals performing TAVR have had negative bottom lines due to the very high cost of the actual procedure, said Richman.
Although hospitals want to adopt these more advanced technologies and surgical methods, in general, new technologies or treatment modalities are often introduced before the reimbursement models for these procedures have been determined. In addition, many of the technologies do not have available data based on long-term clinical studies to support their improvement effectiveness at the point of their introduction, said Richman.
Besides renal denervation and TAVR, drug-eluting balloon catheters, drug-eluting peripheral stents and bioabsorbable coronary scaffolding are emerging technologies hospitals should be keeping an eye on as well.
"To our understanding, it was only after the release of the Cypher Sirolimus-eluting coronary stent that CMS approved a unique reimbursement code for Johnson & Johnson. We understand that Abbott Laboratories is attempting to work with CMS to get reimbursement for their new Absorb Everolimus-eluting coronary scaffold," said Richman.
In particular, he said Abbott Laboratories Absorb Everolimus-eluting coronary scaffold has promising long-term clinical data. "The outstanding question is the ultimate price and reimbursement in the United States," he said.
Ultimately, it is too early to speculate on the ability of these technologies to improve outcomes while lowering costs — something hospitals will be more concerned about than ever in this era of health care reform. But stakeholders will certainly be monitoring those outcomes closely.
Here are some highlights from the report.
Renal denervation technology will be a game changer
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.
With the exception of a single manufacturer's one trans-catheter aortic implant, which is FDA approved, all other percutaneous heart valves — aortic as well as mitral — are currently in clinical trials.
Financial impact for hospitals
TAVR, or transcatheter aortic valve replacement, involves transporting a prosthetic valve through a catheter in the leg to the heart in patients with aortic stenosis. Edwards Lifesciences received FDA approval for TAVR in November 2011, and several U.S. hospitals were part of testing the procedure in clinical trials over the past five years. Today, TAVR is performed in roughly 200 hospitals nationwide.
However, because of lag time in reimbursement from CMS, the vast majority of the hospitals performing TAVR have had negative bottom lines due to the very high cost of the actual procedure, said Richman.
Although hospitals want to adopt these more advanced technologies and surgical methods, in general, new technologies or treatment modalities are often introduced before the reimbursement models for these procedures have been determined. In addition, many of the technologies do not have available data based on long-term clinical studies to support their improvement effectiveness at the point of their introduction, said Richman.
Besides renal denervation and TAVR, drug-eluting balloon catheters, drug-eluting peripheral stents and bioabsorbable coronary scaffolding are emerging technologies hospitals should be keeping an eye on as well.
"To our understanding, it was only after the release of the Cypher Sirolimus-eluting coronary stent that CMS approved a unique reimbursement code for Johnson & Johnson. We understand that Abbott Laboratories is attempting to work with CMS to get reimbursement for their new Absorb Everolimus-eluting coronary scaffold," said Richman.
In particular, he said Abbott Laboratories Absorb Everolimus-eluting coronary scaffold has promising long-term clinical data. "The outstanding question is the ultimate price and reimbursement in the United States," he said.
Ultimately, it is too early to speculate on the ability of these technologies to improve outcomes while lowering costs — something hospitals will be more concerned about than ever in this era of health care reform. But stakeholders will certainly be monitoring those outcomes closely.