Mercator MedSystems touted European regulatory approvals for a pair of micro-infusion catheters for the treatment of peripheral artery disease.
The San Leandro, Calif.-based medical device company received CE Mark approval in the European Union to market its Cricket and Bullfrog catheters, which are designed to inject therapeutic agents safely through blood vessel walls into deep tissues. The pair of products already have FDA clearance for the U.S. market.
"The CE Mark allows Mercator to begin changing the very nature of PAD therapy in Europe," Mercator MedSystems chairman Thomas Loarie said in a prepared release. "We are particularly excited about the great potential of our new paradigm of an ‘outside-in’ drug delivery system which can be rolled out in a variety of other applications – including hypertension, autologous stem cell delivery, bronchial therapy and lung cancer."
Peripheral artery disease or PAD is a circulatory condition, where plaque buildup in the arteries reduces blood flow to the extremities. The disease affects an estimated 1 in 20 Americans over the age of 50, according to the National Heart, Lung, & Blood Institute.