Cook Medical has received FDA clearance for its Evolution duodenal controlled-release stent to help patients experiencing issues associated with malignant gastric outlet obstruction, a late-stage complication of a number of GI-related cancers.
Evolution is the only duodenal stent delivery system that allows for controlled release and recapturability and offers patients a minimally invasive alternative to relieve potentially life-threatening complications resulting from duodenal obstruction, such as abdominal pain, vomiting, malnutrition and aspiration, the company says in a statement.
In a European study, 21 of 23 patients had significant improvement of symptoms. The same number could tolerate oral intake with a significant improvement of the gastric outlet obstruction scoring system score. Doctors have completed enrollment of 110 patients in a separate ongoing prospective multicenter study and final analysis of data is under way.
The company has expressed enthusiasm at the stent's potential. "The Evolution duodenal stent provides physicians with highly accurate stent placement, reducing the risk of migration, perforation and minimizing the need for repeat procedures," said Barry Slowey, global business unit leader for Cook Medical's Endoscopy division, in a statement. "We're excited to be expanding our line of Evolution stents by bringing to the U.S. market a stent platform that aids physicians and has been available globally for several years. This stent has been used to treat thousands of patients around the globe, potentially improving quality of life for these patients, and hopefully minimizing the painful symptoms associated with this disease."
News of the clearance comes days after the company won an FDA panel's unanimous backing for Zilver PTX, a drug-coated stent to treat blocked femoral arteries. The device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg.
The company now awaits action by the FDA on the stent, which won CE Mark approval in 2009. Currently, the stent is available for sale in 48 countries, including the U.K., Germany, France, Brazil, New Zealand and Taiwan, according to a company statement.
Peripheral vascular devices generated $4.3 billion in worldwide revenue last year and may earn $5.6 billion in 2014, according to market research firm Technavio, as quoted by Bloomberg.
- check out the Cook Medical release
- read the release on the Zilver PTX meeting
- see the Bloomberg report