Highlights:
• 6 Year, 596 patient study undertaken in Nashville Breast Center in Nashville, Tennessee
• The largest L-Dex study published to-date
• 596 patients using L-Dex demonstrates prospective monitoring and intervention result in extremely low rates (3%) of chronic, clinically significant breast cancer related lymphoedema
• Full study results to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago 2-6 June 2017
• Strong independent third party demonstration of the benefit of L-Dex, reinforcing recent guidelines that support prospective screening and intervention for breast cancer related lymphoedema (BCRL)
• ASCO is expecting to draw over 30,000 oncology professionals from the US and around the world
Brisbane, Australia, and Carlsbad, Calif. - ImpediMed Limited (ASX: IPD) a global provider of medical technology to measure, monitor and manage fluid status and body composition, is pleased to announce that it has been advised of very positive data from an independent 6-year, 596 patient study that will be presented at the upcoming ASCO’s Annual Meeting to be held in Chicago, 2-6 June 2017.
The study, which was a retrospective analysis by Pat Whitworth, MD of Nashville, followed breast cancer patients at risk for the development of lymphoedema. The study, conducted from April 2010 to Nov 2016, used L-Dex in a prospective surveillance model to identify patients with early/subclinical indications for the development of BCRL.
Patients who developed an elevated L-Dex score (>10) relative to their pre-surgical baseline score, were prescribed an over the counter compression sleeve to use for four weeks. At last follow-up, only 18 of the 596 patients (3%) had unresolved clinically significant BCRL requiring Complete Decongestive Physiotherapy (CDP), a surrogate for the development of clinically significant, chronic BCRL.
These results demonstrate clinical BCRL rates that are substantially lower than the 7%-36% rates (and as high as up to 50% rate in patients receiving aggressive treatment for breast cancer) generally reported in contemporary studies where patients were not prospectively surveilled for the development of BCRL.
“Though guidelines encourage prospective screening and intervention for BCRL, the methods previously available could not detect tissue changes at a preventable stage,” remarked Pat Whitworth, MD, the author of the study.
“In the past, it was simply bad news for the patient, "You have lymphoedema; now let's try to manage it as best we can.’’ For the first time, this technology makes early detection, simple intervention and prevention of clinical BCRL possible. It is the responsibility of the entire breast care community to inform women about this advancement.”
For further information, contact:
Richard Carreon, ImpediMed Managing Director & CEO
Morten Vigeland, ImpediMed CFO
T: +1 (760) 585-2100
Media and Investor Contacts:
In Australia:
Kyahn Williamson, WE Buchan
T: +61 3 9866 4722
E: kwilliamson@buchanwe.com.au
About ImpediMed
Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif. and Bloomington, Minn., ImpediMed is the world leader in the development and distribution of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status in patients. ImpediMed has the first medical device with FDA clearance in the U.S. to aid healthcare professionals to clinically assess unilateral lymphoedema of the arm and leg in women and the leg in men. For more information, visit www.impedimed.com.
• 6 Year, 596 patient study undertaken in Nashville Breast Center in Nashville, Tennessee
• The largest L-Dex study published to-date
• 596 patients using L-Dex demonstrates prospective monitoring and intervention result in extremely low rates (3%) of chronic, clinically significant breast cancer related lymphoedema
• Full study results to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago 2-6 June 2017
• Strong independent third party demonstration of the benefit of L-Dex, reinforcing recent guidelines that support prospective screening and intervention for breast cancer related lymphoedema (BCRL)
• ASCO is expecting to draw over 30,000 oncology professionals from the US and around the world
Brisbane, Australia, and Carlsbad, Calif. - ImpediMed Limited (ASX: IPD) a global provider of medical technology to measure, monitor and manage fluid status and body composition, is pleased to announce that it has been advised of very positive data from an independent 6-year, 596 patient study that will be presented at the upcoming ASCO’s Annual Meeting to be held in Chicago, 2-6 June 2017.
The study, which was a retrospective analysis by Pat Whitworth, MD of Nashville, followed breast cancer patients at risk for the development of lymphoedema. The study, conducted from April 2010 to Nov 2016, used L-Dex in a prospective surveillance model to identify patients with early/subclinical indications for the development of BCRL.
Patients who developed an elevated L-Dex score (>10) relative to their pre-surgical baseline score, were prescribed an over the counter compression sleeve to use for four weeks. At last follow-up, only 18 of the 596 patients (3%) had unresolved clinically significant BCRL requiring Complete Decongestive Physiotherapy (CDP), a surrogate for the development of clinically significant, chronic BCRL.
These results demonstrate clinical BCRL rates that are substantially lower than the 7%-36% rates (and as high as up to 50% rate in patients receiving aggressive treatment for breast cancer) generally reported in contemporary studies where patients were not prospectively surveilled for the development of BCRL.
“Though guidelines encourage prospective screening and intervention for BCRL, the methods previously available could not detect tissue changes at a preventable stage,” remarked Pat Whitworth, MD, the author of the study.
“In the past, it was simply bad news for the patient, "You have lymphoedema; now let's try to manage it as best we can.’’ For the first time, this technology makes early detection, simple intervention and prevention of clinical BCRL possible. It is the responsibility of the entire breast care community to inform women about this advancement.”
For further information, contact:
Richard Carreon, ImpediMed Managing Director & CEO
Morten Vigeland, ImpediMed CFO
T: +1 (760) 585-2100
Media and Investor Contacts:
In Australia:
Kyahn Williamson, WE Buchan
T: +61 3 9866 4722
E: kwilliamson@buchanwe.com.au
About ImpediMed
Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif. and Bloomington, Minn., ImpediMed is the world leader in the development and distribution of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status in patients. ImpediMed has the first medical device with FDA clearance in the U.S. to aid healthcare professionals to clinically assess unilateral lymphoedema of the arm and leg in women and the leg in men. For more information, visit www.impedimed.com.
