News

Paion AG initiates Phase II trial of remimazolam for Anaesthesia

Paion AG will conduct a Phase II trial with short acting anaesthic/sedative remimazolam in general anaesthesia in cardiac surgery in the second half of 2013.Ono Pharma have completed a successful Phase II trial for remimazolam in Japan in general aneasthesia and are conducting a Phase II/III trial.

The clinical studies performed with remimazolam comprise four Phase I and three Phase ...

Merck Inc re-files sugammadex at FDA

Merck Inc., has announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection ,(known as Bridion in Europe), has been accepted for review by the FDA. Merck expects the FDA’s review to be completed in the first half of 2013.

Sugammadex sodium injection is an investigational agent for the reversal of neuromuscular blockade ...

Endurant AAA Stent Graft System(Medtronic) two year results

Medtronic Inc.has announced the two-year results from its U.S. clinical study of the Endurant AAA Stent Graft System for Abdominal Aortic Anuerysm. Presented at this year's Charing Cross International Symposium in London, the prospective Endurant U.S. investigational device exemption (IDE) study's complete results at two years continue to demonstrate durable clinical performance with strong safety and efficacy in long-term follow-up. ...

FDA approves HeliFX Aortic Securement System (Actus Endosystems) for treating aortic endografts

The FDA has given 510(K) approval for the HeliFX Aortic Securement System, from Aptus Endosystems, the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large Aortic Aneurysm. The HeliFX Aortic Securement System is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. ...

FDA approves Ovation Abdominal Stent Graft System (Trivascular) for Abdominal Aortic Aneurysm patients

The FDA has approved the Ovation Abdominal Stent Graft System, from Trivascular, which provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening Abdominal Aortic Aneurysms. Such aneurysms can be repaired through open surgery or less invasively using a stent graft. However this treatment depends on the patient’s anatomy. A small number of people ...