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Frequently Asked Questions – Healthcare Professionals

Renew™ ECP Therapy is a non-invasive and non-surgical therapy process that uses a medical device to deliver External Counterpulsation (ECP). ECP enhances blood flow through timed inflation of pressure cuffs wrapped around the calves, thighs and hips. The inflation of pressure cuffs occurs in between each heartbeat, compressing the blood vessels and pumping blood back to the heart and throughout the body.

This enhanced blood flow brings about a multitude of health benefits.

Three sets of inflatable cuffs, much like ordinary blood pressure cuffs, are wrapped around the calves, thighs and hips. ECG electrodes applied to the chest enable the Renew™ NCP-5 system to time cuffs inflation precisely to the rhythm of your heartbeat. When the heart is at rest, the cuffs are inflated sequentially from the calves to the hips. This compresses the blood vessels, thus enhancing circulation of blood flow back to the heart. Prior to the next heartbeat, all three cuffs deflate simultaneously. The rapid deflation of the cuffs significantly reduces the amount of work required of the heart to pump oxygenated blood to the rest of the body.

The earliest ECP devices inflated all the cuffs simultaneously. To better “milk” blood from the legs, more recent devices inflate the cuffs in a sequential manner: first the calves, then the thighs, then the hips. This improved version of ECP is often called “enhanced ECP”. Since all modern ECP machines use some variant of the “enhanced” method, the terms ECP and enhanced ECP are sometimes used interchangeably. Renew™ NCP-5 uses the enhanced ECP technology.

ECP therapy enhances blood flow to all parts of the body, including organs such as the brain, heart, kidneys, liver and skin. This improves delivery of oxygen and nutrients and removal of carbon dioxide and waste product. The hemodynamic effects from ECP therapy leads to improved endothelial functions and stimulates release of nitric oxide. Clinical evidences indicated that ECP promotes vascular health (fitness of the arteries) and reduces inflammation1.

Renew™ ECP Therapy is indicated for treatment of chronic stable angina. Renew™ NCP-5 is cleared by the U.S. FDA and Singapore HSA. Many clinical studies have proven ECP to be effective in reducing angina symptoms and improving exercise capacity in patients with angina pectoris2.

Besides chronic stable angina, many clinical studies on ECP have also been done and have shown beneficial effects for the following conditions:

  • congestive heart failure3, 4
  • diabetes5, 6
  • high blood pressure7, 8, 9
  • ischemic stroke10, 11
  • renal diseases12, 13
  • erectile dysfunction14, 15

Please refer to the references for some of these clinical studies.

As with most medical-related procedures, results may vary from patient to patient.

Renew™ NCP-5 ECP device is indicated for the treatment of chronic stable angina. However, with enhanced blood circulation, ECP therapy also improves many other symptoms associated with poor blood circulation, such as, fatigue, weakness, shortness of breath, dizziness, numbness, and swelling.

Many clinical studies have shown ECP to have beneficial effects for the following conditions:

  • congestive heart failure3, 4
  • diabetes5, 6
  • high blood pressure7, 8, 9
  • ischemic stroke10, 11
  • renal diseases12, 13
  • erectile dysfunction14, 15

Please refer to the references for some of these clinical studies.

Prior to starting Renew™ ECP Therapy sessions, patients are recommended to undergo an ECG test. If your patients have any of the conditions listed in the Contraindications, they should not undergo Renew™ ECP Therapy.

It feels like a firm massage with pressure applied to the hips and legs at regular intervals. The intensity of the pressure is adjustable to ensure a comfortable and effective treatment.

Renew™ ECP Therapy is an external procedure that is non-surgical and virtually risk-free. It does not require hospitalisation or the use of drugs. Clinical studies have shown that results for ECP therapy are comparable to that of traditional treatment methods such as angioplasty and bypass surgery. Its impact has been significant in many patients, with long-lasting effects of up to 5 years.16

Many studies have shown that ECP can be of substantial benefit for some patients with CHF.3,4

Generally, they should only begin ECP therapy at least 6 weeks after surgical intervention and if their wounds have completely healed.

If their blood pressure is now under control, they may proceed with Renew™ ECP Therapy.

Renew™ ECP Therapy promotes blood circulation in the whole body, including in the limbs. However, if your patients have a severe obstruction of blood flow to their legs, they may not be suited for Renew™ ECP Therapy.

Some pacemakers may make it difficult for the ECP machine to synchronise with their heartbeats. However, "single-chamber" type pacemakers are generally accepted.

Certainly, patients may exercise before or after receiving Renew™ ECP Therapy.

Clinical studies have shown ECP to be effective with improving exercise capacity in patients with angina pectoris2. Many healthy people find Renew™ ECP Therapy to be beneficial after a vigorous workout. As ECP therapy improves blood flow to peripheral arteries17 and organs18, this can promote the removal of metabolites, such as lactic acid, thus helping in recovery from sports and exercise.

If the cuffs are not adjusted properly or the pressure is set too high for your patient, tenderness or bruising may occur. Extra padding can be arranged and the pressure setting can be adjusted to your patient's comfort.

Individuals with blood clots or past history of blood clots should not undergo Renew™ ECP Therapy.

If your patients have any conditions listed under the Contraindications, they should not undergo Renew™ ECP Therapy as well.

