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Non-invasive system for collaborative arterial and venous testing.

PADnet® is an easy to use in-office vascular testing device for the early detection of Peripheral Artery Disease (PAD) and venous disease, providing a platform that supports a continuum of care and increased quality outcomes. PADnet is clinically valuable, provides fair financial return with medically appropriate testing and seamlessly integrates with the complete suite of BioMedix® products and services for a comprehensive solution for your center of excellence.

OVERVIEW

Collaborative System that Connects Care Providers
PADnet saves time and travel to a hospital or specialty lab by sending test results instantly via the web for interpretation by a collaborating vascular specialist. Complete patient demographic, history, risk factor and test data is sent quickly and securely, ensuring error-free transmission while supporting HIPAA compliance. Specialists can review test results at their convenience, from any secure internet connection. Vascular disease can be detected earlier at front-line locations, limiting costly disease progression.

Peripheral Artery Disease
Eight to twelve million Americans have PAD. Without proper treatment, 30% are likely to suffer PAD-related stroke, heart attack, amputation or death.2 Detection and care for PAD can be dramatically improved by connecting physicians and vascular specialists to optimize collaborative patient care with the use of PADnet.

Comprehensive Vascular Testing Features
PADnet is more comprehensive, expandable and clinically valuable than ever before. PADnet is an all-in-one solution for your center of excellence.

  • Ankle-Brachial Index (ABI)/Toe-Brachial Index (TBI) and Pulse Volume Recording (PVR)
  • Also available:
    • Post-Exercise ABI and PVR testing help reveal masked disease
    • Segmental Pressures (pressures taken at thigh and calf levels) help localize disease
    • Venous Outflow testing via cuff to help determine the presence of proximal venous obstruction
    • Venous refill testing via cuff or probe to help identify problems affecting venous circulation and Chronic Venous Insufficiency (CVI)
    • Doppler-enabled module conveniently integrates external vascular Doppler functionality
    • Remote View allows physicians to review tests online 24/7

Program Launch Support
PADnet also includes complete onsite training by a BioMedix Clinical Specialist and a comprehensive Marketing Launch Kit to help you promote your services.

More Information (PDF):

PADnet Arterial Testing PADnet Venous Testing
PADnet for Vein Care

PADnet for Cardiologists

PADnet for Nephrologists

PADnet for  Endocrinologists
PADnet for Bariatric Specialists  

ARTERIAL TESTING

PADnet Arterial Testing
PADnet arterial testing uses a cuff-based method to record Ankle-Brachial Index (ABI)/Toe- Brachial Index (TBI) values and Pulse Volume Recording (PVR) waveforms. ABI and an assessment of flow are included in each test. Using PADnet, all major arteries in the ankle are occluded, and ABI is automatically calculated based on the highest pressure present.

PADnet uses recording oscillometry rather than mechanical oscillometry; as such, it records the oscillations detected by the plethysmograph, and processes those through an algorithm to determine the systolic/diastolic pressure

In just 15 to 20 minutes, during a regular office visit, the non-invasive tests help identify obstructive disease, and provide data to determine suitable medical or surgical treatment and guide an effective PAD treatment plan.

PADnet with Segmental Pressures
The Segmental Pressure testing capability adds pressures taken at above-knee and calf levels to more effectively diagnose vascular disease in the cardiovascular and vascular specialist office.

  • Helps confirm arterial insufficiency
  • Localizes results to specific vascular segments
  • Aids in identification of inflow disease
  • Identifies hemodynamically significant disease region to region
  • Insight into the locations of possible arterial blockages in the legs
  • Informed diagnosis increases treatment accuracy and efficiency, improving the quality of patient outcomes


User-Friendly Technology
Accessible technology enables physicians or credentialed technologists to perform testing in the office in just 15 to 20 minutes. The PADnet testing system is easy to use and intuitive. On-site training and a credentialing program is included.

Fair Financial Return
PADnet uses recording oscillometry and air-cuff plethysmography to report ABI and PVR measurements. PADnet tests meet the requirements for CPT® codes 93922, 93923 and 93924 (optional post-exercise testing), given approved physical signs and symptoms, providing a fair financial return.1

Study Result Reports
Color reports in printed and digital formats clearly show waveforms and test summary information.

