Document:

<PAGE>   1

                                                                 EXHIBIT 10.34.2

                                  AMENDMENT II

     Amendment to the Facility Set-Up and Contract Manufacturing Agreement
                             and License Agreement

                                    between

                         RADIANCE MEDICAL SYSTEMS INC.
                                hereafter "RMS"
                   located at 13700 Alton Parkway, Suite 160,
                          in Irvine, California, 92618

                                      and

                BEBIG ISOTOPENTECHNIK AND UMWELTDIAGNOSTIK GmbH,
                               hereafter "BEBIG"
                       located at Robert-Rossie-Str. 10,
                            in 13125 Berlin, Germany

BACKGROUND

RMS and BEBIG have signed a FACILITY SET-UP AND CONTRACT MANUFACTURING
AGREEMENT including the ADDENDUM TO FACILITY SET-UP AND CONTRACT MANUFACTURING
AGREEMENT and a LICENSE AGREEMENT (collectively referred to as "the
Agreements"), both amended by the AMENDMENT TO THE FACILITY SET-UP AND CONTRACT
MANUFACTURING AGREEMENT AND THE LICENSE AGREEMENT (referred to as "Amendment
1").

RMS desires to extend the future capacity of production determined by the
FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT and therefore appoints
BEBIG to install additional two new Production Lines at the Facility.

In the light of the above, both parties desire to amend the existing Agreements
and the Amendment 1 as follows:

1. PROVISION OF ADDITIONAL FACULTY SPACE

BEBIG will prepare and make available another 65 square meters (referred to as
the "New Facility") of laboratory space next to the existing laboratory in its
building at Robert-Rossie-Str. 10, 13125 Berlin, Germany. The New Facility
shall be suitable for handling and production of radioactive balloon catheters.
In return RMS will pay to BEBIG an additional one-time facility fee of $US
50,000 (referred to as "Additional Facility Fee").

2. EXTENSION OF RENTAL TERM

The extension fee in 1(c) FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT
will be increased to $US 75,000, payable by Radiance upon the beginning of
each new Rental Term. This increase will not apply for the first extension of
the Rental Term.

                                  page 1 of 3

<PAGE>   2

3. ADDITIONAL EQUIPMENT REQUIREMENTS AND VALIDATION

BEBIG will establish two new assembly platform containment cells according to
the provisions of the FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT
including the ADDENDUM TO FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT.
After installation of the equipment Bebig will carry out the Process Validation
after giving written notice to RMS. All material costs and third party expenses
during the validation process shall be borne by RMS.

Bebig will purchase the Components for the assembly platforms from RMS for a
price of US$ 450,000, payable upon receipt of shipment.

4. COMPENSATIONS

RMS will reimburse BEBIG or its affiliates for the new production requirements
with an investment contribution of US$ 585,000 excluding taxes if any. This
amount includes the costs for fabrication and validation of the two additional
containment cells.

Radiance will reimburse BEBIG for its additional activities agreed by this
Amendment II with payments are due at the following dates:

<TABLE>
<CAPTION>
--------------------------------------------------------------------------------
MILESTONE                                     TARGET DATE             AMOUNT
--------------------------------------------------------------------------------
<S>                                           <C>                     <C>
Upon Execution of the Amendment II
"Additional Facility Fee" (see section 1)     Effective Date         50,000 US$
--------------------------------------------------------------------------------
Installation of the Containment cells
(containment cells ready for set-up           March 2001            377,000 US$
of assembly platforms)
--------------------------------------------------------------------------------
Assembly platforms readiness
(cold and hot qualifications done)            April 2001            208,000 US$
--------------------------------------------------------------------------------
                                                       TOTAL:       635,000 US$
</TABLE>

5. LICENSE FEE OFFSETS

Both parties agree, that amounts to be paid by RMS according to the provisions
of this Amendment II are not subject to offsetting of the license fee or
royalties as provided by sec. 4 LICENSE AGREEMENT.

6. MAINTENANCE COSTS

Both parties agree, that RMS covers all maintenance cost of the equipment
delivered by RMS during the rental term. Maintenance cost on the before
mentioned equipment is billed back to RMS at cost.

                                  Page 2 of 3

<PAGE>   3

7. MISCELLANEOUS

Except as specifically modified by this Amendment II, all terms and conditions
of the Agreements and Amendment I shall continue unchanged.

Date:  2/12/01                                   Date:  2/02/01

/s/ DR. ANDRE HESS                               /s/ JOSEPH A. BISHOP
---------------------------                      ------------------------------
BEBIG GmbH                                       Radiance Medical Systems, Inc.

                                  Page 3 of 3<PAGE>   1
                                                                 EXHIBIT 10.34.3

                                 AMENDMENT III

   Amendment to the Facility Set-Up and Contract Manufacturing Agreement and
                               License Agreement

                                    between

                         RADIANCE MEDICAL SYSTEMS INC.
                                hereafter "RMS"
                   located at 13700 Alton Parkway, Suite 180,
                          in Irvine, California, 92618

                                      and

                BEBIG ISOTOPENTECHNIK AND UMWELTDIAGNOSTIK GmbH,
                               hereafter "BEBIG"
                       located at Robert-Rossie-Str. 10,
                            in 13125 Berlin, Germany

BACKGROUND TO AMENDMENT

RMS and BEBIG have signed a FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT
including the ADDENDUM TO FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT
and a LICENSE AGREEMENT (collectively referred to as "the Agreements"), both
amended by the AMENDMENT TO THE FACILITY SET-UP AND CONTRACT MANUFACTURING
AGREEMENT AND THE LICENSE AGREEMENT (referred to as "Amendment 1").

RMS wants BEBIG to provide additional services for the radioactive balloon
catheter. BEBIG intends to install and perform these services. Therefore, both
parties desire to amend the Agreements and Amendment 1.

