MASSDEVICE ON CALL — A group of cardiologists is taking a hard stance against renal denervation, calling for medical device manufacturers to stop selling the technology as a treatment for hypertension.
Their comments are the latest attack on the technology following disappointing results from Medtronic’s (NYSE:MDT) high-profile SYMPLICITY HTN-3 clinical trial, which found no evidence that the minimally invasive procedure helps lower blood pressure.
"I think sales should be suspended," Cleveland Clinic cardiology chief Dr. Steven Nissen told Reuters. "You (now) have a trial with no evidence it works," he told Reuters.
Other doctors similarly called for a stay on sales, suggesting that perhaps new studies may focus on teasing out which patients may actually benefit from renal denervation, a procedure that damages renal nerves believed to be associated with high blood pressure.
"A few patients seem to have derived benefit from this type of intervention," American College of Cardiology president Dr. Patrick O’Gara told the news wire. "We need to convene a group of experts to weigh the positives and negatives of a moratorium."
Other doctors questioned the study itself, pointing out potential flaws in the trial protocol and voicing concerns that the procedures may have been done improperly, Reuters wrote.
Medtronic earlier this month released full results from the highly anticipated clinical trial, reporting that denervation resulted in paltry improvements in blood pressure when compared with a sham procedure. The study was the most rigorous yet to test the technology, and the meager improvements in denervation patients weren’t statistically significant.
Lead investigator Dr. Deepak Bhatt said during the conference that even he would "be cautious about offering the procedure to patients in the face of a large, randomized clinical trial."
Medtronic said earlier this month that it consulted an independent panel of experts, which approved the company’s plans to shut down the SYMPLICITY HTN-4 trial, which Medtronic suspended along with trials in India and Japan in January. The Symplicity RDN treatment for hypertension will still be offered in jurisdictions where it’s approved and Medtronic will continue to enroll patients in a global registry, the company said.
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