The aim of OUTLIVE is to bring the Valvosoft device on the market and to provide AS patients with a safe and efficient therapy. In order to reach this goal, Cardiawave manufactured two additional Valvosoft devices, identified important suppliers and secured agreements with the one providing critical parts of the device, finished the pilot phase of the clinical investigation and refined its go-to-market strategy.
Cardiawave completed its first international trial in ten patients. The post-procedural echocardiographic results were presented at seven international conferences.
The pilot phase was conducted as part of an international multicenter study which enrolled ten patients. These patients were not eligible for TAVI nor for open-heart surgery, mainly due to the presence of concomitant diseases or due to difficulties in accessing the blood vessels with a catheter. Therefore, they were left with no alternative treatment.
Analysis of the post-operative echocardiographic data, performed by an independent centralized laboratory, and of the clinical results at 30 days, confirms that the primary objectives, which were to assess safety and feasibility of this procedure, have been met. No adverse events related to the Valvosoft device or procedure were reported and results have also shown that none of the patients encountered neurological issues. Based on the echocardiographic results from the day after the procedure, an improvement in the hemodynamic parameters of some patients has been noted along with an NYHA class improvement observed for the majority of the ten patients.
Based on the careful review of these results and discussions with external KOLs and the Scientific Advisory Board, Cardiawave decided to extend the pilot phase of the clinical trial by enrolling ten additional patients in a new clinical investigation site in Serbia. This safety study, including MRI data acquisition aiming at ruling out risks of stroke, is currently ongoing.
During the second part of the OUTLIVE project, an extension of the first-in-man clinical study will be performed in three to four clinical centers. The pivotal study will follow in 2021 throughout Europe. A new improved Valvosoft device will also be released to improve the safety, the performance, the usability and the maintenance of the device. The collection of data on safety and efficacy of the Valvosoft device in the treatment of AS will be compiled to obtain CE-mark. In the meantime, Cardiawave will be establishing close contact with users and payers to ensure swift and successful market access following CE-marking now expected at the end of 2022 or beginning of 2023.
