MPO at 10: A Decade of Discovery
“We view renal denervation for the treatment of uncontrolled hypertension as one of the
most exciting growth markets in medical devices,” Sean Salmon, vice president and general
manager of Medtronic’s Coronary and Peripheral Business, said when the deal was announced.
The market also is one of the most potentially lucrative for medtech firms: Industry
analysts estimate the renal denervation sector will be worth up to $10 billion over the
next decade as the disease claims more victims. High blood pressure (readings above
140/90) currently afflicts one-third of U.S. adults and adds $51 billion in costs to the nation’s bloated healthcare system, according to American Heart Association (AHA) statistics. The AHA projects the condition to grow 7.2 percent by 2030, infecting roughly 105
About half of those with hypertension control the disease with drugs. But 10 percent
have a form of the disorder that is resistant to medication and ideally suited to the nerve-zapping procedure pioneered by Gelfand and Levin.
The duo’s technology, dubbed Symplicity by Gifford and his cohorts, consists of an
ablation catheter that resembles a motorcycle throttle and a radio frequency generator.
Doctors insert the catheter into a patient’s femoral artery and then thread it into the renal
vein; once in place, Symplicity’s radio frequency energy electrode tip performs a series
of two-minute ablations to deactivate surrounding arterial nerves (thereby ending those
flawed brain messages). The minimally invasive procedure reportedly is easier to perform
than a coronary angioplasty and currently is amassing a promising cache of clinical trial
evidence (results from Medtronic’s Symplicity HTN-2 trial showed the treatment lowered
blood pressure by -31/- 11 mm Hg).
Approved for use only in Europe and Australia, Symplicity received an Investigational
Device Exemption designation from the U.S. Food and Drug Administration (FDA) in July
2011 and is set for a U.S. launch in 2015.
Golden Age of Innovation
As a cardiologist, Levin understands the conservative nature of the medical community perhaps better than Gelfand. There was even a time he considered himself among the moderates. Thus, whenever he pitches the pair’s ideas to doctors, Levin chooses his words carefully.
“Doctors are conservative and easy to scare. So you try to build a story for them. You say,
‘No, this is not new. This has actually been known for a while ... you don’t want to say, ‘It’s
a quantum leap, a revolution,’ ” Gelfand noted in the Fast Company article.
“You want it to look incremental,” Levin added.“But it really is disruptive.”
Only time will tell whether renal denervation is the kind of disruptive technology that
rattles conservatives and delights inventors. Nevertheless, it arguably is one of the top
medtech innovations of the last decade.
The medical device industry of 2013 is a radically different beast than its 2003 incarnation. Technology has surged forward with unprecedented speed and accuracy since Gelfand and Levin’s whistle-stop tour of Valley venture capital, outdating machinery, equipment and procedures that were commonplace only a few years ago.
Knee implants, for instance, now are customized to fit specific genders, anatomies or
ethnicities, and incorporate various materials to help them better adhere to bone. Surgeries are much less invasive and performed with the help of robots; free-floating, pill-sized
cameras are exploring the vestiges of the digestive tract; and amniotic membranes are
mending eye tissue, Achilles tendons, dermal wounds and bone spurs. Even the manufacturing process has come of age: Steady streams of computer software updates have turned
product development and assembly into a digitized dream, with machines that adapt to
specific styles, remember material or process data, and detect broken tools.
“There was a significant flow of innovation back in 2003. Across the board, from cardiovascular to orthopedic to spine, 2003 to 2005 was a period of great innovation,” noted
Glenn J. Novarro, managing director, Medical Supplies & Devices at RBC Capital Markets
Corp., a global investment bank with 70 offices worldwide.“The minimally invasive spinal