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External Counterpulsation Therapy, Evolved

The next evolution of external counterpulsation (ECP) therapy: FDA-cleared1, data-driven, patient-centric and portable— designed for today’s cardiovascular practice and clinical environments with minimal setup and reduced staffing needs.

Clinical Evidence

FDA-Cleared Clinical Trial Results

In the WaveCRESST clinical trial, the Wave Pro System delivered equivalent diastolic augmentation and systolic unloading as the predicate ECP device using pulse-synchronized calf compression1.  ECP therapy has been shown to help reduce symptoms related to Chronic Stable Angina. The Wave PRO also evidenced a reduction in setup complexity and provides a lean staffing model that is superior to existing ECP devices while enhancing patient comfort1.

In the randomized, crossover-controlled WaveCRESST trial, Wave PRO demonstrated

Equivalent diastolic augmentation ratio
(+0.26 vs predicate; p < 0.0001)1

Proven non-inferior vs predicate ECP system1

Patients found the Pression Wave PRO more comfortable than existing ECP devices1

Wave PRO required less set up time

Wave PROTM system is designed for simplicity and efficiency

Unlike legacy ECP systems which require lengthy setup and constant staff supervision, Wave PROTM  sets up in just a few minutes and therapy is delivered using a PPG sensor to oversee the automated compression-timing algorithm for the session. The result is a streamlined, resource efficient, almost hands-free delivery experience that gives patients privacy while freeing clinical staff from continuous monitoring.

Indications for Use

  • 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 40kg. 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 professional5.

  • Available through prescription and eligible for insurance coverage5.
  • Delivered one hour daily for 35 sessions.

Ease of Integration

The Wave PROTM is a complete turnkey system with full warranty, replaceable components, and dedicated support to ensure continuous, reliable operation.

  • Setup in under five minutes1
  • Minimal staff training required
  • Portable and compact footprint fits outpatient or cardiac-rehab environments
  • Enables lean staffing models and delivers efficient capital utilization
  • Compact 34 kg system with a small footprint (24in x 24in), easily portable between treatment rooms.
  • Calf-only sleeves with five inflatable bladders that activate sequentially from ankle to knee.
  • Automated compression control using a fingertip PPG sensor and intelligent timing algorithm synchronized with the cardiac cycle.
  • IEC 60601-1, ISO 14971, and EMC compliant 1
  • Human factors tested

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FDA-Cleared Clinical Trial Results
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Footnotes:
[1] National Library of Medicine (U.S.). WAVECRESST Clinical Trial Results. ClinicalTrials.gov identifier: NCT06571370. Updated September 3, 2024. Accessed January 28, 2026. https://clinicaltrials.gov/study/NCT06571370
[2] Shah SA, Shapiro RJ, Mehta R, Snyder JA. Impact of enhanced external counterpulsation on Canadian Cardiovascular Society angina class in patients with chronic stable angina: a meta-analysis. Pharmacotherapy. 2010 Jul;30(7):639-45. https://doi.org/10.1592/phco.30.7.639.
[3] Pettersson, T., Bondesson, S., Cojocaru, D. et al. One year follow-up of patients with refractory angina pectoris treated with enhanced external counterpulsation. BMC Cardiovasc Disord 6, 28 (2006). https://doi.org/10.1186/1471-2261-6-28
[4] Wu, Eline MNSc, RN; Desta, Liyew PhD, MD; Broström, Anders PhD, RN; Mårtensson, Jan PhD, RN. Effectiveness of Enhanced External Counterpulsation Treatment on Symptom Burden, Medication Profile, Physical Capacity, Cardiac Anxiety, and Health-Related Quality of Life in Patients With Refractory Angina Pectoris. The Journal of Cardiovascular Nursing 35(4):p 375-385, 7/8 2020. | https://doi.org/10.1097/JCN.0000000000000638
[5] Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. CMS Publication 100-04. Updated periodically. https://www.cms.gov/regulations-and-guidance/guidance/manuals/internet-only-manuals-ioms-items/cms018903
[6] Zuj KA, Prince CN, Hughson RL, Peterson SD. Enhanced muscle blood flow with intermittent pneumatic compression of the lower leg during plantar flexion exercise and recovery. J Appl Physiol (1985). 2018 Feb 1;124(2):302-311. https://doi.org/10.1152/japplphysiol.00784.2017. 

IMPORTANT SAFETY INFORMATION 
Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. 

Indications for Use 
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 40kg. 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.
Contraindications 
The Pression Wave PRO is contraindicated in patients with: moderate to severe peripheral vascular disease (PVD), cardiac catheterization or arterial femoral puncture in the past 2 weeks, pacemaker or other implantable pulse generating device, valve disease, including aortic insufficiency, abdominal or thoracic aortic dissection or aortic/cerebral aneurysms requiring clinical intervention, severe pulmonary disease, bleeding diathesis, coagulopathy, pregnancy, baseline heart rate <40 BPM or >120 BPM, arrhythmia and/or abnormal heart rhythm; major hand injuries or amputation of both hands, local infection on one or both calves, severe lower extremity vaso-occlusive disease, open or freshly healed ulcers or other wounds or otherwise fragile skin from the knee to the ankles, active thrombophlebitis, uncontrolled hypertension (greater than 180/110 mmHg), stents (arterial/venous) or medical implants in the calves, unhealed wounds/fractures below the waist or lower limb amputation, any major surgery within the past 3 months (defined as highly invasive procedures requiring the removal of, or trauma to, organ tissue, an organ, or body part that requires general anesthesia and/or results in an extended hospital stay).
Warnings & Precautions
The Pression Wave PRO must be used under the supervision of a qualified healthcare professional. The PPG sensor is not intended to be used under motion or low perfusion conditions. Cotton stockinettes must be worn under the calf sleeves to prevent skin irritation and/or discomfort. The patient’s fingers should be clean and devoid of nail polish/extensions to avoid compromise of the PPG signal. Use of accessories and cable equipment other than those provided or specified by Pression could result in increased electromagnetic emissions or decreased electromagnetic immunity and can result in improper operation. Refer to the IFU (LBL016) for additional warnings and precautions.
Potential Adverse Events
Potential adverse events associated with the Wave PRO System are the same as for any ECP system, including paresthesia, edema/swelling, skin abrasions, bruises, blisters and leg/back pain.
Caution 
Federal (USA) law restricts this device to sale by or on the order of a physician.