Sample Arterial Study Report Sample Venous Study Report

Post-Exercise Testing

Post-Exercise Testing
Patients may have normal ABI findings but have reported leg pain. For patients with intermittent claudication, an abnormal ABI may only show up following exercise. To perform a post-exercise test, the patient will exercise until symptoms are induced. After exercise, the patient will lie down on the exam table and repeat the arm and ankle tests.

  • Can help reveal masked PAD
  • Aids in monitoring of disease progression over time
  • Can provide additional data for patients with symptoms not explained by initial test results


More Post-Exercise Information:

VENOUS TESTING

Lower Extremity Venous Issues
It is estimated that at least 20 to 25 million Americans have varicose veins, which can progress to cause swelling, skin changes and ulcers at the ankles or lower leg. Varicose veins are not just a cosmetic issue; Venus reflux, an underlying cause of painful varicose veins, can progress and cause advanced symptoms of CVI. CVI may affect up to 20% of adults.3 The opportunity to improve venous disease detection and care is significant.

PADnet Venous Testing
PADnet venous testing is non-invasive and can be completed in under 20 minutes during a regular office visit. Multi-method venous refill tests help identify venous incompetency and CVI, while venous outflow testing utilizing cuff-based air plethysmography helps determine the presence of venous obstruction. Users can complete venous refill testing using occlusion cuffs, probe technology, or both, to effectively support the detection of venous circulation issues, even in patients with advanced disease.

REMOTE VIEW

PADnet Remote View allows physicians to immediately view the results of a PADnet study at their convenience. Studies and reports can be accessed any time from any secure internet connection, including from portable devices like tablets and smart phones. Cost-effectively increase productivity and collaboration between users with this feature.


Convenient Reporting Access

  • View and print PADnet study reports
  • Filter and query studies by date
  • Batch print multiple studies at a time
  • Billing agents can choose to show only billed tests and can access billing reports, ICD-9 codes, CPT codes and modifiers

SPECIFICATIONS

PADnet Hardware

  • PADnet device
  • Cart
  • Pressure cuff kit
  • Laptop with PADnet test software installed

Supplied Laptop Specifications

  • Intel® 2 Core 2 Duo Processor
  • Minimum 2.0 GHz CPU speed
  • Minimum 3GB RAM or greater
  • CD ROM drive included
  • 10/100 mbps network card
  • Internet-ready
  • Windows® 7 Ultimate 32 bit

Minimum Laptop Specifications

  • Intel Pentium II Processor or equivalent (CPU 1.79 GHz)
  • RAM: 448MB (for XP) or 3GB (for Win 7)
  • 40 GB Hard drive
  • OS: Windows XP
  • Internet-ready
  • 1 free USB port for device
  • SVGA (set for 800x600)

FAQ


1. PADnet Arterial FAQ

1.1. How many people are affected by PAD?
1.2. What are the symptoms of PAD and who should be tested for PAD?
1.3. What is a PADnet Arterial test?
1.4. How does PADnet Arterial compare to other popular diagnostic tests?
1.5. What advantages does PADnet have over standalone handheld Doppler Ultrasound devices?

2. PADnet Venous FAQ

2.1. How many people are affected by CVI?
2.2. What are the signs and symptoms of CVI and who should be tested for CVI?
2.3. What is the PADnet venous test designed to do?
2.4. Is PADnet venous probe testing clinically accurate and reproducible?
2.5. Why would venous refill testing be of interest to a vein therapy center?
2.6. ... To a vascular surgeon?
2.7. …To a cosmetic surgeon or dermatologist?
2.8. …To a podiatric physician?
2.9. Can a PADnet Venous test be compared to a Duplex Ultrasound?

3. PADnet General FAQ

3.1. Who is qualified to use PADnet?
3.2. Is training provided?
3.3. Is customer service provided?
3.4. Is training on study interpretation provided?
3.5. Can I submit claims to payers for a PADnet study?
3.6. What is provided for in the warranty?
3.7. How do I get additional information on PADnet?
3.8. Can I order a PADnet system now?
3.9. Can I lease the device?

