Abiomed’s (NASDAQ:ABMD) Impella platform is being featured
today at a Washington, D.C., event showcasing innovations in
medical technology that improve healthcare for women. Abiomed’s
participation supports its Women’s Initiative for Heart Recovery,
which provides education and raises awareness of women’s
cardiovascular diseases and the opportunity for heart recovery. The
event, hosted by AdvaMed, brings together members of Congress and
their staff at the Rayburn House Office Building on Capitol
Hill.
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the full release here:
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The Impella heart pump helped Iman
Dorty’s heart recover so she could return home to her family.
(Photo: Abiomed, Inc.)
One young woman who benefited from heart recovery with Impella
support is Iman Dorty, who is speaking at today’s event. When she
was 28 and six months into her pregnancy, Iman had a seizure and
was rushed to the hospital, where physicians determined an
infection was attacking Iman’s heart. The medical team induced
labor hoping that Iman’s heart would regain its strength without
the demands of pregnancy, but Iman’s heart continued to
deteriorate. Physicians then implanted the Impella 5.0 to support
the pumping function of her heart. After five days, Impella allowed
Iman’s heart muscle to rest and recover. The pump was removed, and
Iman returned home to her new baby, Liam. Next year, she will
celebrate the 10th anniversary of her heart recovery, demonstrating
the long-term benefits of heart recovery. When compared to the
long-term results of heart transplants, heart recovery is often the
ideal option for patients and more cost-effective for the
healthcare system1,2,3,4.
“Because of the dedication of the medical staff who treated me
and the support of the Impella heart pump, my heart was able to
recover,” said Dorty. “Over the last nine years, I’ve had the great
fortune of sharing my story to advocate for heart recovery and
educate women about the symptoms of heart disease. But most
importantly, I’ve been able to be a mom and raise my son,
Liam.”
Cardiovascular disease is the number one killer of women and
causes approximately 432,000 deaths annually in American women over
the age of 205. Impella therapy can help women who go into
cardiogenic shock after developing two types of female-specific
cardiovascular diseases: peripartum cardiomyopathy (PPCM) and
spontaneous coronary artery dissection (SCAD).
- PPCM is a disease of the heart muscle
that occurs during pregnancy or after childbirth and is a leading
cause of pregnancy-related deaths in the United States6. The
disease is often difficult to diagnose as symptoms mimic those of
pregnancy. After delivering her daughter Amelia, Jessica Grib
developed PPCM and went into cardiogenic shock. Physicians
implanted the Impella CP, which allowed her heart to rest and
ultimately recover. Today, Jessica’s heart function is normal and
she’s back to her busy routine raising her two children with her
husband, Kevin.
- SCAD is a spontaneous tear in the
coronary artery that may lead to cardiogenic shock or sudden death.
SCAD often occurs in patients who are active and healthy, and 90%
of SCAD patients are women. SCAD is the number one cause of heart
attacks in young women7. The average age is 424. Jara Herron,
mother of seven, developed SCAD and went into cardiogenic shock ten
days after delivering her daughter. Physicians placed the Impella
2.5 to perfuse her end organs, support her heart and allow it to
rest and recover. She returned home to her husband and children and
is back to her life as a mom and business-owner.
"Iman, Jessica, Jara, and the thousands of other women who have
been treated with Impella, inspire us to make heart recovery the
standard of care for women suffering from cardiogenic shock," said
Michael R. Minogue, Chairman, President and Chief Executive Officer
of Abiomed. “We are committed to enabling heart recovery for these
sisters, mothers and daughters so they can return home to enjoy a
normal quality of life with their families and friends.”
Impella is the most studied mechanical circulatory support
device in the history of the FDA and the FDA has concluded, based
on clinical studies and a randomized controlled trial, that Impella
is safe and effective. Impella is included in 8 clinical guidelines
and more than 550 peer-reviewed clinical publications. The Impella
Quality (IQ) Database includes real-world data from more than
90,000 Impella cases from more than 1,100 U.S. centers. The cVAD
Study, which is an IRB approved, prospective study includes more
than 5,000 patients.
As a result, Impella has the highest level of U.S. regulatory
approval and is the only FDA-approved, on-label technology for
high-risk PCI and AMI cardiogenic shock, including cardiogenic
shock derived from cardiomyopathy and right ventricular heart
failure.
Learn more about women who have recovered from PPCM and SCAD
after hemodynamic support from Impella at
www.abiomed.com/patients.
