SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549
                                  FORM 10-KSB/A

                                 AMENDMENT NO. 1

      (Mark one)

|X|   Annual Report Under Section 13 or 15(d) of the Securities Exchange Act of
      1934

      For the fiscal year ended: December 31, 2000

|_|   Transition Report Under Section 13 or 15(d) of the Securities Exchange Act
      of 1934

      For the transition period from _________ TO ___________

Commission file number 0-28260

                               EP MedSystems, Inc.
                               -------------------
                 (Name of small business issuer in its charter)

            New Jersey                                   22-3212190
---------------------------------           ------------------------------------
  (State or Other Jurisdiction              (I.R.S. Employer Identification No.)
of Incorporation or Organization)

 100 Stierli Court, Mount Arlington, NJ                    07856
----------------------------------------                ----------
(Address of Principal Executive Offices)                (Zip Code)

                                 (973) 398-2800
                                 --------------
                (Issuer's Telephone Number, Including Area Code)

Securities registered under Section 12(b) of the Exchange Act: None

Securities registered under Section 12(g) of the Exchange Act: common stock, no
par value, $.001 stated value per share

Check whether the issuer: (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.

                                 |X| Yes |_| No

Check if disclosure of delinquent filers in response to Item 405 of Regulation
S-B is not contained in this form, and no disclosure will be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-KSB or any amendment to
this Form 10-KSB. |_|

The issuer's revenues for the fiscal year ended December 31, 2000 were
$9,760,000

The aggregate market value of the issuer's outstanding voting stock held by
non-affiliates on March 28, 2001, based on the closing sale price of its common
stock on the Nasdaq National Market on such date, was approximately $39,238,480.

As of March 28, 2001 there were outstanding 13,648,167 shares of the issuer's
common stock, no par value, stated value $.001 per share.

Transitional Small Business Disclosure Format (check one):

                                 |_| Yes |X| No
<PAGE>

               Explanatory Note to Amendment No. 1 to Form 10-KSB

This Form 10-KSB/A, Amendment No. 1 to Form 10-KSB (the "Amendment"), amends the
Annual Report on Form 10-KSB of EP MedSystems, Inc. for the period ended
December 31, 2000 to provide new disclosure under "Item 1. Description of
Business - General" relating to the status of the Pre-Market Approval
application of EP MedSystems for its ALERT (R) System product and to update
similar disclosures contained elsewhere in the Form 10-KSB (including in "Item
6. Management's Discussion and Analysis or Plan of Operation"), and to provide
an additional exhibit.

            Cautionary Statement Regarding Forward-Looking Statements

In addition to historical information, this Amendment to the Annual Report on
Form 10-KSB for EP MedSystems, Inc. (the "Company") contains forward-looking
statements relating to such matters as anticipated financial and operational
performance, business prospects, technological developments, results of clinical
trials, new products, research and development activities and similar matters.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements. We emphasize to you that a variety of factors could
cause the Company's actual results and experience to differ materially from the
anticipated results or other expectations expressed in the Company's
forward-looking statements. When we use the words or phrases "believe,"
"anticipate," "expect," "intend," "will likely result," "estimate," "project" or
similar expressions in this Amendment to the Annual Report on Form 10-KSB, we
intend to identify such forward-looking statements, but they are not the
exclusive means by which such statements are made. The forward-looking
statements are only expectations and/or predictions which are subject to risks
and uncertainties including the significant factors discussed in the Annual
Report on Form 10-KSB under "Risk Factors" and general economic, market or
business conditions, opportunities or lack of opportunities that may be
presented to the Company, competitive actions, changes in laws and regulations
and other matters discussed in the Form 10-KSB under the sections entitled "Item
1 - Business," "Item 3 - Legal Proceedings" and "Item 6 - Management's
Discussion and Analysis or Plan of Operation."

We caution readers to review the cautionary statements set forth in this
Amendment to the Annual Report on Form 10-KSB and in the Company's other reports
filed with the Securities and Exchange Commission and caution that other factors
may prove to be important in affecting the Company's business and results of
operations. We caution you not to place undue reliance on these forward-looking
statements, which speak only as of the date of this Amendment. The Company
undertakes no obligation to publicly revise these forward-looking statements to
reflect events or circumstances that arise after the date of this Amendment.

                                     Part I

Item l. Description of Business

General

As we have previously reported, the ALERT (R) System is a product developed by
the Company for internal cardioversion of atrial fibrillation which uses a
patented electrode catheter to deliver measured, variable, low-energy electrical
impulses directly to the inside of the heart in order to


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<PAGE>

convert atrial fibrillation to a normal heart rhythm. The ALERT (R) System is
not approved for sale in the United States but we have completed clinical trials
of over 150 patients and submitted our Pre Market Approval ("PMA") application
to the United States Food and Drug Administration (the "FDA") on October 2,
2000, which application was accepted for filing on November 21, 2000. On April
3, 2001, we announced that we had received notification from the FDA regarding
our PMA application. The notification, which is a routine step in the process of
obtaining pre market approval, outlines questions, comments and deficiencies in
the PMA application as filed and requests clarification and additional
information. The notification further indicates that our response and submission
of responsive documentation may extent the review period up to 180 days. We have
scheduled a meeting with the FDA and we anticipate preparation of a formal
response together with requested information to be submitted shortly after such
meeting. After receipt of such responsive submission, the FDA will determine the
completeness thereof and begin its final review. Due to the fact that review and
verification of our submitted data is required, approval to sell the ALERT (R)
System in the United States may take until the fourth quarter of 2001, if
approved at all. The Company has Class III Design Examination Certification from
the European notified body allowing us to label the ALERT (R) System with a CE
Mark, an international symbol of adherence to quality assurance standards,
design reviews and hazard analysis thereby allowing us to sell the ALERT (R)
System in the European Community.

                                    Part III

Item 13. Exhibits and Reports on Form 8-K

(a) Exhibits

The exhibits required to be filed as part of Annual Report on Form 10-KSB are
hereby amended to include the material contract set forth as Exhibit 10.16 on
the Index to Exhibits appearing on page E-1 hereof.


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<PAGE>

                                   SIGNATURES

In accordance with Section 13 or 15(d) of the Exchange Act, the Registrant
caused this report to be signed on its behalf by the undersigned, thereunder
duly authorized.

Date: April 30, 2001

                                          EP MedSystems, Inc.


                                          By: /s/ David A. Jenkins
                                              ------------------------------
                                          David A. Jenkins, Chairman of the
                                          Board, President and Chief
                                          Executive Officer

In accordance with the Exchange Act, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the
dates indicated.

Date: April 30, 2001                      /s/ David A. Jenkins
                                          ------------------------------------
                                          David A. Jenkins, Chairman of the
                                          Board, President and Chief
                                          Executive Officer
                                          (Principal Executive Officer)


                                          /s/ Joseph M. Turner
                                          ------------------------------------
                                          Joseph M. Turner, Chief Financial
                                          Officer and Secretary
                                          (Principal Accounting Officer)


                                          /s/ John E. Underwood
                                          ------------------------------------
                                          John E. Underwood, Director


                                          /s/ David W. Mortara
                                          ------------------------------------
                                          David W. Mortara, Director


                                          /s/ Darryl Fry
                                          ------------------------------------
                                          Darryl Fry, Director


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<PAGE>

Index to Exhibits

      Exhibit     Description
      Number

       10.16      Agreement, dated as of March 9, 1998, between ProCath
                  Corporation and Allan Willis


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