The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News. Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved […]
Society of Thoracic Surgeons
Medtronic touts study data for thoracic aortic stent
Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study. The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented […]
Sunshine laws need to do more to protect docs’ reputations, health groups say

A clutch of health care groups pushed back against the current format of the Physician Payment Sunshine Act, warning that the rule doesn’t do enough to protect the reputations of physicians in case of a dispute, according to a letter obtained by MassDevice.
Nearly 100 health care groups, including the American Medical Assn. and the Society for Vascular Surgery, urged the U.S. Dept. of Health & Human Services to make changes to the measure, which will require health care providers to report all payments made to physicians and teaching hospitals to a public database.
The TAVI learning curve and the “valve-on-a-stick” approach

Clockwise from top left: Medtronic’s CoreValve, Edwards Lifesciences’ Sapien, St. Jude Medical’s Portico
As thoracic surgeons and industry representatives from all over gathered at the 2012 Society of Thoracic Surgeons meeting in Chicago last week, the transcatheter aortic valve implantation research was the belle of the ball.
Medicare proposes TAVI reimbursement guidelines
Updated 12:10 p.m. with comments from Edwards Lifesciences.




Clockwise from top left: Medtronic’s CoreValve, Edwards Lifesciences’ Sapien, St. Jude Medical’s Portico
The Centers for Medicare & Medicaid Services released a proposal detailing guidelines for reimbursement of transcatheter aortic valve implantation procedures for treating severe symptomatic aortic stenosis.
Medicare proposes TAVI reimbursement guidelines
Updated 12:10 p.m. with comments from Edwards Lifesciences.




Clockwise from top left: Medtronic’s CoreValve, Edwards Lifesciences’ Sapien, St. Jude Medical’s Portico
The Centers for Medicare & Medicaid Services released a proposal detailing guidelines for reimbursement of transcatheter aortic valve implantation procedures for treating severe symptomatic aortic stenosis.