|Delcath Receives Value 4 Reimbursement Status For Chemostat; FDA Grants Pre-Market Approval for Medtronic Melody® Transcatheter Pulmonary Valve|
|By Josh Gee|
|Tuesday, 03 February 2015 19:31|
Delcath Systems, Inc. (NASDAQ: DCTH) announces that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has affirmed Value 4 coverage status for 2015 for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System.
Under the Neue Untersuchungs und Behandlungsmethoden (NUB) reimbursement scheme, Value 4 Status does not mandate reimbursement but does permit cancer centers to negotiate for reimbursement coverage for designated procedures with insurers serving their region. InEk first established NUB Value 4 status for CHEMOSAT procedures in 2013, and affirmed this assessment for 2014 and 2015. The NUB is an annual process and participating centers in Germany are required to apply each year for subsequent coverage under the scheme. The InEk determines three status levels for medical procedures submitted for its review: Value 1 (mandated reimbursement), Value 2 (declined for reimbursement), and Value 4 (negotiated reimbursement). The InEk may also decline to make a determination regarding an application.
Commenting on the announcement, Jennifer K. Simpson, Ph.D., Interim President and CEO of Delcath Systems, said, "While we are pleased to have received Value 4 coverage status again in 2015, we continue to expect the primary mechanism for reimbursement to be Individual Funding Requests (IFRs), or case-by-case appeals for reimbursement made to a patient's insurance carrier. While each IFR is evaluated independently, the majority of applications for CHEMOSAT procedures were approved in 2014, and included coverage from a range of sickness funds across a number of regions in Germany. In 2015, we expect that patients in Germany will continue to have access to treatment with CHEMOSAT via the IFR reimbursement mechanism."
Medtronic plc (NYSE: MDT), today announced that its Melody® Transcatheter Pulmonary Valve (TPV) received Pre-Market Approval (PMA) from the United States Food and Drug Administration (FDA) based on strong clinical evidence from three clinical studies demonstrating the valve's effectiveness in delaying open-heart reoperation.
The first transcatheter heart valve available anywhere in the world, the Melody TPV was originally approved in 2010 under a Humanitarian Device Exemption (HDE), a regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but do not have evidence of clinical effectiveness. PMA approval has been issued based on the robust evidence now available that supports both safety and effectiveness of the Melody TPV.
Melody TPV is a minimally invasive therapy shown to effectively prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract (RVOT) conduit caused by congenital heart disease (CHD). More than 7,300 patients worldwide have received the therapy to date, more than half of whom are children with CHD.
"The Melody valve has been a reliable option for patients suffering from CHD, and these data reinforce its strong performance since it was first introduced," said William E. Hellenbrand, M.D., chief of pediatric cardiology at the Yale School of Medicine. "This approval underscores the valve's importance in treating this small patient population, who over their lifetime will face several open heart surgeries."
The PMA approval is based on accumulated data from three clinical studies that followed a total of 310 patients implanted with Melody TPV - the Melody U.S. IDE Study, the Melody U.S. Post Approval Study (PAS) and the Melody European and Canadian Post-Market Surveillance Study (PMSS). Data showed strong valve performance in all three studies in patients implanted with the Melody valve as approximately 98 percent of patients were free from conduit reoperation (open-heart surgery) at one year post-implant. Additionally, 91 percent of patients in the IDE cohort were free from conduit reoperation at five years post-implant.
"The transition from HDE to PMA is an important regulatory milestone, which truly emphasizes the significant clinical benefit that the Melody TPV can bring to people with CHD by providing a therapy option that may reduce the number of open heart surgeries they need throughout their lifetime," said Rhonda Robb, vice president and general manager of Heart Valve Therapies at Medtronic. "Today's approval reinforces Medtronic's ongoing commitment to a congenital heart disease program by providing innovative and successful therapies to this underserved patient group."
CHD is the most common birth defect in the United States; it affects an estimated 40,000 U.S. babies each year.1,2,3 Approximately 20 percent of those infants have deformities that disrupt the blood flow from their RVOT to the pulmonary arteries.4 A subset of these children will receive a connecting conduit early in life to improve that blood flow. If a patient's RVOT conduit fails later in life but is still of adequate size to address the patient's needs (i.e., the patient has not outgrown the conduit), then a Melody TPV may be implanted to help delay a surgical pulmonic valve replacement, which is a much more invasive procedure than transcatheter valve replacement.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
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