Archive for July, 2009

St Jude wireless-ready pacemakers get FDA approval

St JudeSt. Jude Medical Inc has received approval from the US Food and Drug Administration (FDA) for a pair of wireless-ready pacemakers called the Accent RF pacemaker and Anthem RF CRT-P (for cardiac resynchronization therapy pacemakers). These pacemakers can wirelessly communicate with a programmer used by the clinician or a home monitor.

Boston receives FDA approval for Taxus Liberte

Boston Scientific has received the FDA approval to market its Taxus Liberte long paclitaxel-eluting coronary stent system, a next-generation drug-eluting stent designed for long lesions. At 38mm, Taxus Liberte long stent is the longest available drug-eluting stent (DES). This provides doctors with an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. The company plans to launch the product in the US in August.

FDA approves Effient for thrombotic cardiovascular

Daiichi Sankyo Inc and Eli Lilly received approval from the US Food and Drug Administration (FDA) for Effient (prasugrel) tablets to be used for the reduction of thrombotic cardiovascular events. Effient reduces thrombotic cardiovascular events (including stent thrombosis) in patients suffering from acutecoronary syndromes and undergoing an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

Cialis’ active ingredient approved for a new use

The FDA has approved tadalafil, the active ingredient in the erectile dysfunction drug Cialis, to improve exercise ability in people with pulmonary arterial hypertension, which is a rare, life-threatening lung disorder. This disorder causes high blood pressure in lungs. Tadalafil, manufactured by the drug company Lilly, will be available in the U.S. as Adcirca in August by United Therapeutics Corporation.

FDA approves Multaq for heart rhythm disorders

French drug company Sanofi-Aventis announced that the US Food and Drug Administration (FDA) had approved its heart drug and potential blockbuster product Multaq. Multaq promotes a normal heart rhythm in people with atrial fibrillation or atrial flutter. These conditions cause the heart to beat too quickly and can prevent it from pumping blood correctly.