New Products In Brief

Firm gains CE mark approval and commences European launch of its EnligHTN multi-electrode renal denervation system for treatment of hypertension, announced May 15. St. Jude Medical Inc. notes that it is the first multi-electrode ablation technology available for the indication. EnligHTN is designed to deliver radiofrequency energy to create lesions along the renal sympathetic nerves, which help to regulate blood pressure, using a unique basket design generating patterns of four ablations in 90-second intervals. “Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies,” St. Jude states. EnligHTN is the fourth renal denervation product to launch in Europe, behind Medtronic’s Symplicity, ReCor Medical’s Paradise and Covidien’s OneShot, analysts note. Medtronic leads the pack, prepping for U.S. approval of Symplicity in 2014. (See Also see "With Trial Approval, Medtronic Aims For Symplicity RF Catheter Launch In 2014" - Medtech Insight, 18 July, 2011..) Industry watchers cite renal denervation as a promising new market opportunity. It “could become a billion dollar or greater market within five years and eventually become a multi-billion dollar market,” said Mizuho Securities analyst Michael Matson in a May 15 note.

Early first-in-man data from the company’s EnligHTN I feasibility study showed a 28-point reduction in systolic blood pressure after one...