InFlow Valve

About InFlow valve

Breakthrough concept and solution
with IP protection

Our InFlow transcatheter aortic valve implants will allow the TAVI technology to be expanded to a much younger population, thanks to the high durability and low risk of valve degeneration.

Our innovations drive the change in transcatheter heart valve treatment

  • 01. Biocompatible polymer
  • 02. Unique biological material
  • 03. True 14Fr profile
  • 04. Self-positioning implantation system
  • 05. Atraumatic tip
  • 06. Proprietary stent design
  • 07. Simplified TAVI procedure
DISRUPTIVE TECH

InFlow polymeric valve

Medical-grade polymer material with proven biocompatibility. Simplified, low-cost, environment-friendly valve production.

The InFlow polymeric valve stands as a groundbreaking innovation, offering expected, extended durability exceeding 20 years, surpassing traditional biological valves. The polymeric valve allows to approach a broader market, by making the valves applicable for younger patients.

InFlow polymeric valve features

  • 01. Medical-grade polymer material
  • 02. Proven biocompatibility and mechanical strength (preclinical studies)
  • 03. Potential for endothelialization of leaflet surface
  • 04. Exceptional durability – over 20 years, specifically suitable for younger patients

Technology for production

  • 01. Vent like concept for aortic valve
  • 02. Sutureless – polymer attached to the metal frame using proprietary electrospinning method
  • 03. Simple commissure formation by attachment of suspensions to the stent frame
  • 04. Low production costs with environment-friendly solutions
UNIQUE SOLUTION

InFlow biological valve

Our InFlow biological valve is characterized by high biocompatibility and resistance to degeneration.

Our own supply of high quality biological material for valve production is a key competitive advantage.

INFLOW biological valve features

  • 01. Decellularized biological material
  • 02. Proven biocompatibility and mechanical strength (preclinical studies)
  • 03. High resistance to valve leaflet degeneration

Technology for production

  • 01. Vent like concept for aortic valve
  • 02. Simple commissure formation by attachment of suspensions to the stent frame
  • 03. Proprietary biological material derived from the pericardium of transgenic domestic pigs
INFLOW

Benefits of our InFlow polymeric
& biological valves

Our transcatheter aortic valve implants, especially the polymeric variant, will be applicable for younger patients due to the extended durability.

  • Benefits for patients

    Faster recovery, shorter stay at the hospital, reduced trauma and pain, less noticeable scars

    Shorter waiting time for the procedure

    A lower risk of perioperative complications and death rate

    Personalized valve implant

  • Benefits for cardiologists

    Simplified procedures to be performed immediately after diagnosis

    Low risk of the procedure, short hospitalization with low side effect rate

    Easier re-operation and more straightforward procedures

  • Benefits for cardiac centers

    Facilitation and simplification of the procedure

    Larger scope of procedures delivered without any delay

    Decrease in procedure costs for hospitals and cardiac centers

Positive results in animal models

We have introduced a proprietary ovine banding model of aortic stenosis for stable fixation during valve implantation. Two separate preclinical studies have been conducted with biological and polymeric aortic valves, involving 24 and 26 sheep. The short and long-term (30-180 days) observation confirmed feasibility and safety as well as excellent hemodynamic function and high biocompatibility of the new InFlow TAVI.

Polymeric InFlow valve preclinical
study results
  • 01. Optimal hemodynamic performance and healing, with no valve degenerations at 6 month follow-up in an ovine preclinical study
  • 02. No calcifications or significant stenosis, regurgitation or peri-valvular leak in echocardiography
  • 03. Leaflets remained free from thrombi and calcifications in all cases
  • 04. Complete material endothelialisation

Mateusz Kachel, Piotr Buszman et al., Frontiers in Cardiovascular Medicine, 2022 Frontiers | Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model

Biological InFlow valve preclinical
study results
  • 01. Long-term (6-month) observation was feasible with low mortality and no valve degeneration at 6 month followup in an ovine preclinical study
  • 02. Echocardiography showed good hemodynamic outcomes and no structural valve deterioration
  • 03. TAVI and anchoring of valves was achieved in all cases with high procedural success
  • 04. No valve degeneration at 1, 3 and 6 month follow-up

Piotr Buszman, Mateusz Kachel et al., Cardiology Journal, 2023 6-Month Evaluation of a Transcatheter Aortic Valve (Myval) in a Novel Ovine, Supra-Aortic Banding Model - PMC