On these premises the parties agree as follows:

1.  CONTRACT MANUFACTURING, PRODUCTION CAPACITY AND SERVICES

    BEBIG will provide additional services and materials to RMS for the
    radioactive balloon catheter. All services are described in detail in
    Appendix A. All costs related to the materials and services described in
    Appendix A shall be covered by BEBIG.

    Bebig will provide production capacity according to the following schedule:

    <TABLE>
    <CAPTION>
                                  PRODUCTION CAPACITY
    TIME PERIOD                       PER MONTH
    -----------                   -------------------
    <S>                           <C>
       April - June 2001                   40
     July - September 2001                124
    October - December 2001               275
     January - March 2002                 800
    </TABLE>

    BEBIG will receive from RMS, 3 months prior to each quarter, an updated
    build plan forecast on a rolling basis giving the production capacity
    needed. All exceeding amount with respect to above mentioned schedule will
    be considered on a best effort basis.

<PAGE>   2
2.   COMPENSATIONS

a)   RETAINER

     RMS and BEBIG agree that as a compensation for maintaining the production
     of radioactive balloon catheters, RMS shall pay a fixed price of US $20,000
     per month as a retainer. RMS shall pay such retainer for each month after
     Delivery of First Product, but not later than April 2001. Payment shall be
     due on the 5th of each calendar month.

b)   PRICE PER CATHETER

     i)   RMS will pay to BEBIG the following prices for each unit of product
          depending on the number of ordered and manufactured products per
          month:

<TABLE>
<CAPTION>
                ORDERED AND MANUFACTURED                PRICE PER CATHETER
                  CATHETERS PER MONTH                          US$
          ----------------------------------------------------------------
<S>                                                     <C>
                           1-40                                380
          ----------------------------------------------------------------
          Each additional unit to maximum of 120               375
          ----------------------------------------------------------------
          Each additional unit to maximum of 280               350
          ----------------------------------------------------------------
          Each additional unit to maximum of 800               306
          ----------------------------------------------------------------
</TABLE>

     ii)  The price includes the process fee of US$ 80 from sec 6.d of the
          FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT and shall be due
          within 7 days after the end of the month in which the product was
          manufactured. Prices quoted without taxes if any and Ex Works Berlin.

     iii) In the event of an increase in the production cost, BEBIG may add to
          the above mentioned prices possible increases in material and
          production costs provided these increases exceed 10% in each contract
          year. BEBIG shall provide RMS two months in advance with evidence of
          such price increases and the impact of it on the cost of the product,
          which RMS will not unreasonable refuse.

3.   FORECAST AND BINDING ORDER

     a)   BEBIG will receive from RMS, 4 weeks prior to the date of
          manufacture, a non-binding supply requirement forecast on a rolling
          basis giving the amount of catheters needed.

     b)   BEBIG will receive from RMS, 2 weeks prior to the date of
          manufacture, a firm order. The firm order shall not exceed the
          production capacity as indicated in sec. 1 and the forecast. All
          exceeding amount will be considered on a best effort basis.

4.   LICENSE FEE OFFSETS

     Payments of sec 2, in this Amendment III shall not be subject to
     offsetting of the license fee or royalties as provided by sec 4, License
     Agreement.

5.   MISCELLANEOUS

     a)   The terms of this Amendment III shall be for a period of one (1) year
          from 1 April 2001. This Amendment III will automatically be extended
          for one (1) year on the basis of the numbers of the last quarter of
          the contract year unless a written cancellation is given by either
          party at least two (2) months in advance of a renewal date.

                                       2
<PAGE>   3
b)   Except as specifically modified by this amendment, all terms and conditions
     of the Agreements and conditions shall continue unchanged.

Date:  2/12/01                                    Date:  2/02/01

/s/ DR. ANDRE HESS                                /s/ JOSEPH A. BISHOP
---------------------------                       ------------------------------
BEBIG GmbH                                        Radiance Medical Systems, Inc.

                                       3

<PAGE>   4

                                   APPENDIX A

SERVICES PROVIDED BY BEBIG

BEBIG will provide the following services for RMS:

1. RAW MATERIAL SUPPLY
   - Provision of a sufficient stock of P-32 at its facility
   - Procurement of auxiliary material for the chemical process
   This does not include the foils themselves.

2. PACKAGING
   Provision of packaging materials including:
   - pouch
   - white chipboard box
   - outer shipping carton
   - insert for shipping carton
   - filler
   This does not include tray and lids of the catheter package.

3. STERILIZATION
   Gamma sterilization of 25 kGy will be performed. The costs for the
   sterilization and for the transportation of the goods from our facilities to
   the sterilizer and back are included for the following volume:

   Up to 50 catheters/week       1 sterilization/week
   51 to 100 catheters/week      2 sterilizations/week
   101 to 200 catheters/week     3 sterilizations/week

   Requests for additional sterilizations per week will be arranged, but
   additional costs will be done by RMS. Costs for any additional or
   re-validations of the sterilization process are not included.

4. LABELING
   Compiling and printing all labels.
   The costs for the label material are not included.

5. QUALITY CONTROL
   - QA according to RMS requirements
   - quarterly environmental monitoring
   - radio safety control
   This does not include any costs for additional or re-validations.

6. LOGISTICS SUPPORT
   - handling and storage of all deliveries
   - arranging of all shipments
   - maintaining a shipment tracking system

7. COMPLAINT HANDLING
   - providing information of the particular product
   - handling returned products
   - testing returned products and generating a report
   - disposal of returned products

8. WASTE DISPOSAL
   Costs for handling and disposal of residual raw material and other
   radioactive waste is included.

                                       4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00022-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00022-of-00352.parquet"}]]