Clinical Data Highlights Advantages of Protected PCI to Enable Complete Revascularization and Improved Patient Quality of Life

DANVERS, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/heartrecovery?src=hash” target=”_blank”gt;#heartrecoverylt;/agt;–New research adds to 12 years of real-world data and FDA studies
demonstrating the use of Abiomed’s
(NASDAQ: ABMD) Impella
heart pumps
during high-risk PCI (Protected PCI) enables skilled
interventional cardiologists to achieve more complete revascularization,
improved ejection fraction and quality of life, and a reduction in
post-discharge adverse events.


A study published on April 9 in Journal
of Interventional Cardiology
examined complex high-risk patients
with multivessel disease who were considered unsuitable for surgery and
received an Impella-supported Protected PCI. The study found six months
after the Protected PCI, the number of patients with left ventricular
ejection fraction (LVEF) greater than or equal to 35% increased by 205%,
from 22% to 67% (n=79, p ≤ 0.001). The study also found more complete
revascularization was associated with significant LVEF improvement and
survival.

During a Protected PCI, the Impella heart pump is implanted minimally
invasively prior to an elective or urgent high-risk percutaneous
coronary intervention (PCI) to support the heart and provide hemodynamic
stability. This technology enables interventional cardiologists to treat
patients with severe coronary artery disease, the majority of whom have
been turned down for open heart surgery.

Impella is the only hemodynamic support device that is FDA PMA approved
as safe and effective for use during high-risk PCI. High-risk PCI is a
first-of-its-kind FDA indication and recognizes an appropriate patient
population.

The original FDA
PMA approval for Impella-supported high-risk PCI
in March 2015 was
based on the PROTECT
I FDA Trial
and PROTECT
II FDA Randomized Controlled Trial
, as well as clinical and
scientific supporting evidence from more than 215 publications, totaling
1,638 Impella patients. Further data was provided from 637 high-risk
patients enrolled in the U.S. Impella registry, now called the cVAD
Study
. The submission also incorporated a medical device reporting
analysis from approximately 14,000 Impella patients at the time. In
February 2018, Impella’s
FDA PMA was expanded
to include patients with mild or moderately
reduced ejection fraction. The data submitted to the FDA in support of
the expanded PMA indication included an analysis of 230 consecutive
patients with mild to moderately reduced ejection fraction from the cVAD
Study.

Abiomed is an industry
leader
in tracking real-world evidence and identifying and
validating best practices. Abiomed achieves this insight through FDA
post-approval studies (PAS) embedded in the IRB-approved, prospective
cVAD Study at select hospitals, and by collecting real-world data on
nearly 100% of U.S. Impella patients in the Impella Quality (IQ)
Database.

The IQ Database includes data on more than 36,000 Protected PCI patients
who were treated from April 2009 to March 2019. New data, announced
today, shows the mean and median LVEF remains below the ≤35% threshold
that is considered depressed, even after Impella received its expanded
FDA PMA to include patients with mild or moderately reduced ejection
fraction.

                 
Data Source   Date Range  

Number of
Patients1

 

Mean
Ejection
Fraction

 

Median
Ejection
Fraction

Protect I Pilot Trial and Protect II FDA Randomized Control Trial   2006 – 2012   245   25%   23%
IQ Database:

Original FDA PMA Indication – Depressed EF (≤35%)

  April 1, 2009 – February 14, 2018   25,214   25%   25%
IQ Database:

After Expanded FDA PMA Indication for Mild and Moderately
Depressed EF with Complex Anatomy and Comorbidities

(up to ~50% EF)

  February 15, 2018 – March 30, 2019   11,096   30%   30%

Note: On February 14, 2018, Impella’s FDA PMA indication was expanded to
include patients with mild and moderately depressed EF with complex
anatomy and comorbidities2.

Impella is the only FDA approved therapy for the estimated 121,000 U.S.
high-risk PCI patients3 who qualify each year for the FDA’s
definition of a high-risk PCI. Currently, Abiomed treats approximately
10% of the eligible population. Furthermore, a 2016 study by Doshi, et
al. that published in the Journal
of the American College of Cardiology
found, “it can be
estimated that every year more than 325,000 patients with new-onset HF
(heart failure) and CAD (coronary artery disease) might not be
adequately assessed for ischemic CAD4.”

The charts below show patient populations which include patients who are
appropriate for Protected PCI.

Impella enables experienced interventional cardiologists to achieve
complete revascularization and improved patient quality of life as
demonstrated in multiple studies and publications:

