Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 4, 2019

(Date of earliest event reported)




(Exact name of registrant as specified in its charter)




Delaware   001-09585   04-2743260

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File Number)


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22 Cherry Hill Drive

Danvers, MA 01923

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(978) 646-1400

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Not Applicable

(Former Name or Former Address, if Changed Since Last Report)



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Item 8.01

Other Events.

Statement from Abiomed on RP Notification

Abiomed is committed to proactively sharing data to inform the medical community of best practices for use of the Impella RP® heart pump and to continue to improve outcomes for patients.

The Impella RP is the only device with FDA PMA approval for right side support. FDA studies demonstrate that proper use and timely implantation of Impella RP increases survival with the potential for recovery of the right ventricle [i] [ii]. The data below was published in December, 2018:

Impella RP PMA Cohort Study Results (N=60)



Survival Rates

PMA Subjects (RR + CAP + HDE PAS) – full cohort (N=60)

    Cohort A (N=31)

    Cohort B (N=29)


73% (44/60)

77% (24/31)

69% (20/29)

Journal of Heart and Lung Transplant, December 2018(37)

On January 31, 2019, Abiomed proactively sent physicians who use Impella RP post-approval study (PAS) data that provides additional evidence of the benefits of following proper protocols for placement of Impella RP. The data is summarized in the table below and demonstrates the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients for Impella RP.

The PMA cohort (n=60) had 73% survival and the PAS cohort (n=23) is currently at 17%. This PAS population has 70% (16/23) outside the recommended treatment protocol inclusion and exclusion criteria, and as a result survival rates are lower. These patients were critically ill and, in some cases, had been in profound shock for more than 48 hours. As such, these patients were statistically sicker and may not have been appropriate candidates to benefit from right side mechanical circulatory support.



Impella RP

Application (PMA)
(N=60 Patients)


Impella RP


(PMS) Report

(N=23 Patients)





     58.58±15.12(60)        65.61±13.72(23)        0.056  

Did the patient experience an in-hospital cardiac arrest prior to Impella implant

     0.00% (0/60)        56.52% (13/23)        <.001  

At the time of Impella implant did the patient receive CPR/ACLS

     0.05% (3/60)        30.43% (7/23)        <.001  

Was there evidence of hypoxicischemic brain injury prior to Impella implant

     0.00% (0/60)        14.29% (3/21)        0.016  

Was the patient supported with inotrope or vasopressors prior to Impella implant

     98.33% (59/60)        86.96% (20/23)        0.063  

If yes, Indicate total number of inotrope or vasopressors



     3.37±1.24(59)        4.38±1.56(13)        0.014  


     3.00        4.00     

Range (Min, Max)

     (1.00,6.00)        (2.00,8.00)     

Patients in shock >=48 hours

     0.00% (0/34)        26.09% (6/23)        <.001  

IABP used prior to Impella implant

     0.00% (0/60)        30.43% (7/23)        <.001  

Abiomed encourages all clinicians to review proper inclusion and exclusion criteria for Impella RP. To help physicians determine if Impella RP is right for their patients, Abiomed has created an FDA-approved checklist to guide treatment decisions and encourages the use of physician guidelines such as the National Cardiogenic Shock Initiative (https://www.henryford.com/cardiogenicshock/protocol) and the Shock Care Pathway Algorithms (http://www.onlinejacc.org/content/72/16/1972). The checklist is available at https://www.protectedpci.com/resources/. Right side failure remains a more difficult diagnosis than left side failure based on clinical experience and lower occurrence in clinical practice.

As a leader in post-market surveillance to improve patient outcomes, Abiomed tracks outcomes on nearly 100% of its Impella RP patients. The manufacturers of other technologies for right side support are cleared for less than 6 hours of support (ECMO, TandemLife®) and as a result, do not have regulatory responsibility to track and publically report a post approval study (PAS) on their patient outcomes. Abiomed will

continue to focus on improving clinical outcomes for both left and right ventricular failure by advancing innovation, identifying best practices and providing 24x7 on-site and on-call support to address the clinical crisis of cardiogenic shock in today’s healthcare system.

[i] Journal of Heart and Lung Transplant, December 2015(34)

[ii] Journal of Heart and Lung Transplant, December 2018(37)



Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


Abiomed, Inc.
By:   /s/ Todd A. Trapp

Todd A. Trapp

Vice President and Chief Financial Officer

Date: February 4, 2019