Physicians may soon have a means for earlier identification of patients who may be at risk for heart attack, through evaluation of what is now believed to be a key contributor to the problem, vulnerable plaque. Abbott Laboratories (Abbott Park, Illinois) reported completion of enrollment in the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study designed to increase clinical understanding of vulnerable plaque — a lipid-rich coronary plaque that suddenly ruptures — believed to be a key culprit in producing myocardial infarction.

The cause of most heart attacks was once believed to be the gradual closing of arteries over time as plaque build-up slowly increased, restricting blood and oxygen flow to the heart. However, the vast majority of heart attacks are now believed to be triggered by the rupture of a lipid-rich vulnerable plaque hidden under a thin fibrous cap on the artery wall, causing blood to clot on the plaque and suddenly blocking the artery, according to a statement from Abbott.

For this reason, heart attacks often occur in apparently healthy people who were unaware they have this type of plaque buildup in the walls of their arteries. It has been found that treadmill stress tests, given to help determine whether blood supply is reduced in the arteries that supply the heart, do not indicate whether vulnerable plaque is present. Additionally, vulnerable plaques are not readily evident in angiograms, either, as the hidden plaque may not yet block the vessel.

PROSPECT enrolled 700 acute coronary syndrome patients receiving stents in the U.S. and Europe. Patients will be followed up for at least two years and up to five years.

The study will use novel intravascular imaging technology, including a virtual histology system developed by Volcano Therapeutics (Rancho Cordova, California), to correlate plaque characteristics, patient risk factors and biomarker measurements with subsequent heart attacks and other cardiac events, potentially paving the way for physicians to identify and treat at-risk patients before a heart attack occurs.

The study is being sponsored by Abbott and implemented via the company’s Abbott Vascular (Redwood City, California) division. The vulnerable plaque program was acquired through Abbott’s $6.4 billion acquisition of the Vascular Intervention and Endovascular Solutions businesses of Guidant (Indianapolis) in April.

“As the first prospective natural history study examining whether novel blood and imaging tests are able to identify patients at risk for future death and heart attack, PROSPECT promises to provide groundbreaking data critical to understanding the progression of coronary artery disease, and represents the first step toward identifying patients at high risk who may benefit from preventative therapies,” said Gregg Stone, MD, professor of medicine at Columbia University Medical Center and principal investigator of the PROSPECT study during a conference call sponsored by the company to discuss the completion of the trial enrollment.

“We need then to figure out strategies to captivate the vulnerable plaque, reduce the likelihood of the vulnerable plaque either developing further or rupturing,” said Stone. “The PROSPECT trial is really the first step to trying to identify patients and lesions which are vulnerable and are likely to cause sudden death, heart attacks and threaten heart attacks. This is really a brave new world and new territory which has never been explored before,” he added.

According to Jeff Ellis, PhD, a research advisor for the company’s vulnerable plaque program, the goal of Abbott “is to work with physicians to help them advance from treatment of a patient’s symptoms to prevention of future heart attacks.”

Ellis used the analogy of the way cancer once was treated in contrast to current therapeutic approach to illustrate how heart attack risk is addressed today vs. how far it has to go to become more useful.

He noted that 20 years ago, many people died of cancer because there was no efficient way to detect it at its earliest stages. Now, he said, a variety of diagnostic tests are available to identify cancers at those early stages as well as better ways to treat these patients once diagnosed.

Stone will present baseline demographic and imaging data from the first group of patients enrolled in PROSPECT in October at the 18th Annual Scientific Symposium, Transcatheter Cardiovascular Therapeutics (TCT 2006) in Washington.

St. Jude consolidating cardio units

St. Jude Medical (St. Paul, Minnesota) reported that it is combining its Cardiac Surgery and Cardiology divisions to create a new Cardiovascular division, effective Jan. 1. The company said the new division will focus on developing medical device technology and services to help patients who suffer from vascular disease or structural heart defects. It will incorporate the activities currently managed by the Cardiac Surgery and Cardiology divisions, although the company will continue to have specialized cardiac surgery and cardiology sales forces.

Company spokesperson Angela Craig told Cardiovascular Device Update that as a result of the consolidation, the company has determined that 30 employee positions represented redundancies between the two divisions and consequently, those positions would “regrettably” have to be eliminated, and some employees would be given added responsibilities. She noted that the affected jobs were “senior administrative positions.”

“This strategic reorganization is another example of St. Jude Medical’s commitment to continuous improvement and to focusing on the needs of our customers,” said Daniel Starks, chairman, president and CEO, in a statement. “Our cardiology and cardiac surgery businesses will be stronger together than each business is separately. By streamlining our organization, we can boost operating efficiencies and ultimately use the associated savings to invest in research and development. This in turn is expected to strengthen our competitive position and improve St. Jude Medical’s total growth profile both in cardiology and in cardiac surgery to benefit our customers, employees, and shareholders.”

Starks said that the creation of the new division, coupled with the expansion of the two units’ respective sales forces and recent product introductions, are part of a comprehensive program to position St. Jude Medical “to deliver a minimum 15% growth in 2007 and beyond.” Craig noted that the two divisions have offices in the St. Paul area and that the company plans on retaining both of the offices, at least in the near term.

