Polymeric Heart Valve Prosthesis "EvRos-MI" Model ALM

Polymeric Heart Valve Prosthesis "EvRos-MI" Model ALM — MedInzh CJSC

Name: Polymeric Heart Valve Prosthesis "EvRos-MI" Model ALM
Brand: EvRos-MI
SKU: 111552
Availability: InStock

Brand: EvRos-MI

$900 - $3,000 USD

MOQ: 2 pieces

Key Features

Seating diameter: 27 mm

Application area of the prosthetic heart valve: cardiovascular surgery, designed for prosthetic damaged pulmonary valve

design: Polymer tube and valve; locking elements and protrusions; mimicking Valsalva sinuses. The polymer tube is a segment of a vascular prosthesis. The locking element contains thin and pliable flaps.

MRI compatibility: fully compatible

Supplier Information

MedInzh CJSC

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Description

The EvRos-MI (ЕвРос-МИ) is a polymeric heart valve prosthesis manufactured by MedInzh Scientific Production Enterprise (ЗАО НПП «МедИнж»), a Russian developer and producer of implantable medical devices based in Penza. The prosthesis is designed specifically for replacement of a diseased pulmonary artery valve in adult cardiovascular surgery.

Built entirely from porous polytetrafluoroethylene (ePTFE), it offers a fully synthetic alternative to pulmonary valves sourced from xenograft or allograft tissue, eliminating donor-tissue dependency while delivering long-term structural stability. The device consists of two main elements: a polymeric conduit — fabricated as a segment of vascular prosthesis — and a valve assembly that includes closing elements and prominences engineered to replicate the natural sinuses of Valsalva.

The thin, supple leaflets are designed to open and close smoothly under the characteristically low differential pressures of the right-heart circuit. The EvRos-MI features a 27 mm seating diameter suited to adult anatomy and is fully compatible with MRI, enabling unrestricted post-operative diagnostic imaging.

Its principal clinical advantage is high resistance to both calcification and ingrowth of surrounding tissue into the outer conduit surface — the two leading mechanisms of structural failure in biological valve substitutes.

Details & Equipment

Product Design

Two-Component Construction

The EvRos-MI consists of a porous ePTFE polymer conduit and an integrated valve assembly with prominences replicating the sinuses of Valsalva. Thin, pliable leaflets open and close under low differential pressure.

Clinical Prosthesis

The assembled 27 mm prosthesis is designed for adult pulmonary artery valve replacement, offering high resistance to calcification and tissue ingrowth into the conduit outer surface.

Features

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ePTFE Polymer Construction

Fabricated from porous polytetrafluoroethylene, providing long-term biomaterial stability without the structural degeneration associated with xenograft or allograft tissue.

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Calcification Resistance

Engineered for high resistance to calcification and to fibrous tissue ingrowth into the outer conduit surface — the primary failure modes of biological pulmonary valve substitutes.

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Sinuses of Valsalva Design

The valve assembly includes prominences that replicate the natural sinuses of Valsalva, supporting physiological flow dynamics around the leaflets during the cardiac cycle.

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Low-Pressure Leaflet Function

Thin, pliable leaflets that open and close reliably under the low differential pressures characteristic of the pulmonary circulation, closely mimicking native valve behavior.

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Full MRI Compatibility

Fully MRI-compatible, enabling comprehensive post-operative cardiac imaging without restriction or contraindication for long-term patient monitoring.

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27 mm Seating Diameter

Standardized 27 mm seating diameter for adult patients, suitable for right-heart outflow tract implantation in routine cardiovascular surgery.

Buyer Benefits

Synthetic ePTFE material eliminates dependence on donor tissue — no xenograft or allograft supply constraints
Superior long-term durability: high resistance to calcification extends prosthesis functional lifespan compared to biological alternatives
Tissue ingrowth resistance protects conduit integrity and prevents structural failure from fibrous encapsulation on the outer surface
Full MRI compatibility supports unrestricted post-operative cardiac surveillance and follow-up imaging
Low-pressure leaflet design matches the hemodynamic demands of the pulmonary position, reducing mechanical wear
Two-component modular construction (polymer conduit + integrated valve) allows intraoperative adaptation during implantation
Domestically manufactured in Russia by a certified implantable medical device producer, supporting national health procurement programs

Applications

Pulmonary artery valve replacement in adult cardiovascular surgery Right-heart outflow tract reconstruction requiring a conduit with an integrated valve Re-operative cardiac surgery where prior biological prostheses have undergone calcific degeneration Congenital heart defect correction involving the pulmonary valve or right ventricular outflow tract Procedures where xenograft or allograft tissue supply is limited or clinically contraindicated Post-implant MRI surveillance programs requiring fully imaging-compatible cardiac prostheses Cardiovascular centers with standardized pulmonary valve replacement protocols Institutional procurement under domestic medical device supply programs (44-FZ, national health equipment tenders)

Source: official manufacturer website