The FDA today issued a final order lowering the risk classification for pancreatic drainage stents at the request of device maker Xlumena.
The FDA agreed that Class II special controls are sufficient to ensure that new devices are safe and effective, taking pancreatic stents off of the more-stringent premarket approval system.
Xlumena won FDA approval to market its Axios stent and delivery system, landing approval through the FDA’s less-stringent de novo review pathway.
The stent is the 1st specifically designed for the drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
Xlumena said it closed a $25 million Series C round it plans to use to expand its commercial footprint and win FDA clearance for its Axios stent and delivery system.
Xlumena closed a $4.8 million debt and securities round with 10 unnamed investors.
Founded in 2007, the Mountain View, Calif.-based company makes ultrasound-guided interventional microscopes, including an FDA-cleared pancreatic cyst access device called Navix.
Xlumena is wrapping up clinical trials to support a 510(k) application for its Axios stent and delivery system, also to treat pancreatic cysts.
Four medical device companies reeled in more than $70 million in recent weeks, to develop technologies including a laser scalpel for minimally invasive surgeries, a peripheral vessel stapler, a thermal ablation system and a biliary stent.
Cambridge, Mass.-based OmniGuide led the charge with a $35 million round from Orbimed Advisors. OmniGuide chairman Yoel Fink told MassDevice.com in 2010 that the device uses the mirror technology he pioneered at the Mass. Institute of Technology in the 1990s.
Abbott Laboratories (NYSE:ABT) won aproval from the FDA for expanded use of its RX Acculink carotid stent system.
The expanded indication means the stent system can be used to treat carotid artery disease patients who have a standard risk for complications from carotid endarterectomy surgery, a procedure that entails cutting open a patient’s neck artery and scraping out blockages.
Personalized medicine firm MDxHealth SA (BSE:MDXH.BR) and its research partner NovioGendix B.V. won a $1.1 million grant to support the research and development of a new bladder cancer diagnostic.
The funding came from Eurotrans-Bio, a European Commission initiative that supports biotech R&D between companies and academia.