|Mercator's micro-infusion catheters got a CE marking.--Courtesy of Mercator|
California delivery-device outfit Mercator MedSystems got the OK from European officials to launch two of its micro-infusion catheters, which use tiny needles to deliver drugs directly across artery walls.
Mercator's Bullfrog and Cricket micro-infusion catheters, for peripheral and coronary arteries respectively, have already netted 510(k) clearance from the FDA. The recent CE mark is specifically for peripheral artery disease, which affects about 23 million people in Western Europe and another 17 million or so in the U.S.
The catheters inflate in the blood vessel and then deploy a tiny needle into the vessel wall. The idea is to deliver drugs via an "outside-in" approach, according to the company, diffusing the drugs throughout the vessel's outer wall, or adventitia, cylindrically and allowing for full exposure to the drug.
Mercator is looking for drug candidates for its catheters--in preclinical trials, they showed a 75% reduction in restenosis when used with an estradiol formula. The micro-infusion devices proved to be useful in curbing the inflammatory responses in blood vessels after an angioplasty or atherectomy.
"By leveraging the adventitia's biological properties, our game-changing technology minimizes drug dilution in the bloodstream as well as complications associated with systemic administration," Mercator President Kirk P. Seward said in a statement. "This significantly reduces the inflammatory cascade, drug side effects and healthcare costs, while vastly improving therapeutic effectiveness and patient outcomes."
- here's the release