Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic's Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their drawing boards to redesign their plans to bring these devices to the US market.
Earlier this week Medtronic disclosed in its quarterly report that it planned to soon submit to the FDA its application for an investigational device exemption (IDE) for its next generation renal denervation device. The spiral-shaped device has multiple electrodes and is designed to achieve more comprehensive ablation of the renal arteries. The company is seeking FDA approval to proceed with a phase II trial.
In its quarterly report Boston Scientific said it plans to begin enrolling patients in the first half of this year in a phase II trial, called REDUCE-HTN REINFORCE, testing its Vessix platform . The company has not yet released details of the protocol but said the FDA has approved the protocol.
Pivotal trials for the new generation of devices probably would not be able to get underway until 2016 at the earliest.
