CardioKinetix has spent 10 years and $80 million in venture capital working on an implantable device for people with heart failure. Now it’s got some evidence that suggests it could be on track with a real product.
The Menlo Park, CA-based company is announcing today it has passed a study of 31 patients who got an implantable device designed to help the heart beat more efficiently after the muscle is damaged by a heart attack. About 16 percent of the patients died or had to be hospitalized within one year of getting the heart failure implant, and 32.3 percent suffered that fate within two years.
The trial lacked a control group, so it’s impossible to directly compare how those patients would have done otherwise. But historic studies have shown that about 40 percent of patients can expect to die or be hospitalized after one year, and about 60-65 percent would normally end up that way on standard treatments, according to CardioKinetix’s executive director of therapy development, Barry Templin.
The findings, being presented today at the EuroPCR meeting in Paris, mean that CardioKinetix is now in position to see if its product can really pass muster in a more rigorous study of 500 heart failure patients in the U.S.—the kind of evidence it will need to win FDA approval. The CardioKinetix device isn’t intended to help all of the 2.5 million people worldwide diagnosed annually with different types of heart failure, but it could end up being a new option for about 20-30 percent of patients with a form of this chronic disease, Templin says.
“Our device isn’t just a quick fix, we’re seeing long term benefit,” Templin says. One of the study’s investigators, Marco Costa of the Interventional Cardiovascular Center at Case Western Reserve University, gushed in a company statement saying, “it is difficult to contain our enthusiasm because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population. The sustained and concordant improvements in symptoms, heart function, and clinical outcomes are compelling, with a very acceptable safety profile.”
Before diving in too deep into the details of this study, a little background is required on what CardioKinetix is attempting to do. The private company got its start in 2002, and has raised its cash from a well-known syndicate that includes SV Life Sciences, New Leaf Venture Partners, U.S. Venture Partners, Panorama Capital, and H&Q Healthcare Investors. CardioKinetix has about 30 employees today, Templin says.
The big idea at CardioKinetix is to develop what it calls its Parachute Ventricular Partitioning Device. The way this works, a technician slides a narrow catheter into a patient’s femoral artery in the leg, threads it into the heart with the Parachute device tightly bound to the catheter. Once inside the heart’s left ventricle, the device gets popped open like a parachute, and it has tiny hooks on the edge that enable to to anchor itself in position in the heart muscle. The procedure is supposed to take 40-60 minutes.
Once the implant is in place, physicians hope to essentially wall off part of the heart muscle that gets loose and damaged after a heart attack, which makes it harder for the heart to pump blood in and out efficiently. Walling off part of the heart 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: 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.
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