Heart valve innovation · Florida, USA

Engineering a new path for polymeric heart valves.

Polymeric Heart Technology is developing the Expandable Polyurethane Trivalve Stent, a pediatric heart valve prosthesis that unites polymer science, precision engineering, and transcatheter delivery.

Florida LLCUnited States platform
Polymer + Co–CrIntegrated valve architecture
TranscatheterBalloon-expandable concept
Expandable Polyurethane Trivalve Stent prototype with transparent polyurethane leaflets and an integrated metallic stent
PHT VALVE PROTOTYPEExpandable Polyurethane Trivalve Stent

FROM SCIENCE TO CLINICAL POSSIBILITY

A platform created to rethink durability, adaptability, and long-term care.

01 / TECHNOLOGY

One integrated valve platform

The Expandable Polyurethane Trivalve Stent integrates three flexible polyurethane leaflets with an expandable cobalt–chromium stent in a compact, balloon-expandable system.

01

Expandable platform

A cobalt-chromium stent architecture designed for controlled balloon expansion.

02

Polymeric leaflets

Three medical-grade thermoplastic polyurethane leaflets engineered for flexibility and repeated cardiac cycles.

03

Transcatheter delivery

A valve platform under development for pulmonary and future aortic applications.

Platform architecture

Built around three essential components.

A controlled interface between structure, leaflets, and delivery is central to the development program.

01

Cobalt–chromium stentLaser-cut expandable structure

02

Medical-grade TPUThin, flexible polymeric leaflets

03

Balloon catheterControlled delivery and expansion

THE VALVE IN MOTION

Three leaflets. One coordinated cycle.

SCHEMATIC · END-ON VIEWClosing / leaflet coaptation
Expandable Polyurethane Trivalve Stent: opening and closingThree polyurethane leaflets move away from the center to open, then meet in the center to close. The surrounding stent remains stationary during the illustrated cardiac cycle.123Expandable stent3 polyurethane leaflets
Right ventriclePulmonary artery

Expandable Polyurethane Trivalve Stent

The stent supports the leaflets. Balloon expansion is a separate procedure; the stent does not expand with each heartbeat.

Illustrative mechanism only. Geometry, leaflet motion, flow, and cycle timing are schematic and do not represent measured device performance. Investigational technology.

02 / PEDIATRIC FOCUS

Expandable Polyurethane Trivalve Stent

PHT’s pediatric polymeric heart valve prosthesis combines three polyurethane leaflets with an expandable stent. Developed for pulmonary valve replacement, the concept is designed with growing hearts in mind.

PEDIATRIC GROWTH

InitialExpandedFuture

One platform. Multiple diameters.
A balloon-expandable architecture conceived for controlled enlargement over time.

01

Pulmonary application

Focused on transcatheter pulmonary valve replacement for pediatric and congenital heart disease pathways.

02

Growth-aware architecture

The expandable cobalt–chromium frame is being engineered to accommodate planned increases in diameter as the patient grows.

03

Long-term objective

The development goal is to reduce the burden of repeated valve replacement procedures while preserving future treatment options.

Investigational concept. Safety, performance, expandability, and clinical benefit must be established through preclinical and clinical evaluation and regulatory review.

03 / DEVELOPMENT

Evidence-led development

PHT is organizing the next phase of industrial, quality, regulatory, and clinical work around a controlled development pathway.

Preclinical foundation

Historical development includes bench testing, fatigue evaluation, preclinical implantation, and explant analysis. All external claims remain subject to documented regulatory and scientific review.

  • Bench hydrodynamic evaluation
  • Accelerated fatigue testing
  • Preclinical ovine studies
  • Material and structural analysis

DEVELOPMENT PATHWAY

01
Design & materials

Valve geometry, stent architecture, and polymer selection

02
Process development

Coating and molding process evaluation

03
Verification

Hydrodynamic, fatigue, and structural testing

04
Clinical pathway

Regulatory engagement and study planning

04 / COMPANY

Science, enterprise, and execution

SHT and PHT contribute distinct capabilities while preserving clear institutional roles in Brazil and the United States.

BR

SHT

Scientific origin, historical research, and foundational technology in Brazil.

US

PHT LLC

U.S. enterprise for development, industrialization, and future production.

1977Cardiac prosthesis research begins
2013Synthetic Heart Technology founded in Brazil
2026Polymeric Heart Technology established in Florida
NextIndustrial and clinical development in the United States

05 / LEADERSHIP

Multidisciplinary by design

Clinical experience, engineering, industrial development, and business execution come together around one mission.

Miguel Angel Maluf, MD, PhD portrait01

Miguel Angel Maluf, MD, PhD

Founder · Clinical & Scientific Leadership

Marcelo Dias portrait02

Marcelo Dias

Engineering & Industrial Development

Marcio Velten portrait03

Marcio Velten

Business Development

Build the future with us

Advancing polymeric valve technology through collaboration.

Polymeric Heart Technology LLC

1905 Intermodal Circle, Suite 320
Palmetto, Florida 34221 · USA