News & Insights

TCT kicked off its Innovation Summit with a provocative hook: When Disruption Meets Reality.

The session was designed to borrow from lessons in innovation to understand the future of MedTech.

As you can imagine, AI and robotics factored heavily into the conversations and presentations.

Renal Denervation led the presentation with historical context provided by Ardian founder (and fellow Aussie) Andrew Cleeland.  His Think Tank (Fogarty) sponsored the session.

Underlying this story was an audience response survey (expect to see more of those in these articles).  “What is the biggest challenge preventing widespread adoption of renal denervation?

The audience responded: Reimbursement & cost barriers.

Cleeland offered his original “Innovator’s Vision” : ‘Is there a problem to solve and is it worth solving?’.  Answer: HBP is a compelling unmet need. 

• Globally >1 billion suffer from hypertension

• More than half go untreated  

Potential cause to address: Chronic activation of the sympathetic nervous system, e.g., high blood pressure is ONLY possible when the kidneys are involved (they talk to one another!).  More than 70 years of research into HBP provided a window into this observation since addressing the kidneys was used as a CONTROL in prior HBP drug treatments.

Medtronic SVP & President Coronary & Renal Denervation Jason Weidman picked up where Cleeland left off since Medtronic purchased Ardian in 2010 (expecting FDA approval and clearance by 2013).  The FDA approved Ardian in 2023 – so what took a decade more than they anticipated?

Omar Istek, former Medtronic CEO:

“That’s why it’s called a clinical TRIAL not a clinical GUARANTEE” -!

To date, HBP was a chronic condition treated solely with drugs/pharma intervention.

Panelist Dr Frank Litvack chimed in:

“We need a radical re-think about how we regulate and approve medical devices and renal denervation is The Poster Child for this.  It should not take 20 years to pass through a regulatory process, let alone a reimbursement process.  Today, technology enables us to learn 10x more 5x faster. Of course, safety can never be compromised, but after two decades, the only products left standing have been picked up by strategics who can afford to wait that long or pour that much into a device.”

Moderator Joe Mullings said,

“Innovation is not a straight line, but strategics are built for straight lines. This kind of thinking stifles innovation.”

The panel agreed: technologies that hold promise to serve large patient populations cannot (should not) be held to a 20-year bar when they are not in market and cannot evolve. All other devices started somewhere and improved over time.  Technologies like renal denervation cannot evolve sitting on the sidelines.