Eight Forces Reshaping Cardiovascular Devices in 2026

The defining feature of PFA in 2026 is that the category question is settled and the share question is wide open.

Medtronic's disclosed numbers show what winning looks like: Cardiac Ablation Solutions revenue increased 71%, including 128% in the U.S., on strength of pulsed field ablation (PFA) portfolio, with PFA now 75% of cardiac ablation revenue.

Boston Scientific remains the scale leader but is ceding ground. Its own 10-K identifies PFA as the central growth engine: In 2025 and 2024, reported net sales growth was primarily driven by the growth of our Electrophysiology business unit, led by our Farapulse Pulsed Field Ablation (PFA) System. The segment delivered FY 2025 +74.6% in electrophysiology. Yet by April, Mahoney maintained that the company is confident it will retain its leadership position in PFA despite losing more market share than anticipated.

The field has also widened. In December, Abbott announced U.S. Food and Drug Administration (FDA) approval for its Volt PFA System, bringing Abbott's first pulsed field ablation (PFA) offering to patients in the United States.

Edwards has built its equity story on the distinction between a mature aortic franchise and an emerging mitral/tricuspid one and the company's investor conference makes the strategy explicit.

The conference framed the opportunity around the more than 20 million structural heart patients worldwide and around patient groups currently unaddressed today, such as those with asymptomatic AS and those with mitral, tricuspid or aortic regurgitation in need of a transcatheter replacement.

The Q2 2026 numbers show the two speeds cleanly: TAVR bookings climbing 10.5% to USD 1.3 billion and Transcatheter Mitral and Tricuspid Therapies (TMTT) soaring 44.8%. Management's own long-run framing confirms the split for the long-term guidance for TAVR remains mid to high single-digit growth, while Zovighian said the portfolio supports Edwards' target of reaching USD 2 billion in TMTT revenue in 2030.

Abbott is pulling the same level from a different starting point. Its filings attribute structural heart momentum to newer indications: In Structural Heart, the 13.2 percent increase in sales, excluding the effect of foreign exchange, primarily reflects growth in TriClip and Navitor products.

This is the trend most likely to be mis-modelled, because the gating constraint was removed recently enough that many forecasts still treat it as open.

It is not. The Centers for Medicare & Medicaid Services (CMS) has issued a positive national coverage determination (NCD) for renal denervation for uncontrolled hypertension, including the Symplicity blood pressure procedure, with the final decision memo. Published October 28, 2025.

Medtronic's 10-K had already flagged this as the decisive variable for the franchise:

The post-NCD volume response is the number to watch Management noted that average weekly procedures doubled after the NCD, and “early volume data suggest an annualized revenue run rate near USD 100 million”. The company estimates roughly 18 million people in the United States live with uncontrolled hypertension despite multiple medications. While 18M Americans have uncontrolled hypertension, the initial RDN addressable pool is constrained to those meeting CMS coverage criteria (optimized medical therapy), estimated at 2 to 4 million in the early ramp phase.

Clinical durability underpins the case: Long-term data in more than 2,000 patients showed sustained mean systolic BP reductions of 13.3 millimeters of mercury in ambulatory settings and 18.1 millimeters of mercury in office settings in three years.

With first-mover advantage in PFA proving perishable, the disclosed pipelines tell you where 2027-28 share will settle.

Medtronic is extending Affera into the single-shot segment: With our pipeline, we're bringing Affera technology to the single shot segment with Sphere 360. EPs tell us that 360 is the most anticipated PFA catheter out there, given the strength of its early clinical data. The company has submitted an application for an investigational device exemption (IDE) with the FDA so that it can get approval to start Sphere-360's U.S. pivotal trial.

Boston Scientific is answering with three platforms

Abbott is competing on energy-modality flexibility rather than pure PFA: In January, Abbott announced the company obtained CE Mark for its TactiFlex Duo Ablation Catheter, Sensor Enabled, designed to deliver radiofrequency (RF) and PFA energy to treat patients battling atrial fibrillation.

Cardiovascular leaders are discontinuing subscale and legacy lines rather than harvesting them and are reorganizing around the franchises that remain.

Boston Scientific's 10-K records both moves. On structure:

On exits, the filing confirms that in the second quarter of 2025, we announced the discontinuation of worldwide sales of the ACURATE Neo2 and ACURATE Prime lines that had prior year global sales of approximately USD 50 million per quarter. Cryoablation followed, with management citing some recent safety events and the availability of non-thermal ablation technologies.

The substitution effect is visible inside Medtronic too: Cryo revenue -- 40% decline, with 90% of remaining cryo revenue generated outside of the U.S.

The current deal cycle avoids horizontal consolidation in core cardiology where share positions and antitrust make it difficult in favor of adjacent pools.

Boston Scientific's 10-K sets out the cadence: In 2025, the company completed acquisitions of Bolt Medical, SoniVie Ltd., Cortex, Inc., Intera Oncology, Inc., and Anrei Medical (HZ) Co., Ltd. and a definitive agreement to acquire Penumbra, Inc., expected to close in 2026, to strengthen its Cardiovascular division.

Abbott moved outside devices entirely: We will gain leadership in the fast-growing cancer diagnostics market with the planned acquisition of Exact Sciences, which we continue to expect to close in the second quarter of 2026.

Medtronic is reshaping in the other direction, with diabetes deconsolidating in 2027 alongside stated appetite for tuck-in M&A

And the most consequential signal came from outside the cardiovascular incumbents. J&J is reallocating toward this space precisely because of the growth differential:

A point that rarely survives in market models: PFA growth costs margin in the ramp phase.

Medtronic quantified it. Operational gross margin improvement was offset by business mix, which represented a headwind of 80 basis points split roughly equally between cardiac ablation and diabetes. Management guided to more of the same continued negative gross margin mix from capital/consumables shift in cardiac ablation and early-stage diabetes ramp but expects improvement as products scale.

Four major players, four different 2026 trajectories and in every case the company number conceals a wide internal spread.

Boston Scientific's guide-down is the instructive case, because the underlying business was not weak Cardiovascular: 18.2 percent reported, 16.5 percent operational and 16.1 percent organic in Q4 2025. The reset came from three specific franchises.

• Demand-side expansion is real and reimbursement enabled. PFA, TMTT and RDN each have a coverage pathway and a documented volume response. This is not a speculative pipeline story.
• Competitive intensity is rising, not consolidating. Four credible PFA competitors, a synchronized 2027 product cycle, and capital entering from adjacent medtech segments all point the same way.
• Growth quality is uneven. The franchises driving top-line acceleration are the ones diluting gross margin in the near term, and headline company guidance obscures a very wide internal spread.