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Medilux Healthcare Limited - Epsican® Dermal Ultrasound Scanner - Brochure
           - Short version [ two pages]

Medilux Healthcare Limited - Epsican® Dermal Ultrasound Scanner - Brochure
          - Long version including further clinical information and references. [ 4 pages].

Medilux Healthcare Limited - Epsican® Dermal Ultrasound Scanner
         - Techonology and Applications

The British Broadcasting Corporation [The BBC] features Episcan®
in news reporting www.tissueviability.org/content/default.asp?PageId=128

Medicare Says It Won’t Cover Hospital Errors
WASHINGTON, Aug. 18 — In a significant policy change, Bush administration officials say that Medicare will no longer pay the extra costs of treating preventable errors, injuries and infections that occur in hospitals, a move they say could save lives and millions of dollars. to read article

News
EPISCAN Cost Benefit Results Presented at 20th Annual Symposium on Advanced Wound Care and Wound Healing Society Meeting, April 2007
A poster entitled “Cost-Benefit of the EPISCAN Ultrasound System in Extended Care Rehabilitation Units” was presented by Ronald J. Shannon, MPH at the above meeting. The conclusions presented are:
“We conclude that EPISCAN, in extended care rehabilitation units, is a cost-benefit to providers for preventing costly pressure ulcers. The expected cost savings for the at-risk patient is approximately $5,300.00 per resident over a 1 year period. The decision to use EPISCAN was very robust and changed only when the incidence of pressure ulceration was below 3.0% in the standard evidence-based group. When used routinely, the EPISCAN skin ultrasound diagnosis will be cost-effective approximately 74% of the time.”

Impact of EPISCAN in Long Term Care
– Customer’s Prospective

The April 2007 addition of Provider Magazine contained an article entitled “A New Look at Pressure Ulcers” written by BILL OSMAN, RN, Director of Nursing and MAX H. KERNODLE, Administrator of Presbyterian Home of Hawfields, Mebane, N.C this article reflects the impact the EPISCAN has had on their facility. The article contains the following statements
“The incidence of pressure ulcers at Hawfields had dropped to 2 percent in February 2007, from 7 percent in September 2005, and the nurses’ treatment time has been better utilized in other direct-care patient issues such as teaching, documentation, and assessment-related procedures.”
“Due in part to the decrease in incidence of pressure ulcers, liability insurance rates were decreased upon renewal. Incorporation of this new technology has drastically decreased the pain and suffering of the patients at Hawfields and possibly saved thousands of dollars in wound-treatment costs. It is even possible that the facility may have circumvented costly lawsuits.” read article. . . .

A New Weapon Against Pressure Ulcers - Handout
Download Longport’s latest handout on the use of the EPISCAN in pressure ulcer prevention here.

Wesley Health Care Centre Comment on their Experience with Longport’s EPISCAN

The Wesley Health Care Centre, The Wesley Community’s skilled nursing facility, in Saratoga Springs, NY, USA comment on their involvement in a cost benefit analysis study including their experience using the EPISCAN for the early detection and prevention of pressure ulcers. Read Article...

Longport Technology Obtains Extended FDA Marketing Clearance

Longport Inc announced on December 8, 2006 that its EPISCAN high resolution ultrasound scanner had gained additional FDA marketing clearance. (see also associated press release of December 8th) The full text of this new clearance, FDA reference K062571, can be viewed and downloaded from the FDA web site through the link below.
http://www.fda.gov/cdrh/pdf6/K062571.pdf
Longport had previously obtained FDA marketing clearance for its technology through FDA clearance reference K990238.
Importantly this new marketing clearance includes a broad range of specific indications of use for our technology, as presented in the statement below.
“The EPISCAN I-200 high-resolution ultrasound system is a specialized system for imaging the skin and underlying soft tissue. It is intended for use by clinicians, or under the direction of physicians for imaging and analysis in research environments as well as clinical settings including medical / surgical dermatology assessment and diagnosis (aesthetic and therapeutic), plastic / reconstructive surgical planning, wound assessment and management, skin assessment for pressure ulcer detection and prevention and superficial musculoskeletal diagnosis.”
The clinical applications cleared for specific transducers that operate with Longport’s EPISCAN high resolution ultrasound scanner include:


wound management and assessment
detection and prevention of pressure ulcers
detection of deep tissue injury
burn depth assessment
superficial musculoskeletal assessment
skin lesion assessment
aesthetics

