exclusive cardiocomfort™ treatment option the high
Transcription
exclusive cardiocomfort™ treatment option the high
THE HIGH TECH SOLUTION QUIETER AND SMALLER FEATURING: TRUMOBILITY ™ HEARTSMART FULL DISCLOSURE™ PATIENT RECORD S YSTEM 5 AND 10-LEAD ECG I NTEGRATED BP SP O2 C OMPATIBLE EXCLUSIVE CARDIOCOMFORT™ TREATMENT OPTION THE PIONEER CARDIOMEDICS TRACES ITS CARDIOMEDICS CARDIOMEDICS IS THE OF ECP RECEIVED ITS FIRST ECP TECHNOLOGY ROOTS TO THE IS THE FIRST CARDIOMEDICS IS THE FIRST COMPANY AT HARVARD FIRST FDA 510(K) CLEARANCE COMPANY WITH A CARDIOMEDICS 1960’S Q UIET, SMALL AND IN TRULY AND MIT 1987 PORTABLE SYSTEM COMPANY WITH A SYSTEM THAT REQUIRES LESS PRESSURE TO BE TO PROVIDE AN ERGONOMIC DESIGN THAT PIONEERING...YET AGAIN CARDIOCOMFORT ™ IS VERY THERAPEUTIC USER FRIENDLY 2 LEADING EDGE DESIGN FOR PATIENT AND OPERATOR INTERFACE 1 Operator selectable “Normal” or Exclusive CardioComfort™ treatment setting. 1 One set of cuffs fits virtually all sizes of patients. 1 The cuffs are easily adjusted for fit and positioning to maximize the patient’s comfort. 1 TruMobility™ portability - the entire system is self-contained, light in weight and truly mobile. 1 No “special bed” is required, though two optional beds are available. 1 Built-in Safety Features - total patient isolation with auto system alarm for high and low tank pressures, high and low cuff pressures and high and low heart rate. 1 19” fully articulated color monitor allows easy setup and adjustment before and during the procedure. 1 Optimized system design improves diastolic augmentation at lower cuff pressures improving patient comfort. CONTINUING TO L EAD THE WAY THE ONLY CE ACCREDITED TRAINING Peace of mind with the quality of your training The only training program that provides Continuing Education points for nurses and physicians. Peace of mind with your equipment investment First FDA clearance received in 1987, with subsequent 510(k)’s received in 2001, 2003 and 2005. Manufactured in the USA insures convenient parts and ser vice availability. Intel® Pentium® based PC Hardware platform runs on Embedded Windows® XP based software. Technical support provided by factory-trained technicians. Peace of mind with proven Financial Benefits Covered by Medicare and many health insurance plans. The treatment is far less costly than invasive procedures. CMS recently announced plans to reduce funds for invasive procedures and increase funds for alternative, effective, non-invasive procedures. 4 CONTINUING TO L EAD THE WAY R EAL PATIENTS...REAL RESULTS 5 CONTINUING TO L EAD THE WAY R EAL PATIENTS...REAL STORIES ECP TESTIMONIAL Lynn Butler, 57, had Coronary Arter y Bypass Surgery 14 years ago. However, like many diabetics, his grafts closed back up again. Since he was not a candidate for additional surger y or angioplasty, Mr. Butler was told by his Cardiologist to go home and take it easy. Adding to Mr. Butler’s burden was the psychological impact of his Cardiologist’s statement that nothing else could be done. His only option, or so he thought, was to sit at home, take his medicine and pray he would make it through another day. Although skeptical at first, after receiving 35 CardiAssist ECP treatments, Lynn is now living life again. It has been several years since he last took any nitroglycerin and he now works a 40 hour work week. Lynn is a firm believer in ECP saying, “I have my life back without drugs, surger y or angioplasty, it’s amazing.” 6 T ECHNICAL FEATURES: HEART SMART FULL DISCLOSURE™ PATIENT RECORD SYSTEM FULLY ARTICULATED 19” MONITOR - KEYBOARD/MOUSE I NTEGRATED BLOOD P RESSURE SYSTEM SP O2 COMPATIBLE 5 LEAD -3 CHANNEL 10 ECG LEAD-12 CHANNEL ECG SPACE E FFICIENT FOOTPRINT WHISPERQUIET™ OPERATION T RUMOBILITY ™ PORTABILITY LEADING THE WORLD IN PATIENT COMFORT WITH OUR NEW CARDIOCOMFORT PATIENT TREATMENT OPTION ™ 7 CONTINUING TO L EAD THE WAY R EAL PATIENTS...REAL RESULTS 8 CONTINUING CLINICALLY PROVEN WITH TO LEAD THE WAY PUBLISHED STUDIES FROM 1980 TO 2005 Clinical and Financial Benefits of ECP Published Clinical Benefits 1-5 The treatment regimen is well tolerated and comfortable even for very sick patients who cannot tolerate surgery or balloon angioplasty.1 Over 75% of patients improve (exercise times, reduction in anginal episodes, reduction in NTG, or improvements, in time, to ST depression).4 After treatment, many patients maintain their improvement (Angina Remission).4-5 Because the therapy is non-invasive, most patients continue to work or carry on normal activities. 