Abiomed has announced the launch of a new indication and Women's Initiative focused on heart recovery education and awareness. This Women's Initiative is in conjunction with the Company's expanded FDA approval for cardiogenic shock associated with cardiomyopathy, including peripartum and postpartum cardiomyopathy (PPCM). Clinical data collected in the cVAD Registry study included PPCM patients under the category of cardiomyopathy.
According to the Centers for Disease Control and Prevention (CDC), cardiovascular disease is the number one killer of women and causes 35 percent of deaths (approximately 430,000) in American women over the age of 201. Two causes of death as a result of cardiogenic shock, specific to the female population are PPCM and spontaneous coronary artery dissection (SCAD).
• PPCM occurs during pregnancy or after childbirth and is a leading cause of pregnancy-related deaths in the United States2. The disease is often difficult to diagnose, with a mortality rate of 10 percent, mainly driven by cardiogenic shock. This condition can lead to poor outcomes for the infant and carries a high risk of relapse in subsequent pregnancies4,5. Historic hospital protocols prioritized the life of the mother during the cardiogenic shock episode. With Impella support, patients can have minimally invasive therapy and avoid invasive surgeries and severe drug therapy.
• SCAD is a spontaneous tear in the coronary artery that may lead to cardiogenic shock or sudden death. SCAD is the number one cause of heart attacks in young women6 and the average age is 427. SCAD often occurs in patients who are active and healthy and 90 percent are women.
Impella® heart pumps offer the unique ability to stabilize the patient's hemodynamics and unload the heart, which allows the muscle to rest and potentially recover its native function. Heart recovery is the ideal option for a patient's quality of life and as documented in several clinical papers, has the ability to save costs for the healthcare system.
"The Impella platform provides a new treatment option for women suffering from cardiogenic shock caused by cardiomyopathy," said Cindy Grines, MD, Chair, Zucker School of Medicine at Hofstra/Northwell Health. "Additionally, unloading the heart so it can rest has the potential to improve outcomes specifically around heart recovery, for this young postpartum population. Education and patient awareness are also critical to properly diagnose and treat these patients."
"I am so grateful to be enjoying life without restrictions or limitations. Considering the nature of what happened, my story didn't have to end that way, but it did," said Lauri Evans, Impella patient. "And the more I learn, the more I understand what an important part Impella played."
"With our expanded indication, we can invest in education and awareness as we launch our Women's Initiative for Heart Recovery. Abiomed will establish a new physician and patient advisory board to make heart recovery the standard of care for women suffering from cardiogenic shock," said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. "We are so motivated and inspired to be part of the team that allows these young and otherwise healthy new mothers, like Laura, Kristie and Lauri, to return home to their families with their native heart and live the lives they were meant to have." – Medical Buyer Bureau