ALGISYL – a novel option for heart failure patients…

Algisyl® is a gel that is derived from one of nature’s most basic structures, a family of polymers that are essential building blocks in marine algae. The raw materials are purified extensively to the point of being contaminant-free and inert such that the human immune system does not recognize them as foreign. While generic alginates are used widely for wound healing, dental applications, drug formulations, and food additives, the Algisyl® formulation is patented worldwide and produced exclusively to a purity level that is suitable for tissue engineering purposes.

Algisyl® is injected directly into the heart muscle of patients who have a condition known as chronic or advanced Heart Failure with reduced Ejection Fraction. In most of these individuals, the disorder is characterized by an abnormal enlargement of the left ventricle, thinning of the muscle wall, increased stress and uneven wall tension, and inefficient oxygen consumption. The heart progressively loses blood pumping capacity leading to severe physical limitations, discomfort, and repeated decompensation events that require hospitalization.

Depending on the size of the enlarged heart, approximately 10-20 large drops of Algisyl® hydrogel are injected directly into a specific area of the left ventricle muscle. As it sets, the hydrogel thickens the ventricle wall and re-orientates the inner muscle cells shrinking the ventricle diameter, improving muscle stretch, and reducing wall tension. The hydrogel does not degrade but remains in the muscle as a permanent implant where it is well-tolerated. The immediate reshaping effects lead to sustained improvements in cardiac function and clinical symptoms for most patients. While efforts to reshape the dilated ventricle have been attempted in the past, the mechanism of Algisyl® as an intramuscular implant is novel and unique. The treatment only requires a single procedure that does not conflict with drug management or other devices such as pacemakers or implanted defibrillators.

Algisyl® has been evaluated in 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 peer-reviewed cardiology journals. The sizeable improvement in peak VO2 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 clinical trials for safety and efficacy of Algisyl® were initially generated with a surgical approach that required open chest surgery and full anesthesia. At present, an alternative, minimally invasive method of delivery is being developed without modifying Algisyl®. With it, interventional cardiologists can access the heart muscle from a small opening in the groin by inserting the MyoTEC™ System and navigating through arteries to the interior of the heart’s left ventricle. This percutaneous approach is expected to eliminate the disadvantages of open chest surgery and increase the number of eligible patients.

CAUTION: Investigational device. Limited by United States law to investigational use only.