Patient Receives VProtect(TM) Luminal Shield In First-Ever Vulnerable Plaque Clinical Trial

An
interventional cardiology team led by Professor Patrick W. Serruys
successfully placed a vProtect(TM) Luminal Shield in the left anterior
descending (LAD) coronary artery of a 64-year-old man at Erasmus Medical
Center in Rotterdam. This case marks the start of a pilot study, known as
SECRITT I, designed to evaluate the vProtect(TM) Luminal Shield as a
treatment for vulnerable plaques -- atherosclerotic deposits in the
coronary arteries that do not produce symptoms until they rupture with
potentially fatal consequences. There are more than 500,000 sudden cardiac
deaths in the US, and more than 300,000 in Europe, every year. The sudden
and unexpected passing of Tim Russert, host of NBC's Meet the Press, is
thought to have been the result of a vulnerable plaque rupture.



The SECRITT investigators plan to place the self-expanding vProtect(TM)
Luminal Shield in 15 patients with plaques identified as vulnerable by a
combination of ultrasound and optical imaging techniques. These patients
will be matched with 15 controls-patients who also have
non-blood-flow-limiting plaques or "lesions" that have been identified as
vulnerable-who will not receive the Shield. All patients are elective
patients that have been referred to the cathlab for the treatment of a
major lesion impairing normal cardiac function. All 30 patients will
undergo follow-up diagnostic catheterizations 6 months after the initial
treatment visit, at which time their lesions will be re-evaluated. This
information will enable the investigators to observe whether the Shield has
stabilized the target lesions.



According to Professor Patrick W. Serruys, MD, PhD, of Erasmus
University, the SECRITT I trial represents the logical extension of modern
cardiac medicine: "We are very good at opening arteries that are blocked,
but we have not succeeded in preventing heart attacks related to plaque
rupture. The kind of plaques we are treating in SECRITT do not cause
symptoms or seriously affect blood flow, but they are prone to rupture,
which can cause a clot, or thrombus. The vProtect(TM) Luminal Shield is
designed to prevent that rupture, thereby preventing the thrombus, and the
resulting heart attacks." Professor Serruys has been the Director of the
Clinical Research Program of the Catheterization Laboratory at the
Thoraxcenter, Erasmus University since 1980 and the Head of the
Interventional Cardiology Department since 1997. He is a Fellow of the
American College of Cardiology and the European Society of Cardiology and a
member of the Scientific Council of the International College of Angiology.



Recent studies have shown that most "culprit" lesions in heart attacks,
or myocardial infarctions (MI) narrow the vessel lumen by less than 50%
prior to the infarct, and only 15% of acute, or sudden, MIs arise from
lesions that are more than 60% narrowed on a previous angiogram. Most of
these vulnerable plaques would not be eligible for treatment with
angioplasty and stenting. "Now is the time to take a new approach, to try
and prevent the plaque rupture and prevent the acute event, rather than try
to repair the damage after the fact," said Professor Serruys.



The vProtect(TM) Luminal Shield is also undergoing clinical testing for
indications where traditional stents are used -- relatively stable,
flow-limiting coronary lesions. "The Shield was designed for use in soft
lesions. The features that make it well suited for use in vulnerable plaque
-- including gentle, self-expanding deployment and ultra-thin struts --
make it useful in other lesions where traditional balloon-expanding stents
are currently used," said Patricia Scheller, Chief Executive Officer of
Prescient Medical. "There are some uses for which traditional stents do not
perform optimally, such as in patients with acute coronary syndrome. These
patients often have plaques that recently ruptured, and are prone to
developing clots. The vProtect(TM) Luminal Shield was designed to match the
mechanical properties of the coronary artery. It doesn't cause the same
amount of injury as balloon-expandable stents, which should reduce some of
the adverse effects associated with traditional stents," she concluded.



About Prescient Medical, Inc.



Prescient Medical, Inc. is a privately held medical device company
dedicated to reducing deaths from heart attacks, the leading cause of death
in much of the world.


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