Valve trial gets a boost
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences gets conditional FDA approval to enroll patients receiving its Sapien transcather heart valve by an alternative delivery technique in its ongoing PARTNER trial evaluating the less invasive valve against open-heart valve surgery and medical management. The firm had already announced in December a verbal agreement with the agency to begin enrolling patients getting the device by the "transapical" approach via the rib cage in addition to the initially approved "retroflex" delivery through the leg arties (1"The Gray Sheet" Dec. 17, 2007, p. 10). Trial investigators have cited the limitations on delivery technique as a major factor in enrollment delays. Edwards also received conditional approval to enroll an additional 440 patients for a total of 1,040, the firm said Jan. 29
You may also be interested in...
Earnings In Brief
Edwards Lifesciences: Sales of Sapien transcatheter aortic heart valves in Europe reach $2 million in the fourth quarter of 2007 and will increase to $20 million in 2008, CEO Michael Mussallem reports Feb. 5. The device gained a CE mark clearance last September and is in clinical trials in the U.S. (1"The Gray Sheet" Feb. 4, 2008, In Brief). Edwards' overall heart valve sales of $131.4 million for the quarter were up 9% from a year ago, led by a "strong" international performance. Critical care segment sales grew 20% to $113 million, led by the FloTrac cardiac output monitoring system. Corporate sales of $293 million were up 10.3% from the fourth quarter of 2006
Edwards Redesigns PARTNER Trial, Pushes Back Sapien Approval Timeline
Edwards Lifesciences has reached a verbal agreement with FDA on an amended design for the PARTNER trial of its Sapien transcatheter aortic valve, the company announced during its Dec. 7 2007 investor conference
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”