|St. Jude's latest EnligHTN system faces a halted U.S. trial.--Courtesy of St. Jude|
St. Jude Medical ($STJ) may have snagged a CE mark for its next-gen EnligHTN IV renal denervation system, but a U.S. clinical trial for the device has come to a screeching halt. That means Medtronic is poised to take a bigger lead as a result.
The reason? Rather than facing any problems with safety or effectiveness, clinicians at the Minnesota device company have simply have had a hard time recruiting viable candidates for the 590-patient trial since enrollment began in June, a company spokeswoman told Medscape via email. They said they're also concerned that Minnesota rival Medtronic's competing product--which is much further along in the development process--might siphon off viable patients they need for their study.
So rather than continue, the spokesperson is quoted as saying in the story that St. Jude will essentially take a step back and regroup. The company will work with the FDA to develop a new protocol that addresses the struggle to enroll patients, she said.
The delay tips the scales toward Medtronic ($MDT), which completed enrollment in its similar U.S. Symplicity HTN-3 trial earlier this year. Medscape noted the full results are expected in early 2014. Approval is also likely by 2015, but the article tells us that with Medtronic renal denervation coming first, St. Jude had concerns that it might not be able to round up enough patients for a sham procedure if another system for treatment-resistant hypertension is already on the market.
Medtronic's Symplicity device and its next-generation iteration has a CE mark and other international approvals. And a next-generation EnligHTN won a CE mark in August 2013. They're vying for a rapidly growing market that analysts expect will hit the $3 billion mark within the next 10 years.
St. Jude has promoted its new EnligHTN as one that stands out by reducing procedure time from 24 to 4 minutes, by firing simultaneously with four electrodes to deaden nerves instead of having the four electrodes fire one after the other.
- read the Medscape story