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CLINICAL DATA

CLINICAL DATA

Effectiveness Clinically Approved

The latest study which included 25 patients with severe pulmonary valve regurgitation (in the native RVOT) showed 100% success rate and good mid-term effectiveness without device-related serious adverse events.

CLINICAL DATA

Pressure before and after PULSTA™ Implantation

Pressure between the RV and the PA before and after PULSTA™ implantation shows that even after 4 years of implantation, the PULSTA™ is safe and stable in its performance.

CLINICAL DATA

The NYHA functional class before and after
PULSTA™ implantation.

NYHA functional class of patients improved to class I in
all patients after PULSTA™ implantation.

The New York Heart Association (NYHA) functional class

  • Class 1
    No limitations. Ordinary physical activity does not cause under fatigue, dyspnea, or palpitations.
  • Class 2
    Ordinary physical activity causes fatigue, dyspnea, palpitations, or angina.
  • Class 3
    Comfortable at rest; less than ordinary physical activity causes fatigue, dyspnea, palpitations, or angina.
  • Class 4
    Symptoms occur at rest; any physical activity increases discomfort.