Two top medical device companies turned up the heat on the renal denervation competition. Both Boston Scientific (BSX) and St. Jude Medical (STJ) delivered promising results from studies on their two respective renal denervation technologies at the Transcatheter Cardiovascular Therapeutics conference in San Francisco. Such technology uses radiofrequency ablation on the nerves leading to the kidneys to help control drug-resistant hypertension.
“In the REDUCE-HTN study, 85 percent of patients treated with the Vessix System experienced a clinically meaningful decrease in blood pressure,” Horst Sievert, director of the CardioVascular Center Frankfurt and principal investigator in BSX’s REDUCE-HTN clinical program, said in a press release. “In my opinion, the large patient cohort and rigorous analysis of the study suggest that renal denervation using bipolar technology will be an important part of the treatment algorithm for a wide variety of patients with resistant hypertension.”
After 12 months, the company claims there was a “clinically meaningful decrease in office systolic blood pressure” in 85 percent of the 139 patients treated. BSX said in a company statement Vessix is “the only renal denervation system to utilize bipolar energy to disrupt these nerves, providing a more localized and precise approach.” It boasts a 30-second treatment time.
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“Convincing clinical evidence continues to emerge that supports the benefits of renal denervation in improving systolic blood pressure for patients with drug-resistant hypertension,” Stephen Worthley, from St. Andrew’s Hospital in Adelaide, Australia, a primary investigator in STJ’s EnligHTN I trial who delivered the findings at TCT, said in a press release. “The 18-month results of the EnligHTN I study point to an overall reduction in hypertension, which is important as even modest improvements can have significant health benefits for patients who live with this life-threatening condition. This also supports that the early reduction in blood pressure remains sustained out to 18 months, confirming the durability of this procedure using the EnligHTN catheter.”
At 18 months, 77 percent of the 46 patients treated with St. Jude’s technology had responded to therapy. The latest EnligHTN system uses a multi-electrode catheter to ablate the nerves, reducing total ablation time to about four minutes, according to a company statement.
Both devices have the CE Mark. The Vessix System also has a TGA approval. Neither device is yet available in the U.S.
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