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Medtronic Schools Us All on the Power of Persistence
This week in Pedersen's POV, our senior editor highlights a priceless lesson from a historic FDA approval.
November 27, 2023
3 Min Read
Quote graphic by MD+DI
It was a Friday night in mid-November, and I had just settled into bed with a good book, when my phone began blowing up with LinkedIn notifications. I resolved to ignore the intermittent buzzing – whatever it was could wait until Monday morning.
But the nuisance quickly escalated into a battle of wills between myself and my LinkedIn app as the number of notifications continued to climb. It was a battle I ultimately lost. My determination to not think about work that Friday night was simply no match for the persistence of my notification settings. I had to know what all the fuss was about.
The fuss, as it turns out, was very much warranted. Medtronic had just announced FDA approval for its Symplicity Spyral renal denervation system, also known as the Symplicity blood pressure procedure. It was welcome news for the millions of people in the United States living with high blood pressure. It also was a lesson in the power of persistence that the medtech industry won't soon forget.
The Symplicity system is designed to deliver radiofrequency energy to specific nerves near the kidneys that can become overactive and contribute to high blood pressure. Approval came about a week after FDA approved an ultrasound-based renal denervation technology from Recor Medical.
I've followed every twist and turn of Medtronic's renal denervation journey since the company's $800 million acquisition of Ardian in 2011, including the fateful moment in January 2014 when the company's SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint. I watched as one competitor after another dropped out of the renal denervation race. The mentality seemed to be: If Medtronic can't do it, what hope do we have?
But Medtronic persisted. The company's belief in the underlying science behind renal denervation for hypertension never wavered, at least not publicly. Not even when interim data from SPYRAL ON MED trial was deemed inconclusive and investors had mostly given up on renal denervation.
In late August, an advisory committee voted against Medtronic's renal denervation system. And yet, Medtronic remained undaunted.
I never once doubted that the technology, if approved, would fill a critical gap in the way hypertension is treated in the United States. But FDA rarely goes against a panel rejection. It's only happened six times in the past six years, according to a study published in January, and that's out of 133 meetings across all drug, biologic, and device advisory committees.
So, I began to speculate about Medtronic's future in renal denervation. If FDA rejected the Symplicity system, would Medtronic try to buy Recor? It's not the outcome I wanted to see, but it seemed a plausible theory. I've never been happier to be wrong.
Jason Weidman, head of Medtronic's coronary and renal denervation business, said it best in a LinkedIn article he published sharing the big news. "If bringing a device to treat hypertension to the largest healthcare market in the world were easy, it would have already been done long ago," Weidman wrote. "I am humbled by the work of our team at Medtronic, who for more than a decade has led the way in bringing this therapy to people living with hypertension. Your tireless dedication, commitment to our mission, and relentless pursuit of innovation have culminated in today’s milestone. We are proud of the journey we took to get here. We learned more about hypertension, renal denervation, our technology, and patient behavior through this process than we ever imagined when we first acquired Ardian more than a decade ago."
Competition breeds innovation, and innovation leads to better patient outcomes. Now, thanks to the tenacity of both Medtronic and Recor Medical, the market has not one but two renal denervation options for patients with uncontrolled hypertension. The technologies are differentiated from one another in the type of energy source they use, radiofrequency versus ultrasound.
As for those pesky LinkedIn notifications interrupting my bedtime routine that Friday night – I'm glad I didn't wait until Monday to find out what the fuss was all about. And I'll remember 2023 as the year Medtronic schooled us all on the power of persistence.
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