An Irish medical technology firm has developed a breakthrough device that will propel the company to tap into a US$1bn market. Its first product will launch in the European market in the first half of 2010.
Dublin-based Vasorum Ltd, which specialises in the interventional cardiology and radiology markets, will present the initial results of its First-in-Man clinical study for its flagship device AstraPlug at the world-renowned TCT (Transcatheter Cardiovascular Therapeutics) in San Francisco today.
The AstraPlug system delivers a miniature medical grade biocompatible stainless steel implant which allows immediate control of blood flow on removing a catheter from the groin following minimally invasive procedures such as angiogram, angioplasty or stent placement.
European market launch for AstraPlug is anticipated in the first half of 2010.
About 10 million patients undergo cardiac and peripheral catheterisation procedures annually. This involves the temporary insertion of the catheter into an artery through a vascular puncture.
While a variety of legacy methods cause significant discomfort and require several hours of bed rest, AstraPlug was able to achieve an excellent average time to haemostasis (30 seconds) in a painless manner in the trial group.
“Results from this First-in-Man study are very encouraging,” explained Dr Niall Mulvihill, Department of Cardiology, St James’s Hospital, Dublin.
“AstraPlug achieved excellent results even in patients on anticoagulation and suffering from peripheral vascular disease. The rapid haemostasis, minimal training requirement, lack of necessity to exchange the procedure sheath and excellent patient comfort are clear advantages of using the AstraPlug device,” said Mulvihill.
CEO Dr James Coleman, R&D director Christopher Cummins and Dr Robert Perryman, CEO of AltaScience Limited, founded Vasorum Ltd in October 2005.
The trial included the AstraPlugTM device in both 5F and 6F sizes and comprised both diagnostic and interventional cases. The study has been carried out at St. James’s Hospital Dublin, by Mulvihill, Dr Peter Crean, chief Dr med Eberhard Grube and colleagues at the Helios Heart Centre in Siegburg, Germany.
“Vasorum has endeavoured to develop the ideal percutaneous arterial puncture closure device,” explained Coleman.
“We believe that this innovative technology will impact very positively on the clinical management of patients undergoing percutaneous interventional vascular procedures.”
“With the market estimated to hit US$1 billion by 2010, the health-care industry in both the US and Europe is crying out for a device such as AstraPlug which will address both hospital’s need for cost effectiveness and patient needs for a speedy recovery,” Dr Coleman added.
By John Kennedy
Photo: Vasorum Ltd’s AstraPlug system allows immediate control of blood flow upon the removal of a catheter.