1. PADnet Arterial FAQ

1.1. How many people are affected by PAD?

  • PAD affects eight to twelve million people in the United States
  • Only a quarter of PAD sufferers are receiving treatment
  • Of the 2.5 million diagnosed cases, 2.1 million are medically managed

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1.2. What are the symptoms of PAD and who should be tested for PAD?
Patients should be tested for PAD if they have significant signs and/or symptoms of possible limb ischemia or if they are candidates for invasive therapeutic procedures.

When present in patients, medical records should include signs and symptoms such as the following:

Lower Extremity Symptoms:

  • Pain
  • Aching
  • Tightness
  • Tiredness
  • Weakness
  • Numbness in legs brought on by walking, and relieved by rest
  • Pain in legs/feet at rest
  • Poorly healing wounds
  • Reduced or absent pedal pulses

Findings from physical examination of the lower extremity:

  • Reduced or absent pedal pulses*
  • Presence of noises over arteries that can signify blockages
  • Feeling of aneurysm
  • Appearance of feet (skin condition, non-healing wounds)*
  • Hair loss*

*In some payer coverage policies, the absence of pulses, skin changes or loss of hair is not an indication to proceed beyond the physical examination unless it is related to other signs and/or symptoms.

Medicare and private payer reimbursement policies will vary, so healthcare providers should review the applicable policies to confirm which specific diagnosis codes are covered.

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1.3. What is a PADnet test?
A PADnet test is a non-invasive physiologic study which includes patient care required to perform the study, supervision of the studies, and interpretation of the study with copies for patient records or hard copy output results with analysis of all data. PADnet sends study data to a secure web server which supports HIPAA compliance for delivery to vascular specialists who provide professional interpretation.

Specifically, PADnet includes bilateral segmental pressures at multiple levels, and Pulse Volume Recordings (PVR) which provide waveforms to analyze the quality of blood flow. ABI values can sometimes be non-diagnostic due to arterial calcification. PADnet solves this problem because the PVR test can uncover disease in locations where arterial calcification masks the underlying problem.
Below is a brief description of each of the components of the PADnet test:

Segmental pressures: A test to evaluate and compare the systolic blood pressures in a patient’s arms and ankles (developing the Ankle-Brachial Indices, or ABI) as well as toes (Toe-Brachial Indices or TBI). The comparison of systolic blood pressures in a patient’s arms and great toe are often used in addition to or as a replacement of the ABI in patients with non-compressible vessels.

PVR (Pulse Volume Recording): PVR waveforms are plethysmographic tests which provide qualitative information. Simply put, a blood pressure cuff is inflated to a level that does not interrupt arterial flow (approximately 65 mmHG). As each arterial pulse passes through the segment of artery beneath the cuff, the volume of blood causes distention of the artery. This is sensed by the cuff, which then transmits a volume change to a recorder (BioMedix PADnet), providing a waveform.

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1.4. How does PADnet compare to other popular diagnostic tests?
PADnet segmental pressures (used for ABI measurement) and Pulse Volume Recordings (PVR) are technologies that have been in use for 30 years. PVR is complimentary to segmental pressure indices, and according to ACCF/AHA Clinical Guidelines, is quite useful in patients with non-compressible vessels (ABI values greater than 1.3). The following data from the American Medical Association compares the ABI to other common diagnostic tests.

 

Diagnostic Test

Sensitivity %

Specificity %

Pap Smear

30-87

86-100

Fecal Occult

37-78

87-98

Mammography

75-90

90-95

ABI

95

99


Alternatives to PADnet include handheld devices and duplex ultrasound or MRI. Use of handheld devices which do not produce hard copy, or a record of bi-directional vascular flow is considered part of the patients physical exam and will not be separately reimbursed. Duplex Ultrasound or MRI, on the other hand, while providing excellent results is expensive, operator dependant, and must be performed in a vascular lab. Bilateral segmental pressures and PVR testing using PADnet is easily performed by trained personnel.

