FDA clears Hansen’s Magellan eKit for 3rd-party caths

Hansen Medical (NSDQ:HNSN) said today it won FDA 510(k) clearance for its Magellan Robotic Catheter eKit which allows operators to control 3rd party microcatheters through the robotic system.

The approval comes at least partly based on cases performed with the eKit during the Embolization Procedures in Peripheral Vasculature clinical study, Mountain View, Calif.-based Hansen Medical said. During the study, several prostate artery embolization and uterine artery embolization procedures were performed using the eKit, the company touted.

“We are proud to continue to offer advances in our portfolio of robotic catheters. We have seen strong robotic procedure growth, particularly in men’s health, women’s health and cancer treatment, since the introduction of the Magellan Robotic Catheter 6Fr, and we expect that the development of the Magellan Robotic Catheter eKit will continue to expand our presence within the Interventional Radiology space. We have placed a heavy focus on advancing our Magellan technology to enable robotic control of smaller catheters and look forward to the benefits that these added robotic capabilities will offer to patients and physicians,” CEO Cary Vance said in a press release.

The Magellan system drives Magellan robotic catheters and guide wires in minimally-invasive endovascular procedures and can be controlled remotely to allow for the use of interventional fluoroscopy during the procedures with lower amounts of radiation exposure, Hansen Medical said.

“The new Magellan Robotic Catheter eKit is a big step forward for our robotic vascular procedures. With the added robotic capabilities, we will be able to work outside of the radiation zone throughout more of the procedure and will be able to extend the stability and precision of robotic technology to the smaller microcatheters during our procedures,” Dr. Ripal Gandhi of Florida’s Miami Cardiac & Vascular Institute said in prepared remarks.

Yesterday, Hansen Medical released data from a study involving the use of its Sensei X robotic navigation system during pulmonary vein isolation procedures, touting a 100% procedure success rate, a high freedom from recurrence rate after 1 year and reduced fluoroscopy times.

Data from the study was published in the Journal of Cardiac Electrophysiology, the company said.

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