Posts Tagged ‘FDA approvals’

February 23rd, 2012

FDA Grants MI Indication for Drug-Eluting Stents

Boston Scientific announced on Wednesday that the FDA had approved the use of its Ion and Taxus Liberte paclitaxel-eluting stents for the treatment of patients with MI. These are the first drug-eluting stents to receive a specific indication for MI. The new indication is based on data from the Taxus clinical program and the HORIZONS-AMI trial. […]

November 3rd, 2011

FDA Approves TAVR But Remains in the Crosshairs

I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR). The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons and […]

September 8th, 2011

FDA Advisory Panel Gives Yellow Light to Rivaroxaban

The FDA Cardiovascular and Renal Drugs Advisory Committee voted 9-2 (with 1 abstention) in support of rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in patients with atrial fibrillation, but the vote did not represent a ringing endorsement of the drug. The committee wrestled throughout the day with the numerous concerns raised by FDA reviewers, […]

September 1st, 2011

How Is TAVI Like a European Toaster?


Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the “CE mark” — a mandatory conformity stamp for products placed on the market in the European Economic Area. Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the FDA […]

July 29th, 2011

Controversial IOM Report Highly Critical of 510(k) Process

The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The […]

July 1st, 2011

Rivaroxaban (Xarelto) Gains First FDA Approval for DVT Prevention

Rivaroxaban (Xarelto, Janssen) received FDA approval today for the prevention of deep-vein thrombosis in patients undergoing knee or hip replacement surgery. This oral anticoagulant has been approved for use at a 10-mg dose, once daily, for 35 days following hip replacement and for 12 days following knee replacement surgery. The company has also submitted an application […]

May 25th, 2011

FDA Approves Xience Nano for Small Vessels

The FDA has approved the Xience Nano everolimus-eluting stent, Abbott has announced. The stent is based on the same platform as the popular Xience V stent, and can be used in vessels as small as 2.25 mm. The approval was based on results from the SPIRIT Small Vessel clinical trial. The rate of target lesion […]

April 14th, 2011

FDA Officials Offer Explanation for Absence of Low-Dose Dabigatran

Following the approval last October of dabigatran, some observers criticized the FDA’s decision not to approve the lower 110 mg dose of the drug in addition to the higher 150 mg dose. Now, in a perspective in the New England Journal of Medicine, 3 FDA officials — B. Nhi Beasley, Ellis Unger, and Robert Temple — explain […]

February 8th, 2011

FDA Approves First Pacemaker Designed For Use with MRI

The FDA has approved Medtronic’s Revo MRI SureScan Pacing System, the first pacemaker designed for safe use during MRI exams. Here is Medtronic’s description in a press release of how the pacemaker differs from traditional pacemakers: “The pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards […]

December 17th, 2010

FDA Delays Approval of Ticagrelor

Despite widespread expectations of an easy approval, the FDA has issued a complete response letter to AstraZeneca for Brilinta (ticagrelor). According to a press release from the company, the FDA has asked for additional analyses of data from the pivotal PLATO trial, but did not request any additional studies. AstraZeneca said it is evaluating the […]