For athletic and wellness professionals:

Each individual must be cleared for ECP by their Healthcare Professional. ECP should not be done if any of the following are true:

  • Surgery in the six weeks before ECP session.
  • Cardiac catheterization in the two weeks before ECP session.
  • Irregular heart rhythm that could interfere with ECP inflation and deflation triggering.
  • Dual-chamber pacemaker (atrial component may interfere with ECP inflation timing sequence).
  • Aortic insufficiency (a heart valve problem).
  • Congestive heart failure.
  • Severe lung disease.
  • Circulation problems involving the legs or pelvis.
  • Current or past blood clot, venous thrombosis or thromboembolism.
  • Severe high blood pressure (≥ 180 mmHg systolic or ≥ 110 mmHg diastolic)
  • Bleeding disorder.
  • Anticoagulation (blood thinning) therapy with INR > 1.5.
  • Heart rates < 35 or > 125 beats per minute at the time of an ECP session.
  • Presence of infection, open wound, burn or fracture of the legs or pelvis.
  • Presence of aneurysm (aortic, cerebral or other).
  • Pregnancy. Women of childbearing age should have a negative pregnancy test when beginning ECP. Stop ECP if you become pregnant.

NOTE: The renew™ SPORT system is not a medical device. The ECG is not clinical grade and is not intended for diagnostic purposes.

The Renew™ External Counterpulsation devices have safety features that will ensure your patients experience a safe and beneficial treatment:

  • Inflation and deflation will stop and pressure in the cuffs will be released in any of these events:
    • If the heart rate is less than 36 BPM or more than 124 BPM
    • When your patient's ECG signal is not detected or reliable
    • If the PC is unable to display data
    • In the remote event of a power loss or system shutdown
  • The factory-set pressure relief valve prevents patient exposure to excessive cuff pressures
  • Should your patient suddenly feel uncomfortable during treatment, both the operator and patient can access an Emergency Stop button. Activating the Emergency Stop button will immediately stop the treatment.

For treatment of chronic stable angina, the established treatment time is 60 minutes per session. For other individuals, treatment duration may be advised by a healthcare professional.

For treatment of chronic stable angina, the established duration is 35 treatment sessions over 7 to 8 weeks (approximately 4 to 5 treatment sessions per week). For other individuals, treatment duration may be advised by a healthcare professional.

Clinical studies have shown that effects persist in some patients for up to 5 years.16

There are no age restrictions. However, minors require the consent of their parent or guardian prior to receiving Renew™ ECP Therapy.

References

  1. Yang, D.Y. and G.F. Wu, Vasculoprotective properties of enhanced external counterpulsation for coronary artery disease: beyond the hemodynamics. Int J Cardiol, 2013. 166(1): p. 38-43.
  2. Loh, P.H., et al., Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol, 2008. 31(4): p. 159-64.
  3. Feldman, A.M., et al., Enhanced external counterpulsation improves exercise tolerance in patients with chronic heart failure. J Am Coll Cardiol, 2006. 48(6): p. 1198-205.
  4. Abbottsmith, C. W., et al., Enhanced external counterpulsation improves exercise duration and peak oxygen consumption in older patients with heart failure: a subgroup analysis of the PEECH trial. Congest Heart Fail, 2006. 12(6), p. 307-311.
  5. Martin, J.S., et al., Enhanced external counterpulsation improves peripheral artery function and glucose tolerance in subjects with abnormal glucose tolerance. J Appl Physiol (1985), 2012. 112(5): p. 868-76.
  6. Martin, J.S. and R.W. Braith, Anti-inflammatory effects of enhanced external counterpulsation in subjects with abnormal glucose tolerance. Appl Physiol Nutr Metab, 2012. 37(6): p. 1251-5.
  7. Campbell, A.R., et al., Enhanced external counterpulsation improves systolic blood pressure in patients with refractory angina. Am Heart J, 2008. 156(6): p. 1217-22.
  8. Casey, D.P., et al., Effects of enhanced external counterpulsation on arterial stiffness and myocardial oxygen demand in patients with chronic angina pectoris. Am J Cardiol, 2011. 107(10): p. 1466-72.
  9. Braverman, D.L., et al., The safety and efficacy of enhanced external counterpulsation as a treatment for angina in patients with aortic stenosis. Clin Cardiol, 2013. 36(2): p. 82-7.
  10. Lin, W., et al., Predictors of good functional outcome in counterpulsation-treated recent ischaemic stroke patients. BMJ Open, 2013. 3(6).
  11. Han, J.H., et al., Preliminary findings of external counterpulsation for ischemic stroke patient with large artery occlusive disease. Stroke, 2008. 39(4): p. 1340-3.
  12. Applebaum, R.M., et al., Sequential external counterpulsation increases cerebral and renal blood flow. Am Heart J, 1997. 133(6): p. 611-5.
  13. Werner, D., et al., Enhanced external counterpulsation: a new technique to augment renal function in liver cirrhosis. Nephrol Dial Transplant, 2005. 20(5): p. 920-6.
  14. Froschermaier, S.E., et al., Enhanced external counterpulsation as a new treatment modality for patients with erectile dysfunction. Urol Int, 1998. 61(3): p. 168-71.
  15. Lawson, W.E., et al., Effect of enhanced external counterpulsation on medically refractory angina patients with erectile dysfunction. Int J Clin Pract, 2007. 61(5): p. 757-62.
  16. Lawson, W.E., J.C. Hui, and P.F. Cohn, Long-term prognosis of patients with angina treated with enhanced external counterpulsation: five-year follow-up study. Clin Cardiol, 2000. 23(4): p. 254-8.
  17. Braith, R.W., et al., Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation, 2010. 122(16): p. 1612-20.
  18. Werner, D., et al., Pneumatic external counterpulsation: a new noninvasive method to improve organ perfusion. Am J Cardiol, 1999. 84(8): p. 950-2, A7-8.

*"Technicians" in this website refer to qualified operators.