Company Report

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ICR - Volume 3 Issue 1;2008:3(1):1-3

Iberhospitex S.A., located in Spain (Barcelona area), was founded in 1980 and is dedicated to manufacturing, distributing and exporting disposable medical products for hospitals and clinics. It has been steadily growing and today employs more than 180 people with facilities totalling over 5000m2.

The central installations and main offices are located in Barcelona, Spain, where manufacturing and research and development (R&D) take place.

We offer a personal and direct service to all our international clients. Our facilities include our own laboratory and R&D department, offices and production units (4000 m2), warehouse (1,800 m2), clean rooms (class 1,000 and 10,000) and sterilisation units.

Iberhospitex, S.A. currently manufactures two complete ranges of highquality disposible medical products under the trademark IHT and cordynamic. The IHT products (drainage/suction systems, heat/moisture exchangers and self adhesive dressings) and cordynamic catheters and stents for diagnosis and treatment of coronary arteries.

During the 1990s, Iberhospitex S.A. decided to expand and diversify its activity with high added-value products, and consequently developed the cordynamic range of catheters and stents for cardiovascular angiography and angioplasty. Today, cordynamic is the result of nine intensive years of R&D.

Subsequently, we started to venture outside the Spanish borders and today our products are present in over 40 countries all over the world, through exclusive distribution agreements. The company also has a subsidiary in France.

Our products have always maintained the highest quality and design standards (ISO 9001), thus satisfying the requirements and needs of our distributors, hospital staff and haemodynamists.

Years of R&D of products in two different fields, the presence of these products in more than 40 countries all over the world (including our subsidiary in France), the accumulated experience of 28 years in the market, the versatility of having a production plant and laboratory under the same roof and the quality of service offered by Iberhospitex S.A. to international clients guarantee the quality of our products.

Key Milestones in Our History

In 1990 IHT Medical was founded, a company dealing with the import and distribution of disposable hospital supplies in the Spanish market. In 1993, with a view to expanding internationally, Clinical IHT was founded in France for the purpose of marketing IberhospitexÔÇÖs products there. In 1998 Iberhospitex set up the cordynamic division, a complete product line for interventional cardiology, born of the R&D work undertaken by the company.

In 2001-2002 Iberhospitex broadened its structure in both R&D and international departments, giving them the necessary material and human resources to meet the challenges ahead.

In 2003 Iberhospitex opened the new logistics plant at Montmel├│.

In 2004 Iberhospitex reinforced its management team in order to speed up its development process.

Quality as a Strategic Objective
Guarantee of High Quality and Design Standards

ÔÇó ISO 9001 certified since 1997.
ÔÇó CE certification for all our products based on the latest ISO 9001 version (ISO 13485).
ÔÇó For cordynamic: complete process certified including design, production and total quality ISO 46001 (13485).
ÔÇó Continuous analysis and control of all departmentsÔÇÖ processes.

Explora - Angiography diagnostic catheter has:

ÔÇó excellent visibility;.
ÔÇó high flow rate;
ÔÇó excellent torque;
ÔÇó for enhanced performance; and
ÔÇó atraumatic tip.

Access guiding catheter - excellent design for unique performance has flat braiding with a 2-2 alternation combining high stiffness with maximum flexibility and provides a balance of:

ÔÇó pushability;
ÔÇó torque;
ÔÇó no kinking; and
ÔÇó support.

Combining the most demanded characteristics of the market:

ÔÇó maximum lumen due to flat/flat braifing saving space;
ÔÇó more slippery due to Tefl├│n inner layer; and
ÔÇó more bio-compatible properties.

EasyWay2: The balloon that clears the way and offers:

ÔÇó rapid exchange balloon catheter;
ÔÇó kissing balloon compatibility in 6F guides;
ÔÇó crosses with excellence;
ÔÇó dilates efficiently;
ÔÇó tracks better; and
ÔÇó reaches further.

