Navigation Links
Patient Receives vProtect(TM) Luminal Shield in First-Ever Vulnerable Plaque Clinical Trial
Date:6/30/2008

Prescient Medical - SECRITT I Study to Evaluate Preventive Treatment of

Potentially Life Threatening Vulnerable Plaques

ROTTERDAM, Netherlands and DOYLESTOWN, Pa., June 30 /PRNewswire/ -- 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.

For more information on Prescient Medical or its products please contact Ilana Odess, General Manager of Prescient Medical, at (917) 941-9990 or via e-mail: iodess@pmivp.com.

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. For more information, please visit our website at http://www.prescientmedical.com or call +1-866-376-0500.


'/>"/>
SOURCE Prescient Medical
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
3. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
6. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
7. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
8. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
9. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
10. Many Heart Attack Patients Dont Get Best Emergency Treatment
11. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... 2016 TARE (Transarterial Radio-embolization) ... Savings and Overall Decreased Use of Hospital ... international specialist healthcare company, has today announced the ... Meeting of ISPOR (International Society for Pharmacoeconomics and ... (HCC) using yttrium-90 glass microspheres is associated with ...
(Date:5/25/2016)... FDA 510(k) clearance covers ... for urological and surgical applications Mauna ... Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, ... US with the 12 th 510(k) clearance ... This new FDA clearance covers Confocal Miniprobes indicated ...
(Date:5/25/2016)... , Germany and GERMANTOWN, ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime Standard: ... licensing and co-development agreement with Therawis Diagnostics GmbH to develop ... be to develop and market PITX2 as a marker to ... high-risk breast cancer patients. "We are pleased to ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 27, 2016 , ... An educational campaign aimed at everyone ... courtesy of awareness-driven celebrities and thought leaders. It also provides insight to the ... leaders such as Bioness. , As patients feel increasingly concerned about the ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... Aimed at ... human interest stories, which come courtesy of leaders in the nursing and health care ... from leading advocates and associations—namely Abilene Christian University. , As the nursing industry ...
(Date:5/26/2016)... ... May 26, 2016 , ... There are many ways to cook a ... (NHDSC) suggests that Americans prefer their dogs straight off the grill. Of the 90 ... their favorite way to cook a hot dog, far outpacing other cooking methods such ...
(Date:5/26/2016)... Atlanta, Georgia (PRWEB) , ... May 26, 2016 ... ... a certificate in intellectual property (IP) to its specialty academic programs. , Answering ... joins the college’s existing certificate programs in health law, and environmental and land ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... a significant negative impact on long-term patient survival, reports a team of UPMC ... online this week in the Journal of Thoracic and Cardiovascular Surgery, provide critical ...
Breaking Medicine News(10 mins):