|The ResQCPR System--Courtesy of the FDA|
The U.S. Food and Drug Administration has approved the ResQCPR System to perform cardiopulmonary resuscitation (CPR) on cardiac arrest patients. The CPR system is from startup Advanced Circulatory Systems, which was acquired for an undisclosed amount by Zoll Medical in January. The deal was first announced in December after a May 2014 FDA panel recommended the system's approval.
The ResQCPR System is intended to improve patient chances of surviving a cardiac arrest, which happens to about 300,000 U.S. patients outside of the hospital annually. The idea is to increase the amount of oxygenated blood circulating through a patient's body during CPR. The system will be available commercially in mid-2015.
It's expected to improve upon manual CPR and consists of two devices: the ResQPump Active Compression Decompression CPR Device, which has a handle that attaches to the patient's chest with a suction cup and has pressure gauge to assess compression depth and timing, and the ResQPod 16.0 Impedance Threshold Device, which fits onto a rescue face mask or breathing tube. The latter impedes airflow during chest compression in order to reduce chest compression and bring blood back to the heart.
"Most people who suffer cardiac arrest outside of a hospital die," said Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in a statement. "The ResQCPR System may increase oxygenated blood circulation during CPR, which in turn may improve the likelihood of survival in adult patients with out-of-hospital, non-traumatic cardiac arrest."
The data presented to the FDA on the system included randomized study with 813 subjects that received standard CPR versus 842 subjects who received CPR with the ResQCPR System. The study found that those patient treated with the ResQCPR System had a 52% greater chance of leaving the hospital with favorable neurological function and a 49% increase in one-year survival with near-normal or normal brain function.
"This is the most significant advance in the field of cardiac arrest since defibrillation. The ResQCPR System profoundly increased blood flow to the heart and especially the brain in pre-clinical studies," the lead investigator for the ResQTRIAL, Dr. Tom Aufderheide, said in a statement. "The ResQTRIAL showed it could save thousands of lives each year in the United States and, in my opinion, should become a new standard of care."
Advanced Circulatory Systems will continue to operate out of Minnesota and will be part of Zoll's Core Products division. Zoll is an Asahi Kasei Group company.
"The acquisition of Advanced Circulatory Systems will broaden Zoll's product offerings with additional technologies designed to improve outcomes from cardiac arrest and other critical conditions," said Jonathan Rennert, President of Zoll, said in a December statement. "This acquisition further demonstrates Zoll's commitment to offering the most comprehensive portfolio of products for acute events where rapid medical intervention is needed."
- here are the FDA and the Zoll releases