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1.5. What advantages does PADnet have over standalone handheld Doppler Ultrasound devices?
Handheld Doppler Ultrasound devices are useful in certain baseline diagnostic tests, such as Ankle-Brachial Indices (ABIs). However, those that do not produce hardcopy reports or a waveform are considered part of the patient's physical exam and therefore do not meet the medical necessity study guidelines of most payers. Also, if this data is not stored in a computerized database it is of limited usefulness in communicating with patient electronic medical records. Since PADnet has the optional ability to integrate with an external vascular Doppler device, you can utilize this technology in combination with PADnet's advanced capabilities for the most complete vascular testing solution.
 

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2. PADnet Venous FAQ
2.1. How many people are affected by CVI?
Chronic Venous Insufficiency (CVI) is another under-diagnosed and significant health problem in the US, affecting over 10 million of the rising population. Approximately 24 million Americans have varicose veins, 6 million have skin changes associated with CVI and venous stasis ulcers affect 500,000 people. In addition to poor cosmesis, CVI can lead to chronic, life-threatening infections of the lower extremities.

 

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2.2. What are the symptoms of CVI and who should be tested for CVI?
Patients should be tested for CVI if they have significant signs and/or symptoms of possible venous valve incompetence or if they have a family history of Deep Vein Thrombosis (DVT).

When present in patients, medical records should include signs and symptoms such as the following:

Lower Extremity Symptoms:

  • Leg heaviness, aching, cramps and tiredness
  • Ankle and leg swelling
  • Varicose veins
  • Spider veins
  • Pain in legs after long periods of standing or sitting
  • Ulceration or skin breakdown

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2.3. What is PADnet venous testing designed to do?
PADnet venous testing is a diagnostic tool for primary diagnosis of insufficiencies and incompetence (damaged valves that no longer close properly) of the superficial venous system. It can identify only the presence or absence of disease. It is not intended to find the severity, location or source of reflux, the backward flow of blood. (eg, saphenofemoral junction, saphenopopliteal junction, perforators) tributaries, vein size, or vein morphology. It is not a method of detecting Deep Vein Thrombosis (DVT).

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2.4. Is PADnet venous probe testing clinically accurate and reproducible?
A PADnet venous test includes a thorough physical examination and a diagnostic procedure utilizing clinically proven optical probe (photoplethysmography (PPG) technology). The PPG is used to assess the circulatory hemodynamics, or motion of blood in the skin by gauging the perfusion, or transportation of blood and reflux of blood in the lower limb. The venous refill test is a reliable indicator of venous valvular insufficiency. PADnet was tested for substantial equivalency against existing vascular lab equipment performing similar tests (venous refill exam) and was found to be substantially equivalent to such equipment.

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2.5. Why would venous refill testing be of interest to a vein therapy center?
Even experienced vascular surgeons and vein specialists find it difficult to decide the exact source of chronic venous insufficiency and where the problem lies without the use of diagnostic equipment. This is especially true when varicose veins have recurred after a previous operation. The goal of diagnostic testing is to assess the physiological venous function and to visualize and identify areas of acute or chronic insufficiencies and areas of reflux within the venous systems. In addition, duplex imaging tests can take up to 1-2 hours to perform for each patient. PADnet venous testing can rule out “normal” patients and can allow for higher level testing of the “abnormals”.

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2.6. Why is venous refill testing of interest to vascular surgeons?
Vascular surgeons' care encompasses both arterial and venous disorders. With PADnet venous testing, vascular surgeons can benefit by helping to identify patients within their primary physician referral networks who have treatable venous disease.

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2.7. Why is venous refill testing of interest to a cosmetic surgeon or dermatologist?
Chronic Venous Insufficiency is unsightly and can reduce self-esteem. Many people have endovascular laser treatments performed by cosmetic surgeons or dermatologists to remove varicose veins. While the a patient’s motivation to treat CVI may be for cosmetic reasons, from the physician’s standpoint, a clinical validation of CVI may suggest further studies are needed to determine if there is a more serious underlying cause for the disease.