  • Journal
    of Cardiovascular Medicine
    , 2008
    Impella patients
    studied by Burzotta et al., had an improved LVEF at one year (from 31
    ± 7% to 41% ± 13%, p=0.02).
  • Journal
    of the American College of Cardiology
    , 2009
    – The PROTECT I
    trial found patients who had a Protected PCI with Impella had a 31%
    improvement in LVEF at 30 day follow up. (from 26 ± 6% to 34 ± 11%, p
    = 0.003).
  • Circulation,
    2012
    The PROTECT II Randomized Controlled Trial found
    Protected PCI with Impella led to a 58% improvement in NYHA class III
    and IV heart failure symptoms at 90 days (p<0.001). The trial also found, during follow-up after Protected PCI with Impella, patients had a 22% improvement in LVEF (p<0.001).
  • Catheterization
    Cardiovascular Interventions
    , 2012
    – Maini, et al., found a
    17% improvement in LVEF at follow up, after a Protected PCI with
    Impella (p<0.0001).
  • American
    Journal of Cardiology
    , 2014
    – An analysis of the PROTECT II
    Randomized Controlled Trial by Dangas, et al., found Impella use led
    to a 29% reduction in major adverse cardiac and cerebrovascular events
    (MACCE) at 90 days, compared to the use of the intra-aortic balloon
    pump (IABP) (p=0.042).
  • Journal
    of Interventional Cardiology
    , 2015
    – Kovacic, et al., found
    Impella maintains patient hemodynamics, allowing for more complete
    revascularization and improved outcomes. For example, when three
    vessels were treated, the procedural decrease in arterial pressure
    from baseline was -18.8% for IABP, compared to -7.6% for Impella
    (p=0.026).
  • The
    American Journal of Cardiology
    , 2018
    – Alaswad, et al.,
    compared patients with LVEF > 35% to patients with LVEF ≤ 35% and
    found, despite high-risk features, MACCE rates were favorable, with no
    differences between the two groups (3.48% vs 4.54%; p=0.574).
  • Journal
    of Interventional Cardiolog
    y, 2019
    – Burzotta, et al., found
    Protected PCI with Impella is associated with LVEF improvement in
    complex high-risk patients. The authors also found more complete
    revascularization is associated with increased LVEF and survival.

Acute kidney injury (AKI) is lower in Impella patients undergoing
high-risk PCI:

  • Circulation,
    2012
    The PROTECT II Randomized Controlled Trial found,
    despite higher levels of contrast in the Impella arm, acute renal
    dysfunction was lower in the Impella arm at 30 days and 90 days
    (p=0.792 and p=0.776, respectively).
  • Circulation
    Research
    , 2017
    – Flaherty, et al., identified a six-fold
    reduction in AKI requiring dialysis when Impella support was used,
    compared to without Impella support (p=0.031).
  • Journal
    of the American College of Cardiology
    , 2019
    – Flaherty et al.,
    found, compared to a predicted rate of 22%, only 7% of
    Impella-supported patients developed AKI at 72 hours, representing a
    70% lower AKI risk (p<0.0001).

Impella is cost effective:

Patients who have benefited from Protected PCI with Impella include Mongin
Smyly
, whose constant fatigue and weakness left him feeling
hopeless. That’s when he was identified as an appropriate candidate for
a Protected PCI with Impella. Following his procedure, Mr. Smyly
experienced an improved quality of life and was able to return to work.
He said, “Following the Protected PCI procedure, I felt better than I
had in a long time. Today, I am back to enjoying life with my wife and
family and I am beyond grateful.”

“The scientific evidence clearly demonstrates the advantages of
conducting a Protected PCI in patients who have compromised
hemodynamics, complex coronary artery disease and comorbidities. In the
past, these patients would have had minimal to no other treatment
options,” said Ayaz Rahman, MD, the interventional cardiologist at
Parkwest Medical Center who treated Mr. Smyly. “Protected PCI with
Impella allows for more complete revascularization and better long-term
outcomes. It also improves the patient’s quality of life and reduces
readmissions.”

ABOUT IMPELLA HEART PUMPS

The Impella 2.5 and Impella CP devices are FDA 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 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. 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.protectedpci.com.

Impella is the most studied mechanical circulatory support device in the
history of the FDA and has exclusive PMA approvals for high-risk PCI, as
a therapy to allow for native heart recovery after cardiogenic shock
derived from AMI or cardiomyopathy, and right ventricular heart failure.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella
LD, Impella CP, Impella RP, Impella Connect, and Recovering hearts.
Saving lives. are registered trademarks of ABIOMED, Inc. in the U.S. and
in certain foreign countries.

ABOUT ABIOMED

Based in Danvers, Massachusetts, 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.

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.

1Patients with ejection fraction values
2 On
February 14, 2018, Impella’s FDA PMA indication was expanded to read:
The Impella 2.5®, Impella CP® and Impella CP®
with SmartAssist® Systems are temporary (≤ 6 hours)
ventricular support devices indicated for use during high-risk
percutaneous coronary interventions (PCI) performed in elective or
urgent, hemodynamically stable patients with severe coronary artery
disease, when a heart team, including a cardiac surgeon, has determined
high-risk PCI is the appropriate therapeutic option. Use of the Impella
2.5, Impella CP, and Impella CP with SmartAssist Systems in these
patients may prevent hemodynamic instability, which can result from
repeat episodes of reversible myocardial ischemia that occur during
planned temporary coronary occlusions and may reduce peri- and
post-procedural adverse events.
3 American Heart
Association, Heart Disease & Stroke Statistics, 2015 Update; Gheorghiade
et al. Circulation; Braunwald, et al. JACC; Dehmer, et al. JACC;
Peterson NEJM 2010; Farmer et al. JACC Cardiovasc Imaging.
2014;7(7):690-700.
4 Doshi D, et al. J Am Coll Cardiol.
2016;68(5):450-458.

Contacts

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

Author: dmnnewswire