Centro deConstrucción de Cardioestimuladores

Overview On February 3, 1960, Prof. Orestes Fiandra

performed the first effective pacemaker implant in the world.

CCC was founded in 1970 dedicated to the development and manufacture of pacemakers

We have 30 years of experience in the medical devices field and we are expanding activities to other engineering areas.

A brief history 70’s: Design and manufacture of pacemakers for

the domestic market

80’s: Assembly of kits supplied by Exonix

90-94: Development of APEX series

95: Starting international business

97: Starting engineering and OEM business

02: Offices in Europe (i2m)

Today Some years of experience in the

global market

Two divisions: Pacemakers Engineering

Engineering Division We aim at the development of specific projects

through direct agreements with customers, or by participating in agreements with other solution supplier companies.

We have developed a substantial set of framework solutions and thoroughly tested modules; so, we can offer short lead times with uncompromising quality.

We can offer rapid development of prototypes and new products together with high quality standards and low cost

Our work is not limited to the medical devices field

Electronics Design, prototyping and circuit

manufacture according to applicable international medical quality standards.

Design and manufacture of monitoring devices.

Design and manufacture of micro-power implantable circuits.

Design of Application Specific Integrated Circuits (ASICs).

Firmware Development of embedded systems

software, including real-time systems, signal processing, and communications.

Development of complex systems involving real-time parallel processing.

Development of microcontroller-based ultra-low power consumption solutions.

High-level Software Development of high-level software, including

Graphical User Interfaces and software for the command of embedded systems.

Development of special-purpose languages aimed at simplifying maintenance and operation tasks.

Development of communications software, used with devices designed by CCC or by third parties

Remote operation through the Internet.

Integration of Data Base services.

Leads and Encapsulation Design and Manufacture of special purpose,

chronically-implantable leads.

Medical-grade encapsulations including titanium and epoxy enclosures.

Mechanical solutions for medical devices

Medical-grade packaging, including blister packs and ETO sterilization.

Project Leadership & Consulting Project management and leadership of mission-

critical projects, integrating our capacity and engineering capabilities with the customer’s resources.

Wide experience in international multi-center projects.

Feasibility studies in areas such as micro-power electronics, real time software development.

Consulting services in Software Engineering and SQA. 

The innovation path

Basic Research

Applied Research

Customer Services

Distribution

Manufacture

Lab Prototype

Industrial Prototype

Product

Market Pull

Technology Push

ourservices

Some clients and partnersIllini Group

Neurostream

Example From the lab to CE mark and FDA

approval Start-up company from US - Israel CCC:

1998: lab prototype 1999: 1st implantable prototype (animals) 2000: refinements, prototypes 2001: clinical trials (Italy) - Starting CE Mark 2002: CE Mark 2003: developing a new model

Pacemaker Division Pacemakers & Leads:

Uruguay: direct sales

Latin America: Distributors

Circuits & Parts:

Russia

India

Pacemaker Division We are focused in design and

manufacture activities

We are expanding Sales capabilities

We are looking for partners able to promote and commercialize our products

Products Pacemakers

ALFA, external APEX series

• long duration ARGOS series

• small size TEROS series

• Based in CCC ASIC Neuro

• Research centers

Cardiomyoplasty LD-PACE II

Commercialized by Illini Group

Leads Unipolar IS-1

Bipolar IS-1

Cardiomyoplasty

Argos Series SSI – SSIR Hybrid circuits Small size

External Pacemakers Custom

Holters Signal

acquisition Specific

stimulators

Programmer One programmer for all series

Easy to use Log

ECG display Remote monitoring Custom data base developments

New developments Teros DDD, DDDR

2nd quarter 2004 Teros SSI, SSIR

First implant, October 2003 Implantable Defibrillator: starting

4th quarter 2003

Quality Assurance ISO 9000:2000 ISO 13485 Inspections and reviews

Design reviews Quality Systems Audited by the Client

SQA Audited by DHC Associates

British Standards Institute Successfully audited in March 2002,

March 2003

Strategic Partners and Clients

Impulse Dynamics – USA, Israel

CNM, Europe (i2m)

LMT – Russia Aeromedical, Argentina

Thank you...