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2.8. Why is a venous refill test of interest to podiatric physicians?
Podiatric medicine is devoted to the study and treatment of disorders of the foot, ankle, and sometimes, the knee, leg and hip. Podiatric physicians closely examine the lower extremity and are often most likely to notice signs and symptoms of Chronic Venous Insufficiency. Also, podiatric physicians treat foot ulcers and need to be able to differentiate if the underlying cause is arterial or venous related.

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2.9. Is the PADnet venous test comparable to duplex ultrasound?
PADnet is a user-friendly baseline test that is not designed to be a replacement for duplex ultrasound. Traditional diagnosis for CVI involves the use of venous ultrasound, and operation of this equipment requires extensive training and technical skill. PADnet venous tests can be performed in the primary care setting and the technicians are quickly and easily trained by BioMedix Clinical Specialists.

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3. PADnet General FAQ
3.1. Who is qualified to use PADnet?
Technicians performing PADnet tests are trained on-site by BioMedix clinical personnel via a curriculum which is nationally recognized. High quality and reproducible PADnet studies by non-physicians are possible because of the sophisticated technology used in PADnet. Segmental pressures are not routinely performed in primary care settings because of the difficulty of holding a doppler probe steady over the artery of interest. PADnet is easier to operate than traditional ultrasound. Vascular specialists provide expert interpretation of study results from any internet-equipped site.

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3.2. Is training provided?
Our comprehensive training includes an in-service visit from qualified clinical personnel and a technician credentialing program. A BioMedix in-service visit includes testing with pre-scheduled patients. A three-part technical training manual includes exams to test knowledge. The training ensures that technicians have knowledge of peripheral vascular disease, patient selection and diagnostic and therapeutic options. In addition, tests performed for training are checked by BioMedix clinical staff for accuracy and completeness. Read more about our credentialing partnership with ACFAOM.

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3.3. Is customer service provided?
You can submit questions via email to Support@BioMedix.com, or use the online support contact form. You can also call BioMedix Customer Service toll-free at 888-889-8997 between 8:00am and 6:00pm Monday - Friday, Central Standard Time (excluding holidays).

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3.4. Is training on study interpretation provided?
Training on study interpretation is provided to both test site personnel and reading specialists. When studies do not meet expectations, technicians can review and restart the test. User guides help distinguish between normal and abnormal exams. BioMedix personnel will answer specific questions on interpretation of studies and will provide links to sources of continuing education on vascular study interpretation.

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3.5. Can I submit claims to payers for a PADnet study?
In general, Medicare and private payers cover diagnostic tests when medically necessary. When the medical record reflects significant signs and symptoms of possible limb ischemia in a patient who may be a candidate for an invasive therapeutic procedure, a PADnet test is appropriate and in most cases is eligible for reimbursement. Local medical policies describing acceptable signs and symptoms for a study will vary by payer, so providers are encouraged to consult their local insurance providers to confirm applicable coverage and payment rules.

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3.6. What is provided for in the warranty?
The BioMedix system is warranted for 3 years for all parts and labor when used under normal operating circumstances. BioMedix supplied laptop computers have a 1 year warranty as provided by the original equipment manufacturer. For other components, please see the Terms and Conditions section of our website.

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3.7. How do I get additional information on PADnet?
There are several ways you can receive additional information on our products. You can submit an information request online, call our toll-free number at 877-854-0014, fax us at 651-762-4014, speak with us at a local tradeshow, or email us at Sales@BioMedix.com. After your request is processed, you'll receive additional information on our products and a BioMedix representative will get in touch with you.

 

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3.8. Can I order a PADnet system now?

Yes. Call our toll free number at 877-854-0014, and we will be happy to take your order over the phone. We do not currently process orders for medical equipment over the internet.

 

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3.9. Can I lease the device?
Yes. We offer a range of leasing and financing options and can tailor one to your needs. Get in touch with us at sales@BioMedix.com, and we'll see what works best for you!

