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The Ambulo 2400 Ambulatory Blood Pressure Monitoring System

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Presentation on theme: "The Ambulo 2400 Ambulatory Blood Pressure Monitoring System"— Presentation transcript:

1 The Ambulo 2400 Ambulatory Blood Pressure Monitoring System

2 Rationale for ABPM “White Coat Hypertension”
Anxiety of BP measurement in a clinical setting Can elevate measurements as much as points higher than normal An estimated 20% of the population exhibit this behavior (need reference) Enables BP measurement during a patients normal activities Provides a more complete picture of a patients hypertension profile Evaluation of medication resistant hypertension Enables measurement of BP over a wide range of time in order to evaluate medication effectiveness

3 Rationale for ABPM Evaluation of hypotension Nocturnal angina
Capture of events related to antihypertensive medications Nocturnal angina Investigate BP changes in patients during angina episodes Preeclampsia Evaluation of gestational hypertension or preeclampsia, especially in high risk pregnancies

4 Temperature & Humidity
Causes of BP Variance Temperature & Humidity Activity & Position Food & Beverage Lack of Sleep Medications Constipation Hormones Technique Mood

5 Blood Pressure Facts BP changes with activity and position
BP drops in most people when supine & surges in the morning Majority of heart attacks and strokes occur in morning hours Most clinical trials make an assumption that everyone goes to bed and wakes up the same time Incorrect calculation of BP results due to individual awake/asleep cycles impact on the quality of overall results

6 Blood Pressure Guidelines…
Critical marker in the determination of morbidity and mortality Sustained hypertension can cause heart attack, stroke, renal failure Hypotension J-curve risk Hypertensive 160 140 130 120 Hypertensive Systolic (mm/Hg) Borderline Pre-Hypertensive Normal

7 Challenges of ABPM Measurement accuracy Patient comfort
Must be able to accurately measure blood pressure readings in a variety of environments Should automatically determine sleep/awake cycles Must meet industry standards for clinical accuracy Patient comfort Size and weight should allow patients to perform normal daily activity Should operate quietly to allow normal sleep/awake patterns Batteries should be capable of continuous operation for a minimum of 24 hours Measurements captured and later uploaded for reporting and analysis

8 Challenges of ABPM Analysis Software Device configuration
Must be intuitive and require minimal training to operate Downloading measurements Generating graphs, reports and detailed statistics Comparison to previous measurements including automatic sleep/awake pattern synchronization Be HIPPA compliant Should be capable of installation on “off the shelf” PC based hardware Device configuration Should allow customization based on patient population Must require limited technical knowledge or expertise

9 Circadian Rhythm and BP Measurement
Heart rate and blood pressure both exhibit a strong circadian pattern with values for blood pressure, heart rate, and rate “Dippers” is used to describe patients whose nocturnal pressure drops at least 10% below their daytime pressure “Nondippers” is used to describe patients for whom the nocturnal decline in blood pressure is blunted or absent. Recent studies suggest that nondippers appear to have an increase in cardiovascular morbidity In both normotensive and hypertensive individuals, blood pressure and heart rate fluctuate according to both mental and physical activity levels, especially during wakefulness and sleep. In most hypertensive patients, there is a rather marked rise in blood pressure upon awakening that is called the morning or "a.m." surge

10 Examples of Circadian Profiles….
Normotensive Day: 128/79 Night: 110/62 Hypertensive Non-Dipper Day: 210/134 Night: 205/130 White Coat Office: 175/95 Day: 133/71 Night: 119/59

11 Approaches in BP Measurement
Home BP Office BP Ambulatory BP Central BP ECG Equivalent -- 12-Lead Holter Obtaining a BP measurement Yes Assessing White Coat & Masked Effects Limited Identifying Circadian Pattern No Identifying diurnal or nocturnal rhythm Identifying true or mean pressure Central Evaluating extent of nocturnal dip and morning surge Determining extent of variability Evaluation of response to treatment Determining time dependent effects of treatment – including Phase I cardiac safety trials Yes† Correlation of activity to BP Accuracy of recorded data Evaluation of central pressure, arterial stiffness and pulse wave velocity

12 Ambulo 2400 System…. Form Factor: Compact, durable and easy to use by patients and investigators which leads to better compliance & data Precise: Highly accurate, and robust oscillometric algorithm based on patented digital signal processing techniques Easy to Wear Options: Integrated on the blood pressure cuff, clipped on the hip or strapped around the shoulder Actigraphy: Automatic categorization of sleep/awake cycles based on patented technology reduces reliance on diaries Validated: Validated according to the AAMI SP-10 and ISO80601 standards plus British Hypertension Society’s protocols (A/A grade) including in pediatrics & adolescents Software: Sophisticated, intuitive and open software interface for easy programming, data download as well as report generation

