Structural Heart / TAVR

Smarter patient care,
beat by beat

Real-time sensing and pacing capabilities
via a battery-free, leadless add-on
for any commercially approved transcatheter aortic valve replacement (TAVR) device.

Device imagery is illustrative and for representational purposes only. Investigational device only. Not available for use.

Market / Structural Heart

TAVR is the dominant segment in the structural heart market.

Market size
~$7B
Market size @2026, growing every year.
Annual volume
~300K
TAVR procedures annually by 2026.
~500K by 2030.
CAGR
~8%
With market growth, complications demand greater vigilance.
The Problem / Conduction Disturbances

But, Post-TAVR Conduction Risk: A Persistent Clinical and Economic Burden

Post-procedural conduction disturbance continues to drive permanent pacemaker implantations (PPI), prolonged cardiac monitoring, and increased hospital length of stay (LOS).

TVT Registry Analysis - new PPI post-TAVR across device technologies (2014-2020)
30-day pacemaker rate after TAVR across all U.S. registry procedures.
Balloon-Expandable · n=144,042Trend p <.001
SAPIEN balloon-expandable valve
SAPIEN
Self-Expandable · n=52,965Trend p <.001
CoreValve Evolut self-expanding valve
CoreValve / Evolut
MyVal (Meril)
~15% PPI · Landmark study
Navitor (Abbott)
~19% PPI · NG study
JenaValve
~24% · Align-AR study
Allegra (Biosensors)
~16.6% · GARY

Chau et al. · TVT 2021 · Landmark data: PPI 17% (SAPIEN) and 16.8% (Evolut) at 30d · JenaValve: 14% in the last 60 pts post-30d

The problem is magnified by 3 major issues:

Issue 01

Hard to predict

New-onset conduction problems after TAVR remain difficult to anticipate at the time of the procedure.

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Issue 02

A permanent solution for a temporary problem

A lifelong pacemaker is implanted for what is often a transient disturbance that resolves within 30 days.

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Issue 03

Worse long-term outcomes

Post-TAVR permanent pacing is associated with higher long-term mortality and added downstream risk.

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Introducing / SmartValves

Meaningful patient impact.

See how SmartValves™ can transform TAVR patient management and improve the patient experience.

Device imagery is illustrative and for representational purposes only. Investigational device only. Not available for use.

The System / Sensing + Pacing

1  Integrated System
2  Active Capabilities
3  Core Building Blocks

Real-time, on-demand sensing and pacing: adding brains to passive implants through novel design, smart hardware and proprietary algorithms.

How the system works together

System architecture · Real-time, on-demand sensing and pacing
Implant +

Sensing and pacing add-on

  • Battery free and leadless
  • Assembled with commercially approved valves as part of the existing manufacturing process
Stimulation & Electrogram (EGM) telemetry
RF communication
Wearable Device

Wearable unit

  • Transmits energy to the implant
  • Communication link between the implant and the physician
Patient-specific clinical data
Settings
Physician's Control Unit

Monitoring platform

Hospital-based platform for continuous patient monitoring and management.

Images are for illustration purposes only

Care Pathway / Today vs SmartValves

From “Wait and Watch” to Safe, Systematic Next-Day Discharge

Today's standard of care extends hospital stays and too often ends in an unnecessary permanent pacemaker. SmartValves provides 30-day protection so permanent decisions are guided by patient-specific evidence.

Current Standard of Care
Increased hospital LOS - many ending in unnecessary PPI
TAVR Procedure

Valve replaced.

24-96h Hospital Monitoring

Increased costs, increased risks, clinical uncertainty.

↑40% prolonged LOS↑20% temporary pacing
Patient Discharged

Many severe on-set conditions occur. Too many return with conduction disturbances.

≥10% Receive a Permanent Pacemaker

Data shows that many of them will be pacing independent after 30 days.

Patient management with SmartValves™
Safe next-day discharge (NDD) - PPI only for those in need
TAVR Procedure

Valve replaced.

≤24h Patient Discharged

Safe NDD with 30-day protection from conduction disturbances - freeing hospital resources, enabling efficient utilization.

Therapeutic Period

Continuous EGM sensing with on-demand pacing support enables collection of patient-specific data.

Unnecessary PPI Eliminated

PPI decisions are made on the patient-specific condition at 30 days.

The Potential for Enhanced TAVR Outcomes

✓
Safe next-day dischargePatients go home faster.
✓
Better permanent decisionsFewer unnecessary PPIs, guided by patient-specific data.
✓
Fewer complicationsReduced exposure to lifelong pacemaker therapy.
✓
Substantial cost savingsLower cost to hospitals, insurers and the system.
Patient experience
Home the next day,
protected for thirty.
A healthy older patient at home
A driver's hands on the wheel with an airbag deployment visualization - SmartValves stays in the background, ready the moment it matters

Like an airbag in a car:
SmartValves™ stays in the background - ready when needed.

Once clinical benefit is established, SmartValves™ will become an essential, easily adopted addition to the standard of care. Seamlessly compatible with commercial devices, adding new capabilities for clinicians. Improving patients’ experience and safety.

Persistent Problem. Smarter Solution.

One procedure. Better outcomes for patients, clinicians, and the healthcare ecosystem.
Let’s connect and join forces on our journey to transform the TAVR space.

Contact us