A pair of Connecticut medical device firms won regulatory nods in the U.S. and Europe.
SurgiQuest Inc. won 510(k) clearance from the Food & Drug Administration for its new line of 5mm AnchorPort laparoscopy trocars and Vascular Insights LLP landed CE Mark approval in Europe for its ClariVein Occlusion Catheter.
SurgiQuest touts its device’s ability to adjust for differences in each patient, calling it "the world’s first elastomeric single incision laparoscopy kit."
The Orange, Conn.-based surgical device-maker said the kit has an "integrated elastomeric, stretchable cannula system that goes in elongated and self adjusts to accommodate the patient’s abdominal wall thickness," which, according the company, reduces the chances of the device coming loose during surgery.
Early in 2009 SurgiQuest inked a deal with Intuitive Surgical Inc. (NSDQ:ISRG) to incorporate its AirSeal technology into a disposable laparoscopic access system for use with Intuitive’s robotic surgery device. In February, the company drummed up $14.5 million in new backing from 11 un-named investors.
Madison, Conn.-based Vascular Insights’s ClariVein device is designed to treat “incompetent veins” using an infusion catheter to irrigate sites in blood vessels before vascular surgery to repair the vessel. The company said early results suggest that the device is as affective as radiofrequency or laser therapy treatments, but requires less time, maintenance and electrical power. In April, Vascular Insights announced successful results from a clinical trial examining the use of the ClariVein catheter in treating varicose veins.