A paper presenting the high frequency ultrasound pathology of pressure ulcers and the utility of this technology in the early detection of pressure ulcers published in Advances in Skin and Wound Care
Use of High-Resolution, High-Frequency Diagnostic Ultrasound to Investigate the Pathogenesis of Pressure Ulcer Development.

Abstract:

OBJECTIVES: To investigate the pathogenesis of pressure ulcers utilizing high-resolution ultrasound and to explore the utility of this technology for the detection of incipient pressure ulcers prior to visual clinical signs.

DESIGN: An observational prospective study comparing high-resolution ultrasound images obtained from 119 long-term-care facility residents determined to be at risk for pressure ulcer development (Braden Scale score of 18 or less) with images obtained from 15 healthy volunteers (medical students and medical residents). Common pressure ulcer sites were scanned, including the heels, sacrum, and ischial tuberosity.

SETTING: A medical center and a long-term-care facility.

INTERVENTION: Anatomic sites universally accepted as at risk for pressure ulcer development were scanned using high-resolution ultrasound; the sites did not have visual evidence of skin breakdown. The images obtained from the long-term-care facility residents were compared with images considered normal that were obtained from healthy volunteers. In addition, documentation of the clinical assessment finding for erythema was reviewed, recorded, and compared with the high-resolution ultrasound finding for each specific site.

MEASUREMENTS: The images obtained were classified as not readable, normal, or abnormal. The images classified as abnormal were further classified by depth of abnormal finding: pattern 1 (deep) or pattern 2 (superficial). The images classified with the abnormal finding pattern 1 (deep) were further classified and subdivided by anatomic location of abnormal finding(s): subgroup 1, abnormal findings in the subdermal area only; subgroup 2, subdermal and dermal abnormal findings; and subgroup 3, subdermal, dermal, and subepidermal edema. Pattern 2 (superficial) included images with abnormal findings limited to the dermal/epidermal junction.

RESULTS: 630 (55.3%) of the images obtained from the long-term-care residents were different from the images obtained from the healthy volunteers. The healthy volunteers' images classified as normal had the expected ultrasound findings for homogeneous pattern of ultrasound reflections, allowing for visualization of various skin layers (epidermis, superficial papillary dermis, deep reticular dermis, and hypodermis) and subcutaneous tissue (subdermal). However, many images (55.3%) obtained from the residents at risk for pressure ulcer development had patterns where areas within the various skin layers were not visible, interrupted by areas indicative of fluid or edema. Moreover, most images (79.7%) with abnormal ultrasound patterns did not have documentation of erythema.

CONCLUSION: High-resolution ultrasound is an effective tool for the investigation of skin and soft tissue changes consistent with the documented pathogenesis of pressure ulcers. A progressive process for pressure ulcer development from deep subdermal layers to superficial dermal then epidermal layers can be inferred. Dermal edema was only present with subdermal edema. In other words, there was never evidence of dermal edema in the absence of subdermal edema. A better understanding of the pathogenesis of pressure ulcers through the use of high-resolution ultrasound to detect soft tissue damage and edema before visible clinical signs could lead to earlier and more focused pressure ulcer prevention programs, resulting in reduced pain and suffering for improved patient quality of life and wound care cost savings.


Advances in Skin & Wound Care. 19(9):498-505, November/December 2006.

