|Medtronic's Symplicity--Courtesy of Medtronic|
Medical device companies with renal denervation platforms are facing yet another obstacle, as U.S. and European heart doctors are calling for a decrease or halt in the use of the devices to treat high blood pressure.
The physicians' opinions stem from troubling trial data that was presented at the American College of Cardiology (ACC) annual meeting on March 29, which showed that Medtronic's ($MDT) Symplicity renal denervation device failed to lower blood pressure more than a sham procedure in a 364-patient study. The company's renal denervation devices are available in more than 80 countries but are not approved in the U.S.
Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, told Reuters that sales should be suspended for all renal denervation products, not just Medtronic's device. "You (now) have a trial with no evidence it works," he said.
Other physicians called for a moratorium or formal review of the devices, especially in European markets where renal denervation products are widely available. The European Society of Hypertension recommended "further studies of high scientific caliber" on the devices' efficacy, Reuters reported.
"European colleagues would be better off doing the right clinical trials and perhaps putting a short-term moratorium on making (them) available, except to participate in a clinical trial," Dr. P.K. Shah, a cardiologist from Cedars-Sinai Medical Center in Los Angeles, told the news outlet.
The physicians' views present more bad news for Medtronic, which has recently faced its fair share of problems related to its renal denervation device: In January, the company announced that its market-leading product failed to meet its primary efficacy endpoint in a pivotal 535-patient trial designed to win FDA approval. The news came as a blow to Medtronic, as the company had planned on securing FDA approval for its Symplicity product by the end of 2015.
"We see it as a significant delay that (takes things) back to square one," Medtronic CEO Omar Ishrak told FierceMedicalDevices in a January interview.
The latest trial data also casts a dark cloud over sales and marketing for renal denervation devices. Wall Street analysts had estimated a potential market of $3 billion for devices made by companies such as Medtronic, Boston Scientific ($BSX) and St. Jude Medical ($STJ), but disappointing clinical trial data could make those numbers unattainable. Medtronic expects sales of only about $20 million in 2014, Reuters reported.
"This certainly set the field back several years," Jefferies analyst Raj Denhoy said about Medtronic's failed study (as quoted by Reuters). "There are no prospects of a device getting approved in the United States anytime soon."
Despite recent setbacks, Medtronic plans on working with the FDA on future renal denervation studies, the company told Bloomberg in an interview at last week's ACC meeting.
"We will commit to doing another trial in collaboration with the FDA as long as all of the signals we are looking at continue to be positive," Nina Goodheart, general manager of Medtronic's renal denervation group, told Bloomberg. "I'm not saying we will start a U.S. trial tomorrow. It takes time to get it going and we want to understand what happened with this trial."