The Cardiovascular division will be led by George Fazio, who has served as president of the company’s Cardiac Surgery division since 2004. Prior to his current role, Fazio was appointed president of St. Jude Medical Europe in 2001. His preceding roles included president, healthcare services, and general manager for the company’s operations in Canada.

Paul Buckman, currently president of the Cardiology division, will become corporate vice president of business development. Since joining St. Jude Medical in 2004 in his current role, Buckman has overseen a significant expansion of the Cardiology Division’s products and programs.

In addition, the company is initiating several changes to enhance the efficiency and effectiveness of its sales and customer service operations in certain international geographies.

As a result of these restructuring plans, the company said it expects to incur a pre-tax charge of $25 million to $35 million in 3Q06.

Prudential Equity Group (New York) senior med-tech analyst Larry Biegelsen wrote in a research note that the restructuring will reduce annual selling, general and administrative expenses by an estimated $6 million, or 1 cent a share. While he termed the restructuring a positive development, Biegelsen said that “spending requirements to reaccelerate ICD [implantable cardioverter-defibrillator] sales growth will limit earnings growth.”

Final SEC settlement with Biopure

Blood substitute/oxygen therapeutic developer Biopure (Cambridge, Massachusetts) reported Securities and Exchange final approval to a previously disclosed agreement concerning disclosures the company made in 2003. The company consented, without admitting or denying the allegations, to an injunction against future violations of federal securities laws and regulations, and the settlement requires no payments from the company. Biopure also agreed to adopt the recommendation to retain an independent consultant who will review the company’s future disclosures.

The SEC also gave final approval to a separate settlement agreement with the company’s general counsel, Jane Kober, in a previously-filed action alleging misleading public statements about the company’s efforts to obtain FDA approval for its primary product, Hemopure. The judgment permanently enjoins Kober from aiding violations of the reporting provisions of securities laws and orders her to pay a $40,000 civil penalty.

The settlement with the company consisted of a consent, without admitting or denying any allegations, to an injunction against aiding or abetting violations of certain non-intent-based reporting requirements, payment of a civil penalty, and dismissal by the SEC of all other allegations in the complaint.

These agreements conclude the investigation and litigation, the company said. “This settlement removes a cloud over the company,” said Biopure chairman/
CEO Zafiris Zafirelis. “I am pleased to put this issue behind us as we focus on the development of our oxygen therapeutics.”

The original complaint alleged that, beginning in April 2003, Biopure received negative information from the FDA regarding its efforts to obtain approval of its synthetic blood substitute Hemopure but failed to disclose the information or described it as positive.

In April 2003, the FDA placed a clinical hold barring the company from conducting clinical trials of Hemopure on human trauma victims in hospitals because of safety concerns. However, over the next eight months, the company failed to disclose what the SEC termed “information concerning a clinical hold while making public statements about its plans to obtain approval for trauma uses.”

Then in July 2003 the FDA informed Biopure that it had not approved its application for use of Hemopure in orthopedic surgery, citing deficiencies in its application and concerns about safety and efficacy. Biopure then issued public statements and SEC filings beginning on Aug. 1, 2003, describing the FDA communication as good news, boosting its stock price by more than 20%. But the company continued to make misleading statements until December 2003 while raising more than $35 million, the SEC said.

“As the true status of Biopure’s efforts to obtain FDA approval became public, the company’s stock price plummeted nearly 66% from its Aug. 1 price.” In April, the SEC filed a civil injunctive action against Carl Rausch, former vice chairman of the board and senior technology officer of Biopure, for his role in misleading statements about the company’s efforts to obtain FDA approval for Hemopure. Rausch was charged with abetting misleading statements by the company between April and December 2003. Rausch consented to the entry of a final judgment enjoining him from violating federal securities laws and ordering him to pay a $40,000 penalty.

The SEC previously filed a civil injunctive action on Sept. 14, 2005, against Biopure and three other executives, including Kober, for their roles in this matter.

Northfield puts $100M on shelf

Northfield Laboratories (Evanston, Illinois) has filed a shelf registration statement with the Securities and Exchange Commission, enabling the company to offer and sell up to $100 million of its securities. The terms of any such future offerings would be established at the time of the offering.

Northfield Laboratories is developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. PolyHeme is a solution of chemically modified human hemoglobin that requires no cross matching and is therefore compatible with all blood types. It has a shelf life in excess of 12 months.

Cleveland Clinic, AATS to hold summit

The Cleveland Clinic Kaufman Center for Heart Failure (Cleveland) and the American Association for Thoracic Surgery (Beverly, Massachusetts) will host a national summit on heart failure at the InterContinental Hotel & MBNA Conference Center Cleveland, Oct. 20-22.

The Summit, "21st Century of Heart Failure: Synchronizing Surgical and Medical Therapies for Better Outcomes," could draw more than 450 physicians and researchers to discuss the latest treatments for end-stage heart failure.

Among the topics discussed at the summit will be the epidemiology and pathophysiology of heart failure, recent drug trials for advanced heart failure and innovative assist device technologies for mechanical circulatory support, including the total artificial heart and rotary blood pumps. Strategies for the use of left ventricular assist devices, such as recovery, permanent replacement and bridge to heart transplantation, will also be addressed. Surgical experts will discuss the role of conventional surgery for heart failure, including coronary artery bypass grafts and mitral and aortic valve repair and replacement.

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