13 Specifications…. Size Weight Measurement Ranges Measurement Accuracy
119 mm × 68 mm × 32 mm (4.7”x2.7”x1.2”) Weight 253 grams (9 oz.) Measurement Ranges Systolic 60 to 280 mmHg Diastolic 30 to 200 mmHg Pulse Rate 30 to 180 bpm Measurement Accuracy Blood Pressure:±5 mmHg mean diff. ±8 mmHg std. dev. Heart Rate: ±3 bpm Measurement Intervals Four adjustable intervals 0, 5, 10, 20, 30, 45, 60, 90, or 120 min. Optional randomization up to ±75% Optional Sequential Plans for Phase 1 Cardiac Safety Trials PC Interface USB cable with mini-B connector Cuffs Standard Adult, Large Adult & Child Optional EasyWear™ Adult Actigraphy Recording of 3-axis of motion via accelerometer Display & categorization of sleep/awake cycles via application software Memory Solid-state Flash technology. Sufficient for 2700 blood pressure measurements and 7 days of Actigraphy Batteries 2 AA batteries NiMH Current: 610mA (max); 1.3 mA (idle) 300 measurements using two 1600mAh NiMH batteries on regular adult cuff

14 Easy to Wear Options….

15 Independent Clinical Validation….
New global standard for development and validation of all blood pressure devices Clinical validation of Ambulo 2400 in 85 adults, adolescents and pediatrics Performed by Dr. Bruce Alpert of the University of Tennessee in Memphis Published in “Blood Pressure Monitoring” journal in Sept (PubMed ID: )

16 Importance of Actigraphy in ABPM….
The Problem The Solution BP changes with activity and position BP drops in most people when supine & surges in the morning Majority of heart attacks and strokes occur in morning hours Most clinical trials make an assumption that everyone goes to bed and wakes up the same time Incorrect calculation of BP results due to individual awake/asleep cycles has huge impact on the quality of overall results Built-in Actigraphy monitoring based on X, Y & Z accelerometer Automatic calculation of awake/asleep over 24 hour period No need for subject diaries Higher quality BP data

17 BP Profile of Patient… Systolic Dip 15% Asleep 10:00 PM Awake 7:00 AM

18 Corrected based on Actigraphy….
Systolic Dip 22% Asleep 02:10 AM Awake 9:10 AM

19 Ambulo 2400 Software…

20 Ambulo 2400 Software… Intuitive & Feature-Rich Solution For Windows® based platforms (XP, Vista & Windows 7) Allows for configuration of the device including “One Click Configuration”, testing and calibration Measurement download after the procedure Generation of detailed tabular, graphical and statistical data Support for AHA/JNC7 and ESH guidelines Special features for pediatric patients Customized reports in Microsoft® Word, HTML or PDF† formats Comparison reports between measurement sets including automatic sleep/awake pattern synchronization Data import/export in XML or CSV (Excel-compatible) Assist with HIPAA compliance Available in English, Spanish, French, Turkish, Greek, Finnish, Portuguese † PDF report generation requires 3rd party utility available for free

21 Global CPT & ICD-9 Codes….
CPT:  Ambulatory blood pressure monitoring; including recording, scanning analysis, interpretation and report. High blood pressure without hypertension (The only ICD-9 code covered by Medicare – Ranges from $60 – $90 for US patients) 796.2 Syncope, or near syncope 780.2 Weakness (generalized) 458.9 Hypotension, unspecified 785.50 Cardiovascular collapse 458.0 Orthostatic hypotension 402 Hypertensive heart disease 429 Cardiovascular disease due to hypertension 429.2 Resistant hypertension 997.91 Hypertensive renal disease 403.1 Unspecified hypertension complicating pregnancy 642.9 Transient hypertension of pregnancy 642.3 Mild preeclampsia 642.4 Maternal hypotension syndrome 669.2

22 Competitive Landscape

23 Global Competitive Landscape…
Manufacturer/ Product Mortara Ambulo 2400 SunTech Oscar 2† Spacelabs 90207 / 90217 A&D TM-2430 Size 11.9x6.8x3.2 cm 12x7x3 cm 11.4x8.6x2.8 cm 10x7x2.5 cm 10x7.2x2.7 cm Weight 253g 284g 347g / 255g 215g BP Algorithm Oscillometric Interface USB Serial / USB Serial/Modem/Printer Serial Configuration 4 Periods or Sequential Plans 3 – 6 Periods 4 Periods 6 Periods Validation Adult AAMI SP-10, BHS (A/A) & ISO AAMI SP-10, BHS & EHS AAMI SP-10 & BHS (B/B) 90207 BHS Grade: B, C & D AAMI SP-10 & BHS Validation Pediatric AAMI SP-10, BHS (B/B) & ISO AAMI SP-10, BHS (C/D) & ISO Actigraphy Yes - Cuffs & Replacement Costs 3 + EasyWear Optional disposables Regular & Large Regular + Large Batteries 2 NiMH AA’s 4 / 3 Alkaline AA’s 3 Alkaline or NiCad Memory Flash; BP’s & 7 days Actigraphy Flash; 250 BP’s ~250 BP’s, Battery Backed RAM 300 BP’s

