Prostheses for open hybrid aortic surgery

PHI University Clinic for State Cardiac Surgery Skopje

Part 1 Stent graft system - Stent graft system (hybrid prosthesis) indicated for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta, for the treatment of acute aortic dissections extending deep into the descending aorta, acute aortic dissections combined with Marfan syndrome, extensive aortic dissection aneurysm of the ascending aorta or of the aortic arch extending to the descending aorta (also mycotic aneurysm), complex aortic dissections and chronic extensive aortic dissections which consists of two components: a self-expanding stent-graft with an embedded polyester vascular adapter and a system for delivery with a cuff - (collar) between the stent graft and the vascular adapter. The delivery system must be able to position and mount on the system for delivery. Proximal configuration – Aortic Cuff, Straight Open, Twin Stent Distal configuration - Straight Cut, Twin Stent, Straight open Variations with and without cuff. Stent graft length: 130mm - 160mm Graft length: 50mm - 70mm Proximal diameter: 20 mm - 40 mm Distal diameter: 20 mm - 40 mm Covered length: 80 mm - 240 mm Cuff diameter: 20 mm - 40 mm Cuff length: 10 mm - 150 mm Collar width: 2 mm - 40 mm Part 2 Diameter of Delivery System of the catheter: 36 mm- 48 mm Stent graft diameter 20 mm-40 mm A special hybrid stent graft for the treatment of ascending and descending aorta and aortic arch reconstruction. Made of woven polyester sealed with gelatin. The hybrid graft consists of a proximal surgical graft and a distal endovascular stent graft component supported by nitinol rings and positioning markers. In a set with a delivery and positioning system. Available in 2 configurations: Plexus and Ante-Flo Diameter of the proximal graft: 22 - 32mm, Diameter of branches: 8mm, 10mm and 12mm length 150mm Diameter of stent graft: 24 - 40mm Stent graft length: 100 and 150mm

Рок

Рокот за прием на понудите беше 2024-05-17. Набавката беше објавена на 2024-04-20.

Кој?

• PHI University Clinic for State Cardiac Surgery Skopje

Што?

• Функционална поддршка › Уреди за срцева поддршка

Каде?

• Северна Македонија › Скопски

Историја на набавките

Датум	Документ
2024-04-20	Оглас за договор

Оглас за договор (2024-04-20)
Предмет
Опсег на набавката
Наслов: Prostheses for open hybrid aortic surgery
Референтен број: 07121/2024
Краток опис:

Краток опис

Part 1
Stent graft system - Stent graft system (hybrid prosthesis) indicated for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta, for the treatment of acute aortic dissections extending deep into the descending aorta, acute aortic dissections combined with Marfan syndrome, extensive aortic dissection aneurysm of the ascending aorta or of the aortic arch extending to the descending aorta (also mycotic aneurysm), complex aortic dissections and chronic extensive aortic dissections which consists of two components: a self-expanding stent-graft with an embedded polyester vascular adapter and a system for delivery with a cuff - (collar) between the stent graft and the vascular adapter.
The delivery system must be able to position and mount on the system for delivery.
Proximal configuration – Aortic Cuff, Straight
Open, Twin Stent
Distal configuration - Straight Cut, Twin Stent,
Straight open
Variations with and without cuff.
Stent graft length: 130mm - 160mm
Graft length: 50mm - 70mm
Proximal diameter: 20 mm - 40 mm
Distal diameter: 20 mm - 40 mm
Covered length: 80 mm - 240 mm
Cuff diameter: 20 mm - 40 mm
Cuff length: 10 mm - 150 mm
Collar width: 2 mm - 40 mm
Part 2
Diameter of Delivery System of the catheter: 36 mm- 48 mm
Stent graft diameter 20 mm-40 mm
A special hybrid stent graft for the treatment of ascending and descending aorta and aortic arch reconstruction.
Made of woven polyester sealed with gelatin.
The hybrid graft consists of a proximal surgical graft and a distal endovascular stent graft component supported by nitinol rings and positioning markers.
In a set with a delivery and positioning system.
Available in 2 configurations: Plexus and Ante-Flo
Diameter of the proximal graft: 22 - 32mm,
Diameter of branches: 8mm, 10mm and 12mm length
150mm
Diameter of stent graft: 24 - 40mm
Stent graft length: 100 and 150mm

