Getting to the Heart of the 2024 Cardiovascular MarketGetting to the Heart of the 2024 Cardiovascular Market

Cardiovascular intervention is one of the largest and fastest-growing disease areas in medtech, Jennifer Kozak, vice president of new business development at Johnson & Johnson cardiovascular therapeutics, said in an interview for EY’s Pulse of the MedTech Industry Report 2024.

Report author John Babitt, EY Americas medtech transactions leader at Ernst & Young, reports lots of activity in cardiovascular—"so much so that we actually heard some companies mention there were capacity issues in the interventional cardiology suite.”

Spotlight on pulsed-field ablation

Medtronic and Boston Scientific were first to gain FDA approvals for pulsed-field ablation (PFA) technologies in late 2023 and early 2024, respectively.

Medtronic’s PulseSelect PFA was the first such system to win FDA approval in late 2023, for treating paroxysmal and persistent atrial fibrillation (AF), paving the way for rapid adoption of the technology in 2024. In October 2024, Medtronic announced approval of the Affera Mapping and Ablation System with the Sphere-9 Catheter, indicated for the treatment of persistent atrial fibrillation and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.

MD+DI reported in October that FDA approved Boston Scientific’s Farawave Nav Ablation Catheter, which integrates cardiac mapping and therapy delivery, reducing the need for multiple devices during procedures.

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And in November, Johnson & Johnson joined the PFA race with approval of its Varipulse technology.

Experts anticipate significant growth in the PFA market, comparing it to the historical competition seen in the stent market.

Valve repair innovations

In February, Edwards’ Evoque valve replacement system was the first transcatheter therapy to earn FDA approval for tricuspid valve treatment. Abbott received FDA approval for its TriClip transcatheter edge-to-edge repair (TEER) system to repair leaky tricuspid heart valves in April 2024.

Technologies to treat other heart valves also made waves in 2024.

“There are a few products that have been approved for mitral, and more are coming in tricuspid. On top of that, you had some label indication expansion in the transcatheter aortic valve replacement (TAVR) in the aortic [stenosis] space,” Babitt said. “All three of those markets should be poised for decent growth in 2024 and continued growth in 2025.”

Babitt sums it up as: Medtronic and Edwards are big players in the aortic space. The mitral space has been about Abbott, but Edwards has a play there. And, certainly, Medtronic has some products under development. And there are a number of emerging players that are making quite a bit of progress. All those companies have tricuspid programs as well.

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New kid on the block: Renal denervation

Renal denervation is a minimally invasive, FDA-approved approach using technology to lower blood pressure without medication. It works by reducing activity of renal nerves in the kidneys, which, when overactive, can increase blood pressure.

Babitt predicts renal denervation will be one of the more interesting stories in 2025, when companies sort out reimbursement and introduce approved products to treat hypertension.

“I think PFA was … a ‘GLP-1ish’ billion dollar plus opportunity for the medical technology space [in 2024]. It looks like that could be the case for renal denervation,” Babitt told MD+DI.

Big players in renal denervation include Medtronic and Recor Medical’s parent company, Otsuka.

A note about Shockwave and remote care technologies

In April, J&J announced the acquisition of Shockwave Medical, known for its intravascular lithotripsy (IVL) technology, which treats atherosclerotic cardiovascular disease with sonic pressure waves that disrupt calcified plaque.

“Johnson & Johnson’s $13.1 billion acquisition of Shockwave was not only the biggest medtech M&A move since Johnson & Johnson itself acquired Abiomed in the last quarter of 2022, but also the seventh-biggest deal from a therapeutic device manufacturer in the last decade,” according to the EY report.

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There also is a trend in cardiovascular medtech, Babitt said, for care to migrate into less acute settings.

“If that migration happens, there is going to be a lot of opportunity to really increase volumes. I know that a lot of companies are looking eagerly to facilitate and participate in that care migration [which includes wearables and at-home monitoring],” Babitt said.

Overcoming challenges into 2025

Increasing costs seem to have been more prevalent in medtech than in other industries, Babitt said.

“While we’ve seen revenue rebound at a nice clip, earnings have been and continue to be under pressure,” he said. “When we came into 2024 [in January], earnings were forecasted… to increase by about 8%, while revenue was forecasted to increase by about 5% to 6%. I would be surprised if we didn’t see that earnings growth number for 2024 closer to 5%.”

And while the number of deals done in 2024 was down from previous years, at around 100, the dollar volumes of those deals ticked up (as in the J&J Shockwave deal), Babitt said.

All in all, 2024 medtech was “reinvigorated with a lot of really promising technologies and a lot of robustness in the growth,” he said.