Healthcare Industry News: U.S. Food and Drug Administration
News Release - November 5, 2018
CMS Grants Outpatient Pass-through Payment to the remedē(R) System for the Treatment of Central Sleep ApneaPass-through Payment to Provide Additional Medicare Reimbursement for the remedē System
MINNETONKA, Minn., Nov. 5, 2018 -- (Healthcare Sales & Marketing Network) -- Respicardia, Inc. announced today that the Centers for Medicare and Medicaid Services (CMS) has approved an outpatient Transitional Pass-through Payment for the remedē® System, an implantable device that uses phrenic nerve stimulation to treat central sleep apnea. This announcement follows the CMS New Technology Add-on Payment (NTAP), granted to the remedē System in August, for procedures performed in an inpatient setting.
Transitional Pass-through Payment is a Medicare program designed to supplement the payment for innovative medical technologies that substantially improve the diagnosis or treatment of a disease in outpatient settings. The Pass-through Payment program will provide hospitals with additional reimbursement and will become effective on January 1, 2019.
"We are very pleased that CMS will extend supplemental reimbursement of the remedē System into the outpatient setting. The majority of remedē System procedures are performed in the outpatient setting, so we expect that this payment will provide substantial support to implanting centers," said Peter Sommerness, President and CEO of Respicardia. "Equally important, we are pleased that CMS again recognized the remedē System as a substantial clinical improvement in the options available for the treatment of central sleep apnea. We are grateful to CMS for its pivotal role in supporting the accessibility of new technologies through improved reimbursement."
About Central Sleep Apnea (CSA) and the remedē® System
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing.
The remedē System is a breakthrough, implantable system that treats the harmful effects of CSA by restoring a more normal breathing pattern during sleep. The remedē System pivotal clinical trial, published in The Lancet, demonstrated that transvenous neurostimulation with the remedē System can significantly reduce the severity of CSA, improve sleep, and improve both quality of life and patient satisfaction. Recently published data in the American Journal of Cardiology demonstrates continued, long term efficacy of the therapy.1,2
The remedē System received U.S. Food and Drug Administration (FDA) approval in October 2017 and is commencing market release in a limited number of centers in the United States and Europe.
Respicardia is a leader in innovative technologies that address the unmet needs in respiratory and cardiovascular disease with safe and effective therapies. Founded in 2006 and headquartered near Minneapolis, Minn., Respicardia is dedicated to improving patient outcomes, quality of life and overall cardiovascular health via novel transvenous neurostimulation therapies. Learn more at www.respicardia.com.
Important Safety Information
The remedē® System is indicated for moderate to severe Central Sleep Apnea in adult patients.
Your doctor will need to evaluate your condition to determine if the remedē System is right for you. You will not be able to have an MRI or diathermy (special heat therapies) if you have the remedē System implanted. The remedē System may be used if you have another stimulation device such as a heart pacemaker or defibrillator; special testing will be needed to ensure the devices are not interacting.
As with any surgically implanted device, there are risks related to the surgical procedure itself which may include, but are not limited to, pain, swelling, and infection.
Once the therapy is turned on, some patients may experience discomfort from stimulation and/or from the presence of the device. The majority of these events are resolved either on their own or by adjusting the therapy settings. The remedē System may not work for everyone. There are additional risks associated with removing your system. If you and your doctor decide to remove the system, another surgery will be required.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the remedē System. Rx only. For further information, please visit www.respicardia.com, call +1-952-540-4470 or email email@example.com.
- Costanzo M, et al. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. The Lancet. 2016; 388: 974–82
- Costanzo M, et al. Sustained Twelve Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. Am J Cardiol. 2018. pii: S0002-9149(18)30258-3. doi: 10.1016/j.amjcard.2018.02.022.
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