PRODUCTS

PADnet+ is an easy to use system that uses automated means to obtain Ankle-Brachial Index (ABI)/Toe- Brachial Index (TBI) values and Pulse Volume Recording (PVR) waveforms. In just 15 – 20 minutes, during a regular office visit, the non-invasive ABI, TBI and PVR tests help identify obstructive disease and determine whether medical or surgical treatment is necessary.

Two mouse clicks sends the patient’s demographic, history, risk factors and test data quickly and securely, ensuring both speed and error-free transmission while maintaining HIPAA compliance.

PADnet+ saves time and travel to a hospital or specialty lab by sending test results instantly via the web for interpretation by a vascular specialist of your choice. Specialists can review results at their convenience, from any secure internet connection in the world.

Claims submission for 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.
 

PADnet+ Venous Testing
By the age of 50, nearly 40% of women and 20% of men have significant leg vein problems. An estimated 20 to 25 million Americans have varicose veins.*** This presents a significant opportunity for primary care and podiatric physicians.

The PADnet+ venous test is a non-invasive test that can be completed in just 5–10 minutes during a regular office visit. Venous refill testing helps identify problems affecting venous circulation and determine whether medical or surgical treatment is necessary.

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

PADnet+ seamlessly integrates with TRAKnet DPM Advanced Practice Management Solutions for a complete solution for your center of excellence.
Click here for more information about TRAKnet DPM


Easy to Use Reports
PADnet+ Arterial Study Report            PADnet+ Venous Study Report

Full color reports show PVR or Venous refill waveforms and test summary information.

 

 

*Information © 2006 P.A.D. Coalition
**Current Procedural Terminology (CPT®) is copyright 2007 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 American Medical Association. References to CPT codes herein are not intended to convey any endorsement or sponsorship by, or affiliation with, the AMA.
***Information © 2009 Venous Disease Coalition.

PADnet+ Remote View allows Physicians to login with a username and password provided by BioMedix to immediately view the results of a PADnet+ study at their convenience. Studies and reports can be accessed from any secure internet connection in the world, including from portable devices like the Apple® iPad™.

Remote View Access

• Access studies and real-time reports 24 hours per day, 7 days per week.
• Review test results anywhere, from any portable internet-capable device with a secure connection.
• Cost-effectively increase productivity and collaboration between users.

 

Easy to Use Reporting

• View and print online reports in the same format that is produced in exam rooms.
• 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.

 

“This feature 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

Supplied laptop specifications

• Intel® 2 Core 2 Duo processor or greater
• Minimum 2.0 GHz CPU speed or greater
• Minimum 3 GB RAM or greater
• DVD ROM drive included
• 56K fax modem
• 10/100 mbps network card
• Internet-ready

Hardware

• PADnet+ device
• Medical grade cart
• Pressure cuff kit
• Laptop

User interface

• Microsoft Windows XP, Vista or 7
• PADnet+ test software 

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 low cost 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 Device designed to do?
2.4. Is PADnet+ Venous Edition a clinically accurate and reproducible test?
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/Dermatologist?
2.8. …To a Podiatrist?
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 toll-free 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 over 10 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

Back to top

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.
Since PADnet tests are usually ordered for medically necessary reasons. 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 health care providers should review the applicable policies to confirm which specific ICD-9 diagnosis codes are covered.

Back to top

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.

Back to top

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 ACC/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 hand-held devices and duplex ultrasound or MRI. Use of hand held 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 and certified personnel.

Back to top

1.5. What advantages does PADnet+ have over low cost handheld Doppler Ultrasound devices?
Handheld Doppler Ultrasound devices are useful in certain baseline diagnostic tests, such as Ankle-Brachial Indices (ABI's). However, those that do not produce hardcopy reports or produce 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.
 

Back to top

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.

 

Back to top

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).

PADnet+ tests are usually ordered for medically necessary reasons. 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

Back to top

2.3. What is the PADnet+ Venous Device designed to do?
PADnet+ Venous Edition 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).

Back to top

2.4. Is PADnet+ Venous Edition a clinically accurate and reproducible test?
A PADnet+ venous test includes a thorough physical examination and automated 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.

Back to top

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”.

Back to top

2.6. Why is venous refill testing of interest to Vascular Surgeons?
Vascular surgeons are the primary managers of vascular disease, so their 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.

Back to top

2.7. Why is venous refill testing of interest to a Cosmetic Surgeon/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.

Back to top

2.8. Why is a venous refill test of interest to Podiatrists?
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.

Back to top

2.9. Is the PADnet+ Venous test comparable to Duplex Ultrasound?
PADnet+ is not comparable to duplex ultrasound, nor is it designed to be a replacement of 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.

Back to top

3. PADnet+ General FAQ
3.1. Who is qualified to use PADnet+?
Technicians performing PADnet+ tests are trained and certified on-site by well trained 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 probe steady over the artery of interest. PADnet+’s well established technology for segmental pressures does not use a probe, making it easier to operate than traditional ultrasound. Vascular specialists can perform readings at their convenience from any internet-equipped site.

Back to top

3.2. Is training provided?
Our comprehensive training includes a video tutorial, an in-service visit from qualified clinical personnel, and a technician certification program. A BioMedix in-service visit includes testing with pre-scheduled patients. A three-part technical training manual includes exams to test knowledge. The certification ensures that technicians have knowledge of peripheral vascular disease and diagnostic and therapeutic options, including PADnet+. In addition, performed are checked by BioMedix clinical staff for accuracy and completeness.

Back to top

3.3. Is toll-free customer service provided?
You can call our customer service department toll free at 888-889-8997 between 8 a.m. and 5 p.m. Monday - Friday, Central Standard Time. There is no limit to the number of calls you can make, provided your system is under a warranty contract.

Back to top

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. Operating manuals 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.

Back to top

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.

Back to top

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.

Back to top

3.7. How do I get additional information on PADnet+?
There are several ways you can receive additional information on our products. You can fill in the form located in our web pages, call our toll free number at 877-854-0014, fax us at 651-762-4014, provide us with mailing information at one of the many trade shows or symposia we attend, or e-mail us at sales@biomedix.com. Once your request is received we will send you information on our products and a representative will contact you.

 

Back to top

3.8. Can I order a PADnet+ System now?

Yes. Simply call our toll free number at 877-854-0014, and we will be happy to take your order over the phone.

 

Back to top

3.9. Can I lease the device?
Yes. We offer a range of leasing and financing options and can tailor one to your needs.

Back to top

“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.

“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+ 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


See additional video testimonials under the VIDEOS tab below.
 

Click to begin playing a video in a new window.

Contact our headquarters to connect with a BioMedix sales representative:

BioMedix Vascular Solutions, Inc. Corporate Sales
4215 White Bear Parkway
St. Paul, MN  55110
877-854-0014
sales@BioMedix.com