Pression, Inc., a medical technology innovator specializing in noninvasive circulatory health, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Wave PRO™ External Counter-Pulsation (ECP) System. This milestone clearance allows Pression to commercially market its patented, cardiac-gated compression technology for the treatment of patients with chronic stable angina (CSA). By synchronizing external pressure with the patient’s heart rhythm, the Wave PRO offers a smart, portable solution designed to enhance blood flow and improve quality of life for those suffering from debilitating cardiovascular symptoms.
With this milestone, Pression moves into commercial manufacturing, distribution, and engagement with healthcare providers in outpatient and cardiac rehabilitation settings.
"Receiving FDA 510(k) clearance for the Pression Wave PRO is a definitive turning point for our company and, more importantly, for the millions of patients living with chronic stable angina," said Adam Salamon, CEO of Pression. "This technology began as a way to enhance performance in the military, and today, it is a cleared medical solution that brings the benefits of cardiac-gated compression out of the clinic and directly to outpatient care. Our mission has always been to make life-enhancing circulation therapy accessible, comfortable, and smart. With this clearance, we are ready to begin the next chapter of cardiovascular care in the United States.”
About the Wave PRO™ External Counter-Pulsation System
External counterpulsation (ECP) as a general technology involves the application of pressure to the patient’s legs using inflatable cuffs or sleeves to enhance perfusion at the heart. ECP using the Wave PRO involves wrapping the patient’s calves in sleeves containing inflatable bladders, which compress the calves in sync with the patient’s cardiac cycle. During diastole, a series of five bladders within the sleeves inflate sequentially from the patient’s ankles towards their knees. This compression results in diastolic augmentation, which is observable from the pulse data obtained using a fingertip photoplethysmography (PPG) sensor. During the diastolic phase, the heart is relaxed, allowing for coronary perfusion to the cardiac muscle. By compressing the inflatable bladders during this portion of the cardiac cycle, aortic retrograde flow is increased, allowing for enhanced coronary perfusion.
The Pression Wave PRO External Counter-Pulsation System is indicated for the treatment of chronic stable angina (CSA) that is refractory to optimal anti-anginal medical therapy and without options for revascularization in adult patients that weigh greater than 40 kg. In addition, it is intended for use in healthy adult patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the supervision of a healthcare professional.
About Pression
Headquartered in Coatesville, Pennsylvania, Pression, Inc. is a pioneer in noninvasive circulatory health. Founded in 2016 by former Lockheed Martin deputy corporate chief scientist and a team of medical entrepreneurs, the company specializes in smart, cardiac-gated compression technology. Pression’s flagship product, the Wave PRO, utilizes patented algorithms to synchronize external compression with a patient’s unique heart rhythm, enhancing blood flow and reducing the debilitating symptoms of chronic stable angina.
Pression is committed to providing quiet, portable, and affordable solutions that bridge the gap between clinical therapy and daily life. The company plans to work with clinical partners to support adoption of Wave PRO across outpatient settings. For more information, visit pression.com.
Media Contact
Alain Van Loo
COO, Pression
alain@pression.com