Quintavalle, Paul R. DPM; Lyder, Courtney H. ND, RN; Mertz, Philip J. PhD, CWS, FCCWS; Phillips-Jones, Connie MSN, RN; Dyson, Mary PhD, FAIUM, FCSP

Wound assessment study using Longport’s technology reported in British Journal of Nursing


Has Packing Sinus Wounds Become a Ritualistic Practice?
British Journal of Nursing - Volume 15, Number 19: 26 October-8 November 2006. Tissue Viability Supplement, pages S27-30

Andy Kerr, Steve Young, Sylvie Hampton

Abstract
Wound healing is both a science and an art, and modern advances in wound management are ensuring that advanced clinicians use both clinical knowledge and experience when deciding on wound dressings and therapies. When there is a lack of evidence, then selection of dressings or therapies becomes extremely difficult and inappropriate treatment can occur. This is generally the situation with sinus wounds. There is very little evidence available to help decide on suitable dressings for these intractable wounds. The use of high frequency ultrasound (HFU) can help to guide practice on whether or not to pack sinus wounds. This article will explore the potential of ultrasound use by describing a case study of a patient with a sinus wound where HFU was used to examine the sinus and inform the practitioners on the appropriate choice of wound dressing.

Key Points
When there is a lack of evidence, then selection of dressings or therapies become extremely difficult and inappropriate treatment can occur.
The use of high frequency ultrasound (HFU) will help to guide practice on whether or not to pack sinus wounds.
Would assessment falls into two main categories, invasive and non-invasive: invasive methods generally involve biopsy, which destroys the tissue.
High frequency ultrasound could be used to image and quantify changes in the wounds as a means of non-invasively visualizing wound characteristics which would otherwise be missed using standard visual assessments alone.


See also related story directly below:

Wound Assessment Use of Longport’s Technology

Tissue Viability Consultancy Services (TVCS) recently presented the use of Longport’s technology on BBC South East News to view this news item use the link below:

www.tissueviability.org/content/default.asp?PageId=128


British Journal of Nursing - Volume 15, Number 19: 26 October-8 November 2006. Tissue Viability Supplement, pages S27-30

Longport Technology & Mount Sinai Study Poster Presented at Annual Meeting of American Society of Dermatologic Surgeons

Longport presented its high resolution ultrasound technology at the annual meeting of the American Society of Dermatologic Surgeons (ASDS). Also, at this meeting Eric Berkowitz, MD of Mt Sinai Medical Center, New York, NY presented a poster entitled “The Use of High Frequency High Resolution Ultrasound Prior to Mohs Surgery”
Author: Eric Zachary Berkowitz, MD
Mt Sinai Medical Center, New York, NY
Title: The Use of High Frequency High Resolution Ultrasound Prior to Mohs Surgery
Co-Authors: Ellen Marmur MD, Josh Zeichner, MD, Mohammad Al-Hadab, MD, Jodi Siskind, MS, Brian Fuchs, BA, Connie Phillips-Jones, RN, MSN
Purpose: The use of ultrasound (US) to examine and assess the skin is a relatively new technology. Ultrasonography utilizes the echoes of sound waves to create images of soft tissue anatomy. The object of this study is to explore the clinical application and use of high frequency high resolution ultrasound in Mohs micrographic surgery. Additionally, the study will evaluate the ability to accurately determine lesion depth and width of tumor borders in order to reduce the number of surgical stages and possibly leading to a smaller defect.
Design: Single center study of twenty patients scheduled for Mohs surgery with lesions on flat surfaces (chest, back, extremities and face). The investigator will demarcate and document clinical estimation of the first stage. Ultrasound images will then be taken and depth and diameter will be documented, extirpation of tumor and histological analysis will be performed using standard Mohs technique. Statistical analysis will be performed via a Student‘t’ test for differences.
Summary: The effectiveness of the ultrasound within the context of Mohs surgery and Mohs stages, the tumor size that was predicted by the ultrasound in comparison to clinical evaluation had interesting results. Of the twenty-two patients, 6 patients or 27% of the patients had ultrasound measurements that were either similar or smaller than the initial clinical measurement of the tumor (2/6 were Squamous Cell Carcinoma - SCC and 4/6 were Basal Cell Carcinoma - BCC) but, required multiple stages of Mohs surgery (2-4 stages). This indicates that the initial ultrasound measurements predicted a smaller cancer when in reality the cancer was larger. Alternatively, another subset of the study, 6/22 or 28% of patients were found to have larger ultrasound measurements of their cancer (4/6 were SCC and 2/6 were BCC) when compared to the clinical measurement, yet histologically only required one Mohs stage. It is difficult to say which measurement is more accurate in this case; it may be implied, that in this situation the clinical is more accurate because the US prediction was larger than the clinical measurement and still only one Mohs stage was needed. Therefore, if you had taken the stage according to the US measurement it would have been larger than necessary. Finally, in 12/22 or 54% of patients, the ultrasound measurements were smaller than the clinical measurements, but the tumor still only required one stage of Mohs for complete extirpation. The scenario does not enable us to determine which method is more accurate.
A paired 2-sided t-tests testing for differences between clinical and US widths and lengths was performed and found: width: t=-2.189 (p=0.040) length: t=-1.427, (p=0.168) indicating that there is a significant difference between the widths found from clinical assessment vs. ultrasound; implying that the widths found clinically tend to be larger. Conversely, there was no significant evidence to suggest a difference between the lengths found from clinical assessment vs. the ultrasound.
Conclusion: The use of high frequency ultrasound using 20 MHz transducers has been established for the noninvasive imaging of skin tumors. We found that it has the ability to detect a more precise measurement of the width of a cancer enabling it to be used adjunct for preoperative planning with regard to surgery, especially in areas where there is a need to preserve normal skin.


