Vasomedical, Inc. - EECP® Therapy

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Product Overview

Why Vasomedical’s EECP® ?

In a sentence... It’s Good Medicine and Good Business.

Counterpulsation is a treatment method to increase blood flow in the body and reduce workload of the heart. External counterpulsation (ECP) is a term used to describe systems using a single hydraulic chamber wrapped around the lower extremities. Pressure is applied to the chamber during cardiac diastolic relaxation phase and removed during ejection systolic phase. The devices were inefficient and difficult to use. During the past 15 years, technological and clinical advancement led to the development of EECP® - Enhanced External Counterpulsation, the therapeutic systems exclusively designed and manufactured by Vasomedical with sequential pneumatic compression to increase retrograde diastolic flow, venous return and systolic unloading, greatly improve the ease of use, patient safety and clinical effectiveness.

Since the development of EECP®, an abundance of research has reviewed the mechanisms of action associated with the overwhelming positive benefits in patients who undergo a course of EECP® therapy. Only EECP has been proven clinically to produce the acute hemodynamic effects associated with increased diastolic augmentation, systolic unloading, and increased cardiac output, with a decrease in myocardial oxygen requirements. More recently, concrete evidence supports many of the hypotheses as to how exposure to EECP® treatment and its positive acute hemodynamic benefits can also recruit collateral blood vessels to ischemic regions, improve neurohormonal factors, improve endothelial function, reduce proinflammatory cytokines and adhesion molecules, and reduce arterial stiffness. All of these combined factors assist in the improvement of blood flow to ischemic regions and explain the life-changing clinical benefits observed in the majority of patients who undergo a course of EECP® therapy. Furthermore, it has been observed repeatedly that cardiac patients who undergo EECP® treatment have seen improvement in circulatory processes in systems other than cardiac (i.e. diabetic neuropathy, PVD, erectile dysfunction, etc…) and these findings will hopefully lead to more research to expand the indications for use of external counterpulsation not just for cardiac patients but for many patients who suffer from diseases of the circulatory system in the future.

EECP® (Enhanced External Counterpulsation) systems are FDA cleared non-invasive medical devices used as an adjunctive treatment for patients who suffer from coronary artery disease or ischemic heart failure. CMS (Centers for Medicare and Medicaid Services) reimbursement coverage has been provided for the use of ECP since 1999 for patients who have been diagnosed with disabling angina (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) and whom are not readily amendable for interventional procedures. EECP® therapy is a low-risk, cost-effective option for patients who suffer from coronary artery disease and its associated symptoms.

The specific features of Vasomedical’s EECP systems are:

• Clinical proven, evidence-based therapeutic systems documenting the effectiveness and safety of EECP® in the treatment of patients with coronary heart disease with:

› More than 150 published papers in world renounced medical journals
› 4 randomised, controlled prospective studies for the treatment of patients with
angina pectoris and heart failure
› 2 International patient registries of more than 8,000 patients monitoring clinical outcomes
and adverse events
› Clinical studies demonstrating the long-term effects with up to 5-year follow-up
› Numerous studies investigating the mechanisms of action of EECP® treatment

Only Vasomedical’s EECP® therapy is supported by randomized, controlled clinical studies published in peer reviewed medical journals. Most other manufacturers of external counterpulsation devices don’t have any published clinical evidence showing the efficacy of their device.

• Proprietary technologies with specific design providing safety and effectiveness with

› Specific electronic circuitry to reduce motion artifacts in provide stable triggering signals to operate in    synchronization with each cardiac cycle
› Application of optimal pattern in the external applied pressure to provide proven maximal hemodynamic    effects and reduce pulmonary congestion possibility
› Specific timing logics to limit inflation during systolic to avoid adding burden to the heart
› Incorporation of oximetry to monitor oxygen saturation to monitor patient safety
› Specific logics to handle arrhythmias, increase treatment effectiveness and reduce patient discomfort
› User friendly interface to provide operator with clear one page touch-screen operation manual to reduce    confusion and hazard to patients
› Easy to move single patented integrated system to provide mobility
› Specific designed inflation/deflation valves to increase rate of inflation and deflation to optimize    physiological effects
› ISO 13485 Annex II Certified quality process company with CE and UL certifications
› Manufactured according to EN 60601 Medical Electrical Equipment Part 1-4 Standard
› Software designed and tested according Medical Device Risk Analysis EN 149971

• Specific Training and Service Programs

› Expert certified quality operation training program to ensure safe and effective delivery of EECP®    therapy
› Specially trained and authorized service technicians to perform quality and on-time service to maintain    and repair EECP® systems
› Availability of quality Clinical Training Manual, Service Training Manual, as well as several clinical    presentations to physicians and patients

Vasomedical’s EECP® systems are the only systems that have been designed with years of research based upon real world technical and clinical know-how and we will continue to be the world market leader in providing noninvasive, safe and effective treatment to patients with cardiovascular disease.

Vasomedical EECP® Therapy

… Good for Your Patients

… Good for Your Practice

… Good for Business

Vasomedical offers four unique EECP therapy systems. Learn more about each one.

Lumenair™ EECP Therapy System
AngioNew-V Mobile EECP Therapy System
Model TS4 EECP Therapy System
AngioNew-VI EECP Therapy System