Вид на договорот: Стоки
Производи/услуги: Уреди за срцева поддршка 📦
Проценета вредност без ДДВ: 10 000 000 MKD 💰
Опис
Внатрешен идентификатор: 07121/2024
Опис на набавката:

Part 1 Stent graft system - Stent graft system (hybrid prosthesis) indicated for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta, for the treatment of acute aortic dissections extending deep into the descending aorta, acute aortic dissections combined with Marfan syndrome, extensive aortic dissection aneurysm of the ascending aorta or of the aortic arch extending to the descending aorta (also mycotic aneurysm), complex aortic dissections and chronic extensive aortic dissections which consists of two components: a self-expanding stent-graft with an embedded polyester vascular adapter and a system for delivery with a cuff - (collar) between the stent graft and the vascular adapter. The delivery system must be able to position and mount on the system for delivery. Proximal configuration – Aortic Cuff, Straight Open, Twin Stent Distal configuration - Straight Cut, Twin Stent, Straight open Variations with and without cuff. Stent graft length: 130mm - 160mm Graft length: 50mm - 70mm Proximal diameter: 20 mm - 40 mm Distal diameter: 20 mm - 40 mm Covered length: 80 mm - 240 mm Cuff diameter: 20 mm - 40 mm Cuff length: 10 mm - 150 mm Collar width: 2 mm - 40 mm Diameter of Delivery System of the catheter: 36 mm- 48 mm Stent graft diameter 20 mm-40 mm Part 2 A special hybrid stent graft for the treatment of ascending and descending aorta and aortic arch reconstruction. Made of woven polyester sealed with gelatin. The hybrid graft consists of a proximal surgical graft and a distal endovascular stent graft component supported by nitinol rings and positioning markers. In a set with a delivery and positioning system. Available in 2 configurations: Plexus and Ante-Flo Diameter of the proximal graft: 22 - 32mm, Diameter of branches: 8mm, 10mm and 12mm length 150mm Diameter of stent graft: 24 - 40mm Stent graft length: 100 and 150mm

Опис на набавката

Part 1
Stent graft system - Stent graft system (hybrid prosthesis) indicated for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta, for the treatment of acute aortic dissections extending deep into the descending aorta, acute aortic dissections combined with Marfan syndrome, extensive aortic dissection aneurysm of the ascending aorta or of the aortic arch extending to the descending aorta (also mycotic aneurysm), complex aortic dissections and chronic extensive aortic dissections which consists of two components: a self-expanding stent-graft with an embedded polyester vascular adapter and a system for delivery with a cuff - (collar) between the stent graft and the vascular adapter.
The delivery system must be able to position and mount on the system for delivery.
Proximal configuration – Aortic Cuff, Straight
Open, Twin Stent
Distal configuration - Straight Cut, Twin Stent,
Straight open
Variations with and without cuff.
Stent graft length: 130mm - 160mm
Graft length: 50mm - 70mm
Proximal diameter: 20 mm - 40 mm
Distal diameter: 20 mm - 40 mm
Covered length: 80 mm - 240 mm
Cuff diameter: 20 mm - 40 mm
Cuff length: 10 mm - 150 mm
Collar width: 2 mm - 40 mm
Diameter of Delivery System of the catheter: 36 mm- 48 mm
Stent graft diameter 20 mm-40 mm
Part 2
A special hybrid stent graft for the treatment of ascending and descending aorta and aortic arch reconstruction.
Made of woven polyester sealed with gelatin.
The hybrid graft consists of a proximal surgical graft and a distal endovascular stent graft component supported by nitinol rings and positioning markers.
In a set with a delivery and positioning system.
Available in 2 configurations: Plexus and Ante-Flo
Diameter of the proximal graft: 22 - 32mm,
Diameter of branches: 8mm, 10mm and 12mm length
150mm
Diameter of stent graft: 24 - 40mm
Stent graft length: 100 and 150mm

