Cook's retrievable celect vena cava filter minimises risk of pulmonary embolism without making permanent filter implantation a necessity
Cook has received CE marking approval for its newest generation of retrievable vena cava filter.
The approval allows the distribution of the Celect retrievable vena cava filter in the European Union and other countries that recognise the CE mark.
"This development puts Cook squarely on track to be the world's major innovator and developer of the newest generation of retrievable vena cava filters," reports Bruce Fleck, global product manager for Cook's diagnostic and interventional products business unit.
Earlier this year, Cook's Celect vena cava filter set, a second-generation filter design based on Cook's proven Gunther Tulip vena cava filter, earned its first major regulatory approval for commercial use in Canada.
In another significant clinical milestone, Australian physicians successfully retrieved a Celect filter 62 days after implantation in a young trauma patient whose risk of embolisation had lessened sufficiently to allow the filter to be removed.
That case was the first in Cook's international clinical investigation of the Celect filter.
Later this year, a regulatory submission for US approval is planned for the device, which is an investigational device not for sale in the United States.
"The Celect filter design builds upon the proven strengths of the Cook Gunther Tulip filter, while making clinically valuable changes to the filter design.
"With these changes, the Cook Celect filter offers physicians improved centering in the vessel and reduced endothelialisation of the filter except at the desired attachment points to enhance its retrievability over extended periods," Fleck said.
A vena cava filter is an expandable metal device deployed through a catheter within the vena cava, the major blood vessel that returns blood to the heart and pulmonary system.
Once in place, the filter opens, allowing it to trap potentially fatal blood clots from moving into the pulmonary system.
Raman Uberoi, John Radcliffe Hospital in London, said: "I am very much looking forward to trialling the Cook Celect filter.
"It builds on the foundations of a excellent design of the Tulip IVC filter and potentially is a huge advance in the management of thrombo-embolic disease".
Cook's new Celect filter has been engineered to allow retrieval of the filter after greater lengths of time than was previously possible with the Gunther Tulip filter.
In animal trials, the Celect filter has been retrieved without difficulty or complication after being implanted for more than one year, which may prove beneficial to human patients whose risk of pulmonary embolism has lessened sufficiently over time to allow the filter to be removed.
