LoneStar Heart yesterday presented 1-year data from a follow-up study of its Algisyl hydrogel cardiac implant designed to treat patients with failing heart muscle. The presentation was made at the American Heart Association’s annual meeting in Orlando and published in the European Journal of Heart Failure.
Algisyl is a novel inert hydrogel that is designed to be directly injected into enlarged left ventricle muscle where it serves as a permanent scaffold to thicken the wall to reshape the heart to reduce muscle tension and support pumping efficiency, the Orlando, Fla.-based company said.
The study is examining the safety and efficacy of Algisyl and standard medical therapy compared to the therapy alone, with a primary efficacy endpoint of peak VO2, which measures maximal aerobic capacity, LoneStar Heart said.
The study reported patients treated with the company’s device showed mean treatment effects of 2.10 mL/kg/min at 12 months, which the company said is an improvement over 6 month data which showed a treatment effect of 1.24 mL/kg/min.
Patients treated with Algisyl reported a mean 101-meter 6-minute walk test score, and 85% of patients in the group were observed to be in the New York Heart Association functional class I or II, the company said.
“The outcomes from the Augment-HF study reported today confirm that Algisyl patients experienced significant improvements over the controls. These improvements were larger and more significant than the previously reported 6-month follow-up showing continued benefit. These results support further evaluation of this novel therapeutic approach,” Dr. Douglas Mann of the Washington University School of Medicine said in prepared remarks.
LoneStar Heart said the trial was not “statistically powered to assess mortality and morbidity,” but reported 13 deaths at 12-months, including 4 in the control group and 9 in the Algisyl group. Patients in the treatment group reported a 15% rate of worsening heart failure compared to 34.2% in the control, and a 2.5% rate of sustained ventricular arrhythmias compared to 13.2% in the control group.
LoneStar Heart won CE Mark approval in the European Union for Algisyl last year and won an investigational device exemption from the FDA to carry out a pivotal clinical study of the devie in the U.S.