is supposed to restore the geometry, function, and ordinary volume of blood that is required of a healthy heart. If something goes wrong, it can be tricky, however. The device is made to anchor in the heart permanently, and when the Parachute has been removed, it has typically been done surgically, Templin says. Once in early development, the parachute didn’t deploy properly and it was pulled back out, he says.
While many patients with heart failure just develop an enlarged heart as they age, leading to severe weakness and fatigue, the CardioKinetix device is specifically designed for patients who have suffered a heart attack, or what’s known as an ischemic event, that damages the heart muscle. Specifically, the company looks to treat patients with a dysfunctional apex, Templin says, which either doesn’t move when the heart pumps, or moves out instead of in, when physicians look at it via an echocardiogram. Those are the patients who were eligible to enroll in the study being discussed in Paris today.
The study showed that after patients got the CardioKinetix device, they essentially improved their heart failure status from moderate to mild, on a common score known as the New York Heart Association classification. The volume of the heart’s left ventricle stayed the same after two years, researchers said. There weren’t any significant complications related to the device itself, Templin says, but the most notable complication was from the puncture site in the femoral artery where the catheter goes in. The device essentially makes a larger hole than the catheters that deliver stents, he says.
Maria Sainz, who previously led Mountain View, CA-based Concentric Medical until it was sold last year for $135 million to Stryker (NYSE: [[ticker:SYK]]) joined CardioKinetix just this past month as it gears up for today’s data release and the interesting clinical and commercial steps to come. The company has a couple of ongoing studies in Europe, and expects to have some more data to share at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October in Miami.
But the bigger next step will be a 500-patient study in which patients will be randomly assigned to get the CardioKinetix implant, or best available medical therapy. That trial will ask the same question that was asked in this study—whether the new device can lower the rate of death and hospitalization. The study, Sainz says, will be statistically designed to generate a result when 208 “events”—deaths or hospitalizations—have occurred. Since the plan is to start the trial in early 2013, and it will take time to enroll patients and follow them over time for events, it will probably take three years to get a full dataset that it can package into a formal application for FDA approval, Sainz says.
“We’ve had a lot of discussions with the FDA, and are in alignment with FDA on large majority of parameters,” she says.
Other companies have tried before to treat heart failure with an implantable device, such as Acorn Cardiovascular, to create a “jacket” for the heart to restore healthy shape and volume. But CardioKinetix says it believes it is the only company working on a heart failure device that can be inserted through a minimally invasive procedure in the catheterization lab. That’s an important distinction, Sainz says, for the device’s commercial prospects. That’s because this device makes it possible for specialized doctors (interventional cardiologists) to continue treating heart failure patients they already see, rather than being forced to refer them to another physician, like a surgeon.
Since heart failure is a chronic condition, today’s results are important. Doctors often have questions about how much benefit a device provides over the long term, which is often a hard question for startups to answer. Now that CardioKinetix has some answers, it’s off to the races to deliver FDA-caliber proof. “We’ve been pleasantly surprised with how long the results have maintained themselves,” Templin says.