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TESTIMONIALS

"PADnet has been indispensable diagnostic instrument in my medical practice. I have been able to detect Peripheral Vascular Disease in its early stages of development and prevent its further progression."
David Kavesteen, MD
Heart and Health
North Babylon, NY

 

“I considered other technologies, but was put off by techniciandependency and the burden of interpreting the test results inhouse. PADnet is quick, easy to use and provides the opportunity to collaborate with a vascular expert, which allows me to treat my patients with confidence.”
Dr. Kim Gauntt, DPM
Hillsboro, OR

 

“PADnet allows us to make an early diagnosis of peripheral vascular disease in a primary care setting. It provides financial reimbursement that makes sense. And a unique feature of PADnet is its ability to break down barriers between specialists and primary physicians. BioMedix will come in and train your staff. That makes a huge difference. They provide that comfort level with testing, and once they get that, they are off and running.”
John D. Martin, MD, Vascular Surgeon
Annapolis, MD

 

“The PADnet vascular exam system requires NO hand-held Doppler, and, for the most part, is much easier to perform while giving the physician a lot more detailed information including: PVRs (multiple level) ABIs and TBIs.  Overall, [it is] much less technician dependent with much better reporting. The results can read by a vascular specialist of your choice via the Internet helping to increase referrals and reduce liability.”
Hal Ornstein, DPM
Chair, American Academy of Podiatric Practice Managers,
Howell, NJ

 

“PADnet with Segmental Pressures provides another reference to assist in identifying Peripheral Vascular Disease in a non-invasive practice setting. PADnet finds patients earlier, when interventional options and treatment possibilities are at their greatest.”
John Martin, MD
Medical Director of Heart and Vascular Institute at Anne Arundel Medical Center
Annapolis, MD

 

“This feature [Remote View] helps support the way we work. Three of our five offices are part of multi-specialty groups. I can test a patient in one office, and review the results with a specialist in another office without having to carry copies with me. I will also use this feature whenever I visit with my Hospital wound care clinic colleagues, to plan care for my patients.”
John Guiliana, DPM
Hackettstown, NJ

 

“PADnet is a simple and clinically useful test for the diagnosis of CVI.”
Dr. Tom Fogarty
Inventor of the medical industry standard balloon embolectomy catheter.


See additional video testimonials under the VIDEOS tab below.
 

VIDEOS


Click to begin playing a video in a new window.



John Guiliana
Hal Ornstein
Benjamin Weaver
Jonathan Moore
Allison DeWaters-LaBianca

PURCHASE NOW

Contact our headquarters to connect with a BioMedix sales representative:

BioMedix Corporate Sales

877-854-0014
sales@BioMedix.com



Source: ML-043, ML-188, ML-195. 1. Current Procedural Terminology (CPT®) is copyright 2012 American Medical Association (AMA). All rights reserved. No fee schedules, basic units, relative values or related listings are included in CPT. the AMA assumes no liability for the data contained herein. CPT is a registered trademark of the AMA. References to CPT codes herein are not intended to convey any endorsement or sponsorship by, or affiliation with, the AMA. 2. Vascular Disease Foundation. (2012). Peripheral Artery disease. http://vasculardisease.org/peripheral-artery-disease/. 3. Vascular Disease Foundation. (2012). Chronic Venous Insufficiency. http://www.vasculardisease.org/chronic-venous-insufficiency-cvi/. The information provided on this website was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules and policies. All content on this website is informational only, general in nature, and does not cover all situations or all payers’ rules and policies. This content is not intended to instruct medical providers on how to use or bill for healthcare procedures including new technologies outside of Medicare national guidelines. A determination of medical necessity is a prerequisite that BioMedix assumes will have been made prior to assigning codes or requesting payments. Medical providers should consult with appropriate payers, including Medicare fiscal intermediaries and carriers, for specific information on proper coding, billing and payment levels for healthcare procedures. This website represents no promise or guarantee by BioMedix regarding coverage, coding, billing, and payment levels. BioMedix specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information on this website. PADNET: U.S. PATENTS 7,983,930; 8,229,762 B2; 7,214,192; 7,172,555; 7,166,076 & PATENTS PENDING.

 

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