A gentle hug of the heart. That's the simple theory – and literal application – behind a new treatment for congestive heart failure (CHF).
It looks like the stretchy mesh material used to protect expensive produce, such as Asian pears. But the super-elastic compliant nitinol structure of HeartNet envelops far more precious contents.
And not just protecting the heart, it's designed to augment function, potentially preventing CHF from advancing, by reversing the progressive enlargement.
Surgeons from Wayne State University School of Medicine (Detroit) and Oakwood Healthcare System (Dearborn, Michigan) successfully implanted HeartNet for the first time in a 49-year-old patient just two weeks ago. After a four-day hospital stay, the patient went home and now reports feeling better already.
"The utility of HeartNet is that it may add to the armamentarium of devices and therapies to delay the progression of heart failure, or even halt it, to avoid advancement to mechanical therapy or a heart transplant," Salik Jahania, MD, the cardiothoracic surgeon who performed the procedure, told Medical Device Daily. "This is a stand-alone therapy with a minimally invasive approach and a short hospital stay" the minimally invasive strategy being extra-important these days.
Jahania is co-principal investigator of the clinical research study, launched with the initial implantation.
The HeartNet was invented and is manufactured by Paracor Medical (Sunnyvale, California). Paracor plans to enroll patients at up to 30 U.S. centers under an FDA-approved investigational device exemption. Designated PEERLESS-HF (Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure), the HeartNet study will enroll 272 patients.
The American Heart Association (Dallas) and the Heart Failure Society of America (Washington) estimate that more than 5 million Americans have been diagnosed with heart failure, the leading cause of hospital admissions in the U.S. And only about half of Americans diagnosed with heart failure will survive more than five years, the disease producing 300,000 deaths every year.
While the HeartNet approach sounds highly novel, it isn't the first such strategy. Acorn Cardiovascular (New Brighton, Minnesota) has struggled to win FDA approval for its CorCap cardiac support device that puts a sort of jacket around the heart, but requiring open surgery.
An FDA panel voted in 2005 against recommending PMA approval of CorCap (MDD, June 24, 2005). But the company appealed to the FDA going to its dispute resolution panel – and last spring, finally won approval for a 50-patient confirmatory trial (MDD, May 10, 2007).
The FDA panel's main concerns centered on gaps in New York Heart Association (NYHA) functional class follow-up data and the lack of substantial evidence of efficacy, compared to the control group in the trial (MDD, June 24, 2005).
"My expectation, as Acorn undertakes 50 additional patients, is that they will be successful," Paracor's president/CEO William Mavity told MDD. "I expect them to get approved. Nobody else is doing this [besides Paracor and Acorn]. There's room for a number of other players in this field. But our procedure is simpler [than Acorn's] and the morbidity, arguably, will be less."
He said another trial, much larger than the current PEERLESS-HF study, will be needed to prove the morbidity benefit.
HeartNet is implanted through an incision in the left side of the chest, the mplantation procedure guided by an X-ray camera projecting images on an operating room screen. The tool designed to introduce the HeartNet into the chest cavity contains a number of "fingers" that spread the mesh around the heart, and then retract once the device is properly placed. The procedure can typically be completed in 90 minutes or less.
"The novelty is that it can be implanted minimally invasively," Jahania said. "It's a small incision – 7 cm over the tip of the heart. We open up small hole in pericardium, the lining around heart, and then a plastic tube is inserted in that hole. Through that hole, the crimped neck is delivered ... finger-like plastic extensions unfurl as we deliver the device around both chambers of the heart. Then we pull the handle, like a rip cord, and we withdraw the instrumentation. It's relatively easy to reach in there and adjust if needed. And it requires no suturing to stay in place."
HeartNet is a permanent implant and does not prohibit future surgeries if needed.
Robert Mentzer Jr, MD, dean of the Wayne State University School of Medicine and study co-principal investigator, is obviously excited about HeartNet's potential, saying the implant could "reduce the need for heart transplants among some patients."
The PEERLESS-HF study is targeting New York Class II-III patients, those who are moderately sick, who would eventually are likely to need mechanical assist devices and heart transplants. These patients have had heart failure for at least six months, received standard therapy and have responded to the extent that they benefited, but continue to have symptoms that put them in Class II-III.
Mavity predicts study completion and approval of HeartNet by 2010 and commercialization of the device in a range of $10,000 to $15,000 to a potential 200,000-patient population in the U.S.
With potential earnings upwards of $2 billion, Paracor is investing everything in HeartNet, its flagship and only product. Mavity said that European CE mark approval applications are already filed.
Last year, Paracor raised $44.35 million in its Series D financing (MDD, July 5, 2007). "At the pace we're moving, it's enough to get us through the trial," Mavity said. "But then we will need to raise more money if we have regulatory approval."