Sorin Group Receives FDA Approval for the Production of Carbomedics Valves in Saluggia

The Food and Drug Administration inspection of the heart valves
manufacturing site in Saluggia (Vercelli, Italy) has successfully
completed. The production of the Carbomedics valves has been moved
from Austin (Texas, USA)

Sorin Group (MIL:SRN), worldwide leader in cardiac surgery
solutions, received the clearance from FDA to manufacture Carbomedics
mechanical heart valves in the firstclass manufacturing facility in
Saluggia (Vercelli, Italy).
The inspection performed by the FDA on the Heart Valves Business
ended successfully. This result represents not only an important
acknowledgement of the high quality standards of the Sorin valves
production processes, but also a fundamental step in the industrial
integration and consolidation process of the Group.
While the production of mechanical cardiac valves has been
consolidated in one firstclass manufacturing facility in Saluggia
(Vercelli, Italy), the Austin facility will continue to serve as the
assembly location of the finished products for the North American
market.
This production shift will enable the Group to benefit from
economies of scale and exploit the technological knowhow developed
through the work carried out in Saluggia over several decades. Since
1977, hundreds of thousands of mechanical valves have been
manufactured at Saluggia, and have been implanted in more than 70
countries without any structural malfunction.
"We are extremely proud and excited about this important result,
which is the evidence of the excellent quality of our people and
manufacturing processes of the Sorin Group", said Franco Vallana,
President Cardiac Surgery Business Unit.
The benefits that this integration effort is expected to produce
include: greater operational flexibility in managing brands and
product lines, enabling the Group to respond to any shifts in market
demand; major economies of scale and reduction of manufacturing costs;
and greater integration between the manufacturing and R&D
organizations.
Drago Cerchiari, Sorin's CEO, declared: "This production
relocation will result in a strategic reinforcement of the overall
Cardiac Valves area, which will benefit from the world's greatest
concentration of medical technology resources and product specific
knowhow."

About Sorin Group

Sorin Group (Reuters code: SORN.MI), a world leader in the
development of medical technologies for cardiac surgery, offers
innovative therapies for cardiac rhythm dysfunctions, interventional
cardiology and the treatment of chronic kidney diseases. The companies
of Sorin Group are: Bellco, CarboMedics, COBE Cardiovascular, Dideco,
ELA Medical, Mitroflow, Soludia, Sorin Biomedica and, Stockert. Sorin
Group has about 4,800 employees working at facilities in more than 80
countries throughout the world to serve over 5,000 public and private
treatment centers.

For additional information, please visit our website:
www.sorin.com