Nicole MacMillan, Cardiovascular Roundtable
A recent study presented at the 2012 EuroPCR conference in Paris has demonstrated promising evidence in favor of CardioKinetix’s “Parachute” device, designed to segment off part of the left ventricular wall in heart failure patients. This was the first-in-human trial for the parachute device. Researchers found it significantly improved symptoms of heart failure, decreased ventricular volume, and reduced death and hospitalization for heart failure one year post-implantation.
Parachute device a promising intervention for heart failure
In breaking news this week, the Centers for Medicare and Medicaid Services (CMS) announced its final national coverage decision policy for transcatheter aortic valve replacement (TAVR) as an alternative to open aortic valve replacement (AVR) for clinically indicated patients. While considered a boon to the future of the innovative procedure, CMS has set strict hospital and operator requirements to qualify as a TAVR-performing site and receive reimbursement. Therefore, the final coverage decision will serve to effectively limit TAVR adoption to the most qualified programs and place the procedure in the hands of the most skilled operators – a policy widely accepted by regulators and professional societies alike.
CMS finalizes coverage for TAVR
An FDA advisory panel voted 7 to 1 on Thursday stating that benefits of Cameron Health’s S-ICD outweigh its risks, taking the device one step closer to FDA approval. The S-ICD is the first subcutaneous cardiac implantable device that does not require transvenous (TV) leads. While TV devices are the widely accepted standard for EP implantables, the insertion of their electrodes into the subclavian vein as well as endocardial lead placement can result in serious risks, particularly if leads require extraction. Panelists argued the S-ICD may help change the trend of under-penetration in the ICD market, attracting patients who may not normally seek a TV device.
FDA advisory panel approves subcutaneous ICD