Apolo3: Bare-metal coronary stent is the result of the evolution and success of our Apolo Stent. It has allowed us to optimise the essential characteristics for an easy implantation. It has:

ÔÇó enhanced crossability;
ÔÇó increased regularity of expansion;
ÔÇó improved stent retention; and
ÔÇó adjusted balloon overhang.

Apolo stent is also offering a specific design for small vessels:
Apolo Small.

AmiCath is designed for a safer, easier primary angioplasty in AMI. It is a unique device, specially designed to enhance the decision-making process in primary angioplasty, with efficacy and safety.

It recanalises the artery with 'dotterÔÇÖ effect instead of balloon predilatation reducing the risk of distal embolisation (4%, compared with 15% in balloon predilatation series).

AmiCath allows the preparation of microcirculation to prevent reperfusion injury before recanalisation injecting drugs such as adenosine or nicorandil. It also helps to select which patient will need thrombus aspiration. It facilitates 'direct stentingÔÇÖ thanks to distal vessel visualization and lesion length measurement.

Bionert: Oxygen ionic implantation inert stent is innovative ionic implantation technology. It is developed by Iberhospitex and ensures low restenosis rate. It is:

ÔÇó nickel ion migration is blocked;
ÔÇó based on Apolo3 and Apolo Small designs;
ÔÇó binary restenosis: 10.8%;
ÔÇó TLR: 3.3%;
ÔÇó late Loss (mm): 0.82 ┬▒ 0.32; and
ÔÇó MACE: 4.6%.

Active: Paclitaxel DES with slow release acrylic polymer with Triflusal has:

ÔÇó Apolo 3 and Apolo Small platform;
ÔÇó paclitaxel micro-tubule stabilising drug;
ÔÇó acrylic polymer with Trifusal; and
ÔÇó complete drug release.

Our polymer is fixed on the stent due to a unique and proprietary Iberhospitex-cordynamic process providing excellent physical-mechanical properties such as:

ÔÇó no modification of mechanical integrity;
ÔÇó surface protection;
ÔÇó non crackable;
ÔÇó easy balloon withdrawal;
ÔÇó non-fragment detachment; and
ÔÇó drug release homogeneity.

Our polymer has been specifically designed for application in DES, providing:

ÔÇó high molecular weight;
ÔÇó high hydrolytic stability;
ÔÇó good drug loading;
ÔÇó high biocompatibility;
ÔÇó biostable;
ÔÇó antiplatelet; and
ÔÇó anti-inflammatory.

The Triflusal, which is an antiplatelet joining agent chemically bound to the polymer, confer biocompatible properties to the polymer and reduction of platelet adhesion.

The antiproliferative drug is paclitaxel and it is fully released after 60 days.

Irist: Simvastatin DES with slow release acrylic polymer with Triflusal:

ÔÇó Apolo 3 and Apolo Small platform;
ÔÇó Simvastatin drug-eluting stent;
ÔÇó Acrylic polymer with Trifusal; and
ÔÇó Complete drug release.

Our polymer is fixed on the stent due to a unique and proprietary Iberhospitex-cordynamic process providing excellent physical-mechanical properties such as:

ÔÇó no modification of mechanical integrity;
ÔÇó surface protection;
ÔÇó non crackable;
ÔÇó easy balloon withdrawal;
ÔÇó non-fragment detachment; and
ÔÇó drug release homogeneity.

Our polymer has been specifically designed for application in DES providing:

ÔÇó high molecular weight;
ÔÇó high hydrolytic stability;
ÔÇó good drug loading;
ÔÇó high biocompatibility;

ÔÇó biostable;
ÔÇó antiplatelet; and
ÔÇó anti-inflammatory.

The drug of our IRIST stent is simvastatin, a hypocholesterolemic drug bringing optimum safety as it is non-cytotoxic and non-inflammatory.

Antiproliferative properties are also selective as there is inhibition of smooth-muscle cells without affecting endothelial cells growing.

Hunter: Thrombus extraction catheter has:

ÔÇó flat/flat braiding providing maximum pushability and high kinking resistance; and
ÔÇó enlarged extraction lumen for maximum thrombus aspiration Ôûá