77413 RA KRE Department for Cancer Treatment Cell Prosthesing Equipment

Justification for Direct Award – Equipment for Gradient Separation of Pancreatic Tissue This procurement concerns the acquisition of new equipment for gradient separation of islet cells from pancreatic tissue at the Section for Cell Therapy (SfC), Oslo University Hospital (OUS). The contracting authority intends to procure two (2) units of …

CPV: 33000000 Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet, 38000000 Laboratoriolaitteet, optiset ja tarkkuuslaitteet (lukuun ottamatta silmälaseja)
Teloituspaikka:
77413 RA KRE Department for Cancer Treatment Cell Prosthesing Equipment
Myöntävä elin:
Oslo Universitetssykehus HF (hovedenhet)
Myöntämisnumero:
77413

1. Buyer

1.1 Buyer

Official name : Oslo Universitetssykehus HF (hovedenhet)

2. Procedure

2.1 Procedure

Title : 77413 RA KRE Department for Cancer Treatment Cell Prosthesing Equipment
Description : Justification for Direct Award – Equipment for Gradient Separation of Pancreatic Tissue This procurement concerns the acquisition of new equipment for gradient separation of islet cells from pancreatic tissue at the Section for Cell Therapy (SfC), Oslo University Hospital (OUS). The contracting authority intends to procure two (2) units of Cellsaver Xtra from LivaNova AS. The estimated annual usage is 15 procedures. Please refer to the attached detailed justification. In light of the technical requirements, the need for methodological validation, and regulatory considerations, LivaNova AS is assessed to be the only supplier capable of fulfilling the requirements. The conditions for applying the negotiated procedure without prior publication, pursuant to §13-4 (2) of the Norwegian Public Procurement Regulations (FOA), are therefore considered fulfilled. Any objections must be submitted through the communication module in Mercell within 10 days of the publication of this notice.
Procedure identifier : 036efd05-9478-4b6f-9d7d-f56817f58988
Internal identifier : 77413
Type of procedure : Negotiated without prior call for competition

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products
Additional classification ( cpv ): 38000000 Laboratory, optical and precision equipments (excl. glasses)

2.1.2 Place of performance

Town : Oslo
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway

2.1.4 General information

Legal basis :
Directive 2014/24/EU
Anskaffelsesforskriften - See the attached justification. Given the technical requirements, methodical validation and regulatory considerations, LivaNova AS is considered as the sole supplier who can meet our needs, in accordance with the terms in PPR § 13-4 (2).

5. Lot

5.1 Lot technical ID : LOT-0000

Title : 77413 RA KRE Department for Cancer Treatment Cell Prosthesing Equipment
Description : Justification for Direct Award – Equipment for Gradient Separation of Pancreatic Tissue This procurement concerns the acquisition of new equipment for gradient separation of islet cells from pancreatic tissue at the Section for Cell Therapy (SfC), Oslo University Hospital (OUS). The contracting authority intends to procure two (2) units of Cellsaver Xtra from LivaNova AS. The estimated annual usage is 15 procedures. Please refer to the attached detailed justification. In light of the technical requirements, the need for methodological validation, and regulatory considerations, LivaNova AS is assessed to be the only supplier capable of fulfilling the requirements. The conditions for applying the negotiated procedure without prior publication, pursuant to §13-4 (2) of the Norwegian Public Procurement Regulations (FOA), are therefore considered fulfilled. Any objections must be submitted through the communication module in Mercell within 10 days of the publication of this notice.
Internal identifier : 77413

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products
Additional classification ( cpv ): 38000000 Laboratory, optical and precision equipments (excl. glasses)
Options :
Description of the options : 0

5.1.2 Place of performance

Town : Oslo
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Additional information :

5.1.3 Estimated duration

Start date : 03/10/2025
Duration end date : 03/10/2035

5.1.4 Renewal

Maximum renewals : 0

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Oslo tingrett
Organisation signing the contract : Oslo Universitetssykehus HF (hovedenhet)

6. Results

Direct award :
Justification for direct award : The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons
Other justification : Justification for direct procurement - Equipment for gradient separation of pancreatic tissue. This procurement concerns new equipment for gradient separation of island cells from pancreatic tissue at the Section for Cheetah (SfC), OUS. The current method with the use of Cobe 2991 with the accompanying consumption sets must be replaced. This involves the introduction of a new instrument and consumables at SfC. 2 Cellsaver Xtra will be procured from LivaNova AS. The estimated total volume is 15 procedures per annum. In cooperation with the Rüd gustave laboratory in Uppsala, a new process for gradient separation of eye cells from exocrine pancreatic tissue has been validated for use with the Xtra Auto Transfusion System (ATS) from LivaNova AS. We actively participate in the testing and method development of this new process. The Xtra ATS system has been physically tested at the Rüdlaboratoriet and together our tests have shown that the system provides the same or better quality in the form of morphology, purity and the stimulation index of island cells (SI). The cooperation with the SoHO regulation 2024/1938) as the SfC is decisive for maintaining standards and quality. Separation of island cells occurs through a gradient based on the cells and tissue density, with essential control of the rate of centrifugering to preserve cell quality. The process is being continually developed and we plan to transfer the gradient separation method using the Xtra ATS system to our island cell laboratory at SfC, but with the execution of the necessary tests for purity and contamination before final method approval at SfC. Given the technical requirements, methodical validation and regulatory considerations, LivaNova AS is considered as the sole supplier who can meet our needs, in accordance with the terms in PPR § 13-4 (2).

6.1 Result lot ldentifier : LOT-0000

6.1.2 Information about winners

Winner :
Official name : LivaNova Scandinavia AB
Tender :
Tender identifier : 77413
Identifier of lot or group of lots : LOT-0000
The tender was ranked : no
Subcontracting : No
Contract information :
Identifier of the contract : 77413
Organisation signing the contract : Oslo Universitetssykehus HF (hovedenhet)

8. Organisations

8.1 ORG-0001

Official name : Oslo Universitetssykehus HF (hovedenhet)
Registration number : 993467049
Postal address : Postboks 4956 Nydalen
Town : OSLO
Postcode : 0424
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Contact point : Frank Sætre
Telephone : 40204775
Roles of this organisation :
Buyer
Organisation signing the contract

8.1 ORG-0002

Official name : Oslo tingrett
Registration number : 926 725 939
Postal address : C. J. Hambros plass 4
Town : oslo
Postcode : 0164
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Telephone : 22035200
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : LivaNova Scandinavia AB
Size of the economic operator : Medium
Registration number : SE556441161801
Postal address : Djupdalsvägen 16
Town : Sollentuna
Postcode : 192 51
Country subdivision (NUTS) : Stockholms län ( SE110 )
Country : Sweden
Contact point : Fredrik Segelström
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0000
The winner is listed on a regulated market

Notice information

Notice identifier/version : 19903e38-8fb9-4520-b685-4fc980ea56ac - 01
Form type : Direct award preannouncement
Notice type : Voluntary ex-ante transparency notice
Notice dispatch date : 03/10/2025 12:44 +00:00
Notice dispatch date (eSender) : 03/10/2025 12:44 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00651170-2025
OJ S issue number : 191/2025
Publication date : 06/10/2025