According to a recent study published in the Journal of the American Medical Association (JAMA), U.S. heart failure hospitalizations among Medicare beneficiaries declined by nearly 30 percent from 1998 to 2008. However, while improvements in disease management may be attributed to the decline in admissions, comparable improvements were not realized for patient mortality.
Heart failure hospitalizations fall, though mortality improvements still desired
Late last week, the federal Food and Drug Administration’s (FDA’s) Circulatory System Devices panel voted unanimously to recommend approval of Cook Medical’s Zilver PTX drug-eluting stent (DES). If approved, the Zilver PTX would become the first DES available in the U.S. for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery.
Novel Peripheral DES Passes Key FDA Test
The FDA and CMS have announced a voluntary “parallel review” pilot program, aimed at decreasing the lag time between FDA approval and actual reimbursement for medical devices. Traditionally, the agencies have engaged in two separate processes; while the FDA’s stamp of approval signals the device to be “safe and effective” and serves as a win for manufacturers, without the issuance of a coverage determination from CMS, there is little hope for widespread adoption of the technology. And lag times between the two approval processes can be significant.
Parallel review to speed reimbursement for medical devices