The surgical version of Algisyl® has been evaluated in two clinical studies including AUGMENT-HF, a controlled, randomized trial whose patients were treated in 14 centers in Europe and Australia. The 12-month outcomes were presented widely and published in 2016 (Eur J Heart Fail. 2016 Mar; 18(3):314-25). The primary endpoint of AUGMENT-HF is peak VO2, an objective measure of maximal aerobic capacity that is considered the best indicator of cardiovascular health as it correlates strongly with clinical symptoms, morbidity, and mortality. Patients treated with Algisyl® had an average increase of 2.10 mL/kg/min vs controls reaching a mean peak VO2 of 14.0 (±3.1) mL/min/kg. This result represents a sizeable and continuous improvement that compares favorably with efficacy trial outcomes for CRT-D, the most successful HF devices introduced in the last decade for a specific patient segment. The peak VO2 outcomes also correlated consistently with other efficacy endpoints such as the 6-minute-walk test, quality of life measurements, NYHA classification, and heart failure re-hospitalization.
The AUGMENT-HF trial data broadly corresponds with the results of a previous first-in-man study that was carried out at two centers in Germany and was concluded after a two-year follow-up in December 2012. Results were published in the International Journal of Cardiology (Int J Cardiol. 2013 Oct 3; 168(3):2022-8). In that study, Algisyl-LVR was administered in a concomitant procedure for individuals with HF and dilated cardiomyopathy who also required a bypass graft or valve repair. The study showed excellent safety, feasibility, and clinical outcomes.
The strong clinical outcomes of Algisyl® injected surgically led to an approval to market in Europe (CE-Mark). The clinical data also contributed to the approval by the US FDA of an Investigational Device Exemption (IDE) as well as a trial design for Post-Market Approval (PMA). For more details, visit the ClinicalTrials.gov website at the National Institutes of Health (NIH) (www.clinicaltrials.gov) and search for the term Algisyl.
CAUTION: Investigational device. Limited by United States law to investigational use only.