1. Maini B, Gregory D, Scotti DJ, Buyantseva L. Percutaneous
Cardiac Assist Devices Compared with Surgical Hemodynamic Support
Alternatives: Cost-Effectiveness in the Emergent Setting. Catheter
Cardiovasc Interv. 2014 May 1;83(6):E183-92
2. Cheung A, Danter M, Gregory D. TCT-385 Comparative Economic
Outcomes in Cardiogenic Shock Patients Managed with the Minimally
Invasive Impella or Extracorporeal Life Support. J Am Coll Cardiol.
2012;60(17_S)
3. Gregory D, Scotti DJ, de Lissovoy G, Palacios I, Dixon, Maini
B, O'Neill W. A value-based Analysis of Hemodynamic Support
Strategies for High-Risk Heart Failure Patients Undergoing a
Percutaneous Coronary Intervention. Am Health Drug Benefits. 2013
Mar;6(2):88-99
4. Jaramillo, N., et al. Characteristics of Patients With
Survival Longer Than 20 Years Following Heart Transplantation.
Revisita Espanola de Cardiologicia.
http://www.revespcardiol.org/en/characteristics-of-patients-with-survival/articulo/90229509/
5. Heart Disease Statistics. CardioSmart, American College of
Cardiology: https://www.cardiosmart.org/Heart-Basics/CVD-Stats
6. Centers for Disease Control and Prevention, Trends in
Pregnancy-Related Deaths:
https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.html
7. Grosseto D, Santarelli A, Carigi S, Baldazzi F, Franco N,
Santoro D et al. Incidence of Spontaneous Coronary Artery
Dissection in All Comers Patients Referred for Acute Coronary
Syndrome [abstract 194] Eur Heart J: Acute Cardiovasc Care.
2012;1(1 Suppl):61
8. Hayes SN. Spontaneous Coronary Artery Dissection (SCAD): New
Insights into This Not-So-Rare Condition. Texas Heart Institute
Journal. 2014;41(3):295-298. doi:10.14503/THIJ-14-4089
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA
approved to treat certain advanced heart failure patients
undergoing elective and urgent percutaneous coronary interventions
(PCI) such as stenting or balloon angioplasty, to re-open blocked
coronary arteries. The Impella 2.5, Impella CP, Impella CP with
SmartAssist™, Impella 5.0® and Impella LD® are U.S. FDA approved
heart pumps used to treat heart attack or cardiomyopathy patients
in cardiogenic shock, and have the unique ability to enable native
heart recovery, allowing patients to return home with their own
heart. The Impella RP® is U.S. FDA approved to treat right heart
failure or decompensation following left ventricular assist device
implantation, myocardial infarction, heart transplant, or
open-heart surgery.
In Europe, the Impella 2.5, Impella CP and Impella CP with
SmartAssist are CE marked for treatment of high-risk PCI and AMI
cardiogenic shock patients for up to 5 days. Impella 5.0 and
Impella LD are CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 10 days. The Impella 5.5™
heart pump is CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 30 days. The Impella RP is
CE marked to treat right heart failure or decompensation following
left ventricular assist device implantation, myocardial infarction,
heart transplant, open-heart surgery, or refractory ventricular
arrhythmia.
To learn more about the Impella platform of heart pumps,
including their approved indications and important safety and risk
information associated with the use of the devices, please visit
www.impella.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading
provider of medical devices that provide circulatory support. Our
products are designed to enable the heart to rest by improving
blood flow and/or performing the pumping of the heart. For
additional information, please visit www.abiomed.com.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella
CP, Impella RP, and Impella Connect are registered trademarks of
Abiomed, Inc., and are registered in the U.S. and certain foreign
countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and
SmartAssist are pending trademarks of Abiomed, Inc.
FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including
statements regarding development of Abiomed's existing and new
products, the company's progress toward commercial growth, and
future opportunities and expected regulatory approvals. The
company's actual results may differ materially from those
anticipated in these forward-looking statements based upon a number
of factors, including uncertainties associated with development,
testing and related regulatory approvals, including the potential
for future losses, complex manufacturing, high quality
requirements, dependence on limited sources of supply, competition,
technological change, government regulation, litigation matters,
future capital needs and uncertainty of additional financing, and
other risks and challenges detailed in the company's filings with
the Securities and Exchange Commission, including the most recently
filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
Readers are cautioned not to place undue reliance on any
forward-looking statements, which speak only as of the date of this
release. The company undertakes no obligation to publicly release
the results of any revisions to these forward-looking statements
that may be made to reflect events or circumstances that occur
after the date of this release or to reflect the occurrence of
unanticipated events.
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version on businesswire.com: https://www.businesswire.com/news/home/20190613005521/en/
**For further information please contact:Tom
LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.comIngrid Goldberg
WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
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