This meeting took place between the 26th and 29th of October 2006 in Palm Desert, California, USA.


Longport International Leads DTI Supported Project To Develop High Performance Ultrasound System

Longport International, Ltd., is participating in a £1.1 million project supported by a Department of Trade & Industry grant to develop a high resolution phased array ultrasound imaging system. The system will be capable of imaging at centre frequencies greater than 25 MHz as well as at lower frequencies and is expected to exceed the imaging resolution of all current commercial multi-element ultrasound systems.

The project, which is led by Longport International, involves the University of Manchester, Phoenix Inspection, a supplier of industrial inspection systems, and Newbury Electronics, a manufacturer of printed circuit boards and is supported under the DTI-led Technology Program.

Importantly, the system under development will combine very high performance with affordability through the utilization of novel transducer and system designs and the development of specialist integrated circuits. Initial applications for this system are expected to be cancer imaging, including the mapping of skin cancers, wound assessment and prevention, and superficial musculoskeletal imaging as well as specialist engineering inspections.

Paul Wilson, Managing Director of Longport International, said. “This project will build on expertise developed by Longport and the University of Manchester in high resolution ultrasound imaging and is seen as a logical evolution of Longport’s established medical imaging technology. The development is expected to bring the benefits of faster imaging as well as a broader range of image enhancement and processing techniques, including Doppler imaging, to Longport’s current customer groupings as well as expanding the markets that Longport can address.”

This project is part-funded by a Collaborative R&D grant under the Technology Programme.

Welcoming the new partnership, Science and Innovation Minister, Lord Sainsbury said, “This initiative provides a real opportunity to harness the world class expertise that we possess in the UK and direct it towards the task of wealth creation. By providing a focus for collaboration and delivery, this partnership should establish British industry as the world leader in this area and be an attractive proposition for investors.”

Related Article
See also related article on the Institute of Physics WEB site medicalphysicsweb under News Articles “Ultrasound Imaging High Resolution Hopes” use link below:

http://medicalphysicsweb.org/medphys/Articles/ViewArticle.do?channe l=industry&articleId=26402

Longport International, Ltd., is participating in a £1.1 million project supported by a Department of Trade & Industry grant to develop a high resolution phased array ultrasound imaging system. The system will be capable of imaging at centre frequencies greater than 25 MHz as well as at lower frequencies and is expected to exceed the imaging resolution of all current commercial multi-element ultrasound systems.

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