Impella Featured as an Innovative Technology at U.S. Capitol Event Showcasing Improvements to Women’s Health
DANVERS, Mass.–(BUSINESS WIRE)–#heartrecovery–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.
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.
Contacts
**For further information please contact:
Tom Langford
Director,
Communications and Public Relations
978-882-8408
tlangford@abiomed.com
Ingrid
Goldberg Ward
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com