24 Global Competitive Landscape…
Manufacturer/Product Mortara Ambulo 2400 SunTech Oscar 2 SpaceLabs 90207 / 90217 A&D TM-2430 Software Hypertension Diagnostics Suite AccuWin Pro v3 (WA: CardioPro) RMS DoctroPro Warranty 2 Years + Optional Damage Protection 2 Years + Extended (WA: 1 Year) 2 Years Origin USA USA/China Japan Mortara’s Advantages to Emphasize vs. Each Competitor No Actigraphy, expensive device and replacement cuffs; no support for clinical trials Dated technology; bad software; expensive device and replacement cuffs Dated technology; bad software; expensive replacement cuffs Competitor’s Key Claims & Advantages Soft Orbit Cuffs Distribution base Software Established Base in Clinical Trials Market Distribution base Aggressive pricing

25 Global Competitive Landscape…
Manufacturer/ Product Tiba Medical Ambulo 2400 IEM Mobil-O-Graph Microlife WatchBP 03 Size 11.9x6.8x3.2 cm 128mm x 75mm x 30mm 9.8x6.8x2.9 cm Weight 253g 240 g 240g BP Algorithm Oscillometric Interface USB USB and Bluetooth Configuration 4 Periods or Sequential Plans 7 Predefined, 2 variable 2 periods Validation AAMI SP-10, BHS (A/A) & ISO BHS (A/B), AAMI AAMI SP-10 ESH Actigraphy Yes No Cuffs & Replacement Costs 3 + EasyWear Optional disposables Sm. Adult, Adult, Lg, Adult - Batteries 2 NiMH AA’s 2 AA Medium & Large Memory Flash; BP’s & 7 days Actigraphy 300 4 AAA

26 Global Competitive Landscape…
Manufacturer/Product Mortara Ambulo 2400 IEM Mobil-O-Graph Microlife WatchBP 03 Software Hypertension Diagnostics Suite WatchBP Analyzer Warranty 2 Years + Optional Damage Protection 2 years monitor, 3 mos. Access. 2 Years Origin USA Germany Mortara’s Advantages to Emphasize vs. Each Competitor No Actigraphy, expensive device and replacement cuffs; no support for clinical trials No Actigraphy; not enough power to support long term or large arm measurements Competitor’s Key Claims & Advantages Blue-tooth capability, Client Server mgt sys, Suite of products- stabilo-graph for upper arm and clock- wrist bp, Auto Feedback Logic (dynamic inflate) Aggressive pricing based on Made in China

27 SunTech The SunTech Medical, Inc. patented Orbit cuff uses an innovative stretch-sleeve design to maintain cuff placement and promote patient comfort. The Oscar 2 is a light, compact monitor that uses motion tolerant algorithms to reduce re-inflates and failed readings. The auto-intelligent inflation pressure also reduces measurement time, promoting patient comfort by controlling cuff inflation. Weakness No Actigraphy, cost is higher than most

28 IEM Claimed Clinical Advantage
AFL (Auto Feedback Logic)* ensures unsurpassed measurement acceptance and patient comfort                                                  Individually adjusted cuff inflation (AFL) provides a key advantage for patients: the ability to enjoy an uninterrupted night’s sleep. This means that measuring blood pressure is faster and more patient-friendly. Wearer comfort (device compliance) is superior to that of competitor products, with correctly adjusted and washable one-hand cuffs. AFL* ensures a much better night’s sleep Weakness Pulse Wave velocity does not work according to several white papers addressing this study.

29 SpaceLabs Claimed Clinical Advantage
Fast, accurate results from Spacelab's ABP system enable you to fine-tune your patients’ treatment and better assess their cardiovascular risks. Its reliability has made it the #1 ABP monitor in the world, preferred by physicians and patients alike. Its latest software supports compliance with government requirements for integrity, availability, security and confidentiality of patient health information. Weakness The and ABPM devices have been available since 1995 with no apparent changes to the SW and the engineering team have all left SpaceLabs. Although at one time considered to be the “Gold Standard”, Many other companies have exceeded the BHS rating of SpaceLabs as the AMBULO 2400 received an A rating in all areas of both adult and pediatric while SpaceLabs has maintained a grade of B and C rating.

30 Current Clinical Research Customers…
Buffalo Clinical Research Center Netherlands Cancer Institute


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