Inadequate femoral artery access causes 100,000 people to not address symptomatic aortic stenosis which is common and lethal. Without treatment, the average survival is only 2-3 years.
The TCD is an investigational closure device for transcaval access to the abdominal aorta that addresses the need for effective interventions for symptomatic aortic stenosis. We have successfully completed first-in-human, IDE EFS clinical trial for 12 patients. Transcaval access holds great promise for treating those patients who lack an access route due to insufficient femoral arterial lumen sizes to undergo TAVR and allow placement of the ≥ 18Fr sheath size required for valve delivery.