A novel device developed in Minnesota to dramatically improve heart-attack patients' survival rates has been approved for sale in the United States after 20 years of work.
The Food and Drug Administration on Monday announced full approval for Roseville-based Advanced Circulatory Systems' ResQCPR System, which is used by paramedics and first responders to give more effective cardiopulmonary resuscitation (CPR) on patients whose hearts stop beating.
More than 800,000 people in North America and Europe have sudden cardiac arrest outside of the hospital, and on average only about 5 percent survive the experience, according to a 2011 article by the Lancet on CPR.
Federally sponsored research on the ResQ system found that patients whose hearts stopped outside the hospital had a better chance of surviving for a year with good neurological function if they were treated with the device in the field.
All told, 8.8 percent of patients survived using the device, compared with a control group using traditional CPR that had a one-year survival rate with neurological function of 5.9 percent.
That's an improvement in survival of about 50 percent, applicable to a population of many thousands of heart-attack sufferers. Despite its lifesaving potential, the device had a four-year approval process with the FDA partly because it's a first-of-its-kind invention.
"There's never been anything like this previously," said Dr. Keith Lurie, an electrophysiologist and inventor who founded Advanced Circulatory Systems to research and commercialize devices based on the principle of intrathoracic pressure regulation (IPR).
"One of the reasons it took so long," Lurie said, "is because all of the people involved in making the decision wanted to make sure that the data were real and it was the right decision to make."
Essentially, IPR uses special devices to turn the chest into a bellows for compressions, allowing oxygenated blood to flow through the heart and to the brain while the heart is still stopped. It's similar to traditional CPR but more effective in pumping blood.
The ResQCPR system includes two parts: a suction-cup device that lets a first-responder pull up on the chest and deliver compressions more effectively and a breathing-mask attachment that regulates airflow to maximizes blood flow to the heart.
"When used together, the two devices may increase the amount of oxygenated blood circulated through a patient's body during CPR," the FDA announced Monday.
The device is expected to cost around $1,000, and its main buyers will be ambulance companies, hospitals, fire and police departments, and other professional emergency-response groups. Company CEO Mike Black said a consumer-oriented version of ResQ may someday hit the market as well.
Advanced Circulatory Systems announced in December that it was being acquired by Massachusetts-based Zoll Medical Corp., which sells emergency-care devices like external heart defibrillators. Terms of the deal between the privately held companies were not disclosed.
Zoll is owned by the Japan-based conglomerate Asahi Kasei Group, which has 29,000 employees worldwide.
Black said Monday that Advanced Circulatory will keep its offices and 15-Minnesota based employees in the state, and the company may expand its local workforce as sales of ResQ pick up.