Поштенска адреса: Majka Tereza 17/building no. 8
Град: Skopje
Земја: Северна Македонија 🇲🇰
Место на извршување: Скопски 🏙️
Времетраење: 12 месеци
Наслов
Идентификациски број на делот: LOT-0001

Постапка
Вид на постапката
Отворена постапка ✅
Правна основа: Директива 2014/24/ЕУ
Административни информации
Рок за прием на понуди или барања за учество: 2024-05-17 13:00:00 📅
Услови за отворање на понудите: 2024-05-17 13:00:00 📅
Услови за отворање на понудите (место): PHI University Clinic for State cardiac Surgery – Skopje, Majka Tereza 17/8
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Минимален временски рок во кој понудувачот мора да ја одржи понудата: 90 дена
Информации за рамковен договор или динамичен систем за купување
Рамковен договор со повеќе оператори ✅
Услови за тендер
Датум на отворање: 2024-05-17 13:00:00 📅
Место: PHI University Clinic for State cardiac Surgery – Skopje, Majka Tereza 17/8
Краен рок за барање дополнителни информации: 2024-05-09 15:30:00 📅

Правни, економски, финансиски и технички информации
Економска и финансиска состојба
Список и краток опис на критериумите за избор:

statement of the economic operator that no effective verdict has been pronounced against the economic operator within the past five years for a committed crime stated in Art. 88, paragraph 1 of the LPP; - certificate stating that no bankruptcy procedure has been initiated by a competent body; - certificate stating that no liquidation procedure has been initiated by a competent body; - certificate of paid taxes, contributions and other public duties issued by a competent body in the country where the economic operator is registered; - certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - ban on participating in open call procedures, awarding public procurement contracts and contracts on public - private partnership has been pronounced; - certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - temporary or permanent ban on performing particular activity has been pronounced; - certificate stating that no misdemeanor sanction - ban on the performance of the profession, activity or duty, i.e. temporary ban on the performance of a particular activity has been pronounced with an effective verdict.

Техничка и професионална способност

- Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered - Decision for placing medical device on the market, with correctly marked positions that are subject to procurement, pursuant to the Law on Medicines and Medical Devices

Услови за учество
Список и краток опис на условите:

- Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered. – Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.

Основа за исклучување:

Виновен за тешко професионално недолично однесување

Плаќање даноци

Состојба слична на стечај според националното законодавство

Договорен орган
Име и адреси
Име: PHI University Clinic for State Cardiac Surgery Skopje
Национален регистарски број: 6928854
Поштенска адреса: Majka Tereza 17/building no. 8
Поштенско место: Skopje
Регион: Скопски 🏙️
Земја: Северна Македонија 🇲🇰
Контактна точка: Ivica Ristevski
Е-пошта: ristevski.ivica@gmail.com 📧
Телефон: 0038978498901 📞
Вид на договорниот орган
Тело уредено со јавно право
Главна дејност
Здравство
Комуникација
URL на документи: https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/bd72f07b-55f2-42f7-a157-9789933d609f/1 🌏
URL за учество: https://www.e-nabavki.gov.mk/ 🌏
Електронско поднесување: Дозволено

Дополнителни информации
Тело за преглед
Име: State Commission for Public Procurement Appeals
Национален регистарски број: 6428045
Поштенска адреса: Majka Tereza 17/building no. 8
Поштенско место: Skopje
Регион: Скопски 🏙️
Земја: Северна Македонија 🇲🇰
Е-пошта: dkzjn@gs.mk 📧
Телефон: 0038923251260 📞
Извор: OJS 2024/S 080-240148 (2024-04-20)

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