The Alameda, Calif.-based company said the Cheetah trial is slated to enroll up to 400 patients with coronary thrombus who are referred for percutaneous coronary intervention.
The study’s primary endpoint is a composition of cardiovascular death, recurrent myocardial infarction, cardiogenic shock or new or worsening New York Heart Assn. Class IV heart failure at 30 days. Secondary endpoints include final TIMI flow and thrombus grade, as well as safety assessments at six months. Penumbra estimates the primary completion date as February 2022 with a study completion date set for June 2022, according to ClinicalTrials.gov.
The Indigo system is designed to remove clots from arteries and veins in the peripheral vasculature by delivering continuous vacuum suction to its aspiration catheters to treat thrombus in vessels.
The Indigo CAT RX aspiration catheters and Indigo Separator 4 are part of the Indigo aspiration system and are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
“Penumbra has adapted over 10 years of neuro thrombectomy experience to address the limitations of traditional manual aspiration for the coronaries by development of the Indigo System CAT RX device,” Manatee Memorial Hospital (Bradenton, Fla.) director of cardiac catheterization laboratory Dr. Jay Mathews said in prepared remarks. “This significant upgrade in innovation from syringe-based aspiration to mechanical power aspiration coupled with highly trackable catheter technology has enabled us to improve our door to reperfusion times and thereby to improve patient care.”
“Just like the IMS-III trial for ischemic stroke, the Total trial highlighted that new therapies are needed to improve the outcomes of these patients with high thrombus burden,” added Barnes Jewish Hospital/Washington University School of Medicine (St. Louis, Mo.) director of cardiac catheterization laboratory Dr. Jasvindar Singh. “The Cheetah study is the first step toward making coronary mechanical thrombectomy standard of care for high thrombus burden patients. We expect this study to refine our technique of thrombus aspiration and better understand the utilization of CAT RX for patients with high thrombus burden.”
Shares of PEN were up 0.9% at $143.70 per share in mid-afternoon trading today.