Pulmonary Vein Isolation (PVI) procedure

The most successful treatment for atrial fibrillation, called pulmonary vein isolation (PVI) ablation, is performed to stop unwanted electrical impulses from entering the atria, a significant cause of this heart condition.

The primary unmet clinical need is to eliminate the approximately 1/3 of PVI procedures that lead to recurrence and repeat procedures.

Recurrence occurs most often due to pulmonary vein (PV) reconnection, allowing impulses to enter the atria, and is often caused by:

  • Inconsistent catheter-to-tissue contact leaving gaps in ablated lesions.
  • Focal-point ablation requires filling–in overlapping points to avoid leaving gaps.
  • Inconsistent catheter-to-tissue contact leads to varying energy dosage at contact locations:
    • too small a dosage yields non-transmural lesions.
    • too large a dosage may cause injury to surrounding tissue.

Clinician Preferences to improve PVI

  • Single-Shot device
  • Simplify procedure methods
  • Minimize procedure time
  • Enhance pulmonary vein isolation durability

Market

  • 33.5M AF patients diagnosed globally
  • WW AF Ablation market is $1.7B (CAGR 12-15%)
  • 500,000 AF (est.) catheter ablations per yr. WW
  • 15% of strokes are caused by AFib
  • ‘Single-shot’ devices outpacing market growth by up to 5%
  • Only 3% market penetration
  • Highly competitive M&A landscape – $331M median acquisition price
Scroll