4-5 The quality of life for many patients improves (functional capacity without crippling chest pain).4 Studies indicate benefits occur from improved diastolic flow, increased venous return and reduced afterload (Cardiac Output increases while oxygen demand remains the same).2 Excellent long-term prognosis (up to 5 years).4 9 10 CONTINUING TO LEAD THE WAY DEPENDABLE REVENUE STREAM BILLING CODES; MEDICARE, THIRD PARTY AND ICD-9-CM CODES MEDICARE BILLING HCPCS CODE: G0166-External Counterpulsation (Physician) APC CODE: 0972-External Counterpulsation (Hospitals) ICD-9-CM CODES: 413.0: Angina Decubitus 413.1: Prinzmetal Angina 413.9: Other and unspecified angina pectoris THIRD PARTY BILLING CPT 4 PROCEDURE CODES: 92971: CardioAssist - method of circulatory assist; external 93922: Noninvasive physiological studies of the upper or lower extremity artery 94761: Noninvasive ear or pulse oximetry for oxygen saturation; multiple determinations 99354-99355: Prolonged physician service with direct patient contact in an office or outpatient setting These codes repor t the total duration of face to face time spent by the physician on a given date, even if the time is not continuous. 11 Triggering Method Treatment Pressure Range Device Dimensions and Weight Precise, hardware generated Adjustable from 0 to 310 mmHg Trigger Range: 40-120+ bpm System Protection Height: Width: Depth: Weight: Cardiomedics Treatment Bed Options One main circuit breaker 36” wide treatment bed - 47 lb (21kg) Patient Protection 30” wide Electric Lift - 200 lb (90kg) • 12” height adjustment range, 25” to 37” Automatic inflation stop and release of pressure on early extra systole Voltage Requirements Automatic treatment stop and pressure release if power outage occurs 51” (130 cm) 24” (61 cm) 32” (82 cm) 350 lb (160 kg) Filter Technique Low-pass digital filter eliminates 50/60 Hz and high-frequency interference. Recommended Operating Environment Temperature: 120VAC/60Hz, 20A Automatic high-pressure limit 230VAC, 50Hz, 10A Integrated Bood Pressure Auto treatment stop if heart rate exceeds 120bpm or drops under 40bpm Relative Humidity: Atmospheric Pressure: Atmosphere: 50 to 140º F (10 to 40º C) 30 to 75% 700 to 1060 hPa Free of corrosive gas Transport/Storage Environment Pressure - range Systolic 90 to 220mmHg Diastolic 46 to 140mmHg Accuracy +/- 5mmHg (Standard Deviation 8mmHg or less) Cuffs Temperature: 1 Set - “one size fits all”: calf, thigh and buttocks Relative Humidity: Atmospheric Pressure: Atmosphere: 20 to 120º F (-6 to 50º C) 25 to 90% 500 to 1060 hPa Free of corrosive gas 1. Soran O, DeMarco T, Crawford L, et al. Enhanced external counterpulsation in management of patients with cardiovascular disease. Clinical Cardiology, 1999, 172-178 2. Amsterdam, E, Banas, J et al. Clinical assessment of external pressure circulator y assistance in Acute Myocardial Infarction, JACC, 1979 3. Urano, H., Ikeda, H. Enhanced external counter pulsation improves exercise tolerance, reduces exercise-induced myocardial ischemia and improves left ventricular diastolic filling in patients with coronar y artery disease, JACC, 2001 4. Lawson WE, et al. Benefit and safety of Enhanced External Counterpulsation in Treating coronary Arter y Disease Patients with a History of Congestive Heart Failure. Cardiology 12/2001 5. Weisfogel et al. External Counterpulsation Produces a Significant Reduction in Stable Angina Class, Episodes, Medication Use and Hospitalization. CVR&R 3, 2002 U.S. Patent number 4,388,919 Additional Patents pending. © 2005 Cardiomedics, Inc. All rights reserved Cardiomedics, CardiAssist, CardioComfort, HeartSmart, WhisperQuiet and TruMobility are trademarks of Cardiomedics, Inc. L0146 Rev B