As quoted in the press release:
To date, 34 patients have been treated with the Tiara valve at ten different medical centers across the United States, Canada, Germany, Italy, Belgium, Switzerland and Israel. The technical success rate in these implantations is 31/34 or 91.1%. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases. All cause, 30-day mortality in the 33 patients who have reached 30 days post implant with TiaraTM is 12.1% (4/33). The remaining patient treated within the last 30 days is recovering well. To date, the longest surviving patient has passed 3.5 years post implant.
“Transcatheter implantation of the Tiara mitral valve resulted in immediate elimination of MR and improved the performance of the heart, without the need for any cardiac support device and with no procedural complications,” commented Professor Dr. Ulrich Schafer, an Interventional Cardiologist from the Cardiology Department at the University Heart Center Hamburg and one of the CE Mark trial’s principal investigators.