Medtronic (NYSE:MDT) sought to temper the buzz around clinical findings showing rival St. Jude Medical’s (NYSE:STJ) Enlightn renal denervation system lowers high blood pressure faster than MDT’s Symplicity device.
St. Jude released 30-day data from a clinical trial showing that Enlightn lowered blood pressure by twice as much as Medtronic’s Symplicity systems in the same amount of time. Data was compared from 2 separate trials, as the devices have never gone head-to-head.
"While interesting, short-term data in a limited number of patients is typically considered hypothesis-generating," Medtronic spokeswoman Wendy Dougherty told MassDevice.com today. "Rigorous, long-term studies are needed to show whether emerging technologies meet the proven, sustained safety and effectiveness benchmark set by the Medtronic Symplicity system."
Renal denervation uses a catheter in the renal artery near each kidney to deliver radiofrequency energy to ablate the nerves that contribute to high blood pressure.
Medtronic’s Symplicity, which uses a single electrode in contrast to St. Jude’s mutli-electrode approach, is already on the road to FDA review with clinical trials approved last summer in the U.S.
St. Jude’s Enlightn, the 1st to use multiple electrodes, won CE Mark approval earlier this week in the European Union, where the company released data from the small, 30-day study at the EuroPCR conference in Paris.
In a study of 46 patients with medication-resistant hypertension, treatment with Enlightn resulted in a 28-point reduction in blood pressure after 1 month. St. Jude also pointed to findings from a Medtronic trial, published in Lancet in March 2009, in which patients treated with the Symplicity lowered their blood pressure by 14 points over the same amount of time.
That 50-patient trial treated 45 with renal denervation (5 were excluded for "anatomical reasons"). Follow-up was conducted at 1 month, 3 months, 6 months, 9 month and a year.
The 2 trials were not designed to be comparative, making any conclusions drawn by parallel problematic.
"Only Medtronic has peer-reviewed, published evidence of acute and long-term safety of our Symplicity renal denervation system with sustained performance to 3 years," Medtronic’s Dougherty told us. "Further, the Symplicity system has been safely used in nearly 5,000 patients since commercialization."
The crosstown rivals have ratcheted the competition up a notch in recent weeks, what with a quarrel over controversial findings linking St. Jude’s recalled Riata defibrillator leads to 22 deaths and Medtronic’s Quattro lead with only 5.
"I can’t recall seeing a more contentious and open dispute between medical device companies in my 19 years working in this field," Schloss, director of cardiac electrophysiology at the Christ Hospital in Cincinnati said of that kerfluffle.
The renal denervation space, already drawing immense interest and considered by some to be the top area for innovation in 2012, is also getting more crowded.
Covidien (NYSE:COV) recently vaulted into the space with the surprise introduction of its OneShot system, which also has CE Mark approval in the European Union. The OneShot system was gained through the acquisition of Maya Medical late last month in a deal worth up to $230 million.