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| St. Jude Medical is eyeing FDA approval with a new study of EnligHTN.--Courtesy of St. Jude |
St. Jude Medical ($STJ) is nipping at Medtronic's ($MDT) heels in the race to cash in on renal denervation, launching a large-scale study to win FDA approval for EnligHTN.
The company won the agency's blessing to launch its 590-patient EnligHTN IV trial, studying how the company's nerve-deadening device works on hypertension sufferers with systolic blood pressure of at least 160 mmHg despite drug therapy. St. Jude is enrolling at 80 sites around the U.S. and Canada, planning to amass enough data to secure FDA approval down the line.
St. Jude lags behind Medtronic, which last month completed enrollment of an FDA-OKed trial for its Symplicity device and expects to win approval in 2015, but St. Jude believes EnligHTN's benefits will give it a shot at leading the much-hyped renal denervation market when it gets on U.S. shelves.
In earlier studies, the two devices have lowered systolic blood pressure by around 30 mmHg after one year, but where EnligHTN stands out is in patient convenience and ease of use, St. Jude said. Symplicity is a single-electrode device with an average procedure time of 38 minutes, but EnligHTN's multi-electrode basket allows it to do the same job in 12 minutes, St. Jude claims, making a meaningful difference for physicians and patients.
The FDA-targeted study is St. Jude's fifth for EnligHTN, including the original pilot study, another involving patients with less severe hypertension, one of a second-generation device and, finally, the EnligHTNment study, which tests how well renal denervation can prevent major cardiovascular events like heart attack and stroke.
St. Jude touts EnligHTNment as the first large study of renal denervation's benefits outside of hypertension, and company Cardiovascular President Frank Callaghan said its results could advance the treatment's indications around the globe, making it the standard of care for the world's millions of hypertensive patients.
- read the announcement
Special Report: Renal denervation: Medtronic, St. Jude vie for lion's share of billions