|CardiacAssist got FDA approval for a pivotal trial for TandemHeart--courtesy of CardiacAssist|
HeartWare ($HTWR) and Abiomed ($ABMD) roam the upper reaches of the heart pump market, but privately held CardiacAssist is angling to get its TandemHeart FDA-approved, now securing the agency's blessing for a pivotal trial.
The device uses left atrial cannulation to bypass the left ventricle in damaged hearts, aiding cardiac function after a heart attack, and the pivotal trial will test TandemHeart's ability to reduce the infarct size for patients who have suffered a severe attack.
The primary endpoint is an improvement in myocardial salvaging, but CardiacAssist will also keep tabs on the device's economic impact, as it could cut down rates of rates of repeat hospitalization and ICD implantation.
CardiacAssist will start the trial early next year, starting with about 20 hospitals around the country. The company didn't disclose how many patients it will enroll, and CardiacAssist didn't return a call for comment Wednesday morning.
Getting the FDA's OK for the trial is a major milestone for the company, CEO John Marous said, and now it's up to CardiacAssist to demonstrate TandemHeart's value to patients.
"With the completion of our pre-clinical animal studies, which showed a strong correlation between high degrees of ventricular unloading and improved myocardial salvage, we are excited to extend this concept to human trials and hopefully achieve similar clinical benefits," Marous said in a statement.
- read CardiacAssist's statement