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Cardiovascular Business News
THURSDAY, OCTOBER 23, 2008
From the News Editor

Economic crisis hits home
Last week, two major cardiovascular healthcare companies—GE Healthcare and Philips Healthcare—reported losses for the 2008 fiscal third quarter. In unveiling their shaky financials, execs from both vendors cited trouble in the credit markets as a reason for problems they face in the U.S. healthcare sector, as hospitals are finding it difficult to get funding for capital equipment purchases.

This week, more bleak financial news emerged from various cardiovascular device makers and pharmaceutical companies. Merck announced that it was going to cut 7,200 more jobs, in addition to the more than 10,000 positions that were eliminated over the past three years. These layoffs are partly due to the falling sales of their once-popular statins, Zetia and Vytorin, which saw sales drop by 15 percent in the third quarter.

Merck is not the only company affected by the financial crisis: Boston Scientific posted losses as well, enduring slumping stent sales and a Johnson & Johnson settlement, which affected its bottom line. While rising sales for Angiomax helped the Medicines Company to narrow its net losses, soaring research and development costs pushed the pharma company into the red.
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Top Stories
Senate probes TCT over fiscal ties to industry
Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis., have requested that the Cardiovascular Research Foundation (CRF), which sponsors Transcatheter Cardiovascular Therapeutics (TCT), and Columbia University, reveal how medical devicemakers have promoted their products throughout the symposium's sessions.
Merck to cut 7,200 more jobs, partly due to plunging Vytorin, Zetia sales
In conjunction with the release of its third quarter financials on Wednesday, Merck said it plans to eliminate approximately 12 percent of its work force, or 7,200 jobs, by the end of 2011—40 percent of which will occur in the U.S.—as part of its 2008 restructuring initiative.
Study: Medicare P4P penalizes hospitals for caring for neediest MI patients
Medicare's pay-for-performance (P4P) program ranks and rewards hospitals according to how well they meet certain guidelines for clinical care; however, researchers at Duke Clinical Research Institute found that the program penalizes hospitals by not taking into account their greater clinical burden.
Pfizer settles Celebrex, Bextra litigation for nearly $900M
Pfizer has agreed to resolve most of the personal injury cases, consumer fraud cases and state attorneys general claims involving its non-steroidal anti-inflammatory (NSAID) pain medication Bextra, following court rulings in favor of Celebrex. Both were linked to adverse cardiovascular events.

Industry News

Minnesota med school ponders banning all gifts to docs
The University of Minnesota Medical School in Duluth, is considering a new conflict-of-interest policy so strict, that doctors would not even allow Post-it Notes bearing a pharmaceutical company's logo.

No end in sight for FDA prasugrel decision
In response to recent media speculation regarding the status of prasugrel's new drug application (NDA), Daiichi Sankyo and Eli Lilly have reiterated that they are in continued discussions with the FDA and have not been notified of any regulatory action for the NDA, or of any decision to have an advisory committee to review prasugrel.

FEATURE: MIV Therapeutics CEO discusses future of polymer-free DES
WASHINGTON—MIV Therapeutics CEO, Mark Landy, MD, told Cardiovascular Business News that one of the most important findings from the one-year clinical data for the first-in-man VESTASYNC I trial, assessing its VESTAsync polymer-free drug-eluting stent (DES), was that there was statistically no degradation at 12 months. The data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference last week.

Medicaid projected to spend $4.9 trillion over next 10 years
Under current law, spending on Medicaid is expected to substantially outpace the rate of growth in the U.S. economy over the next decade, according to a new annual report released Oct. 17 by the Centers for Medicare & Medicaid Services (CMS).

AHA: Providers need to move quickly into post-cardiac arrest care
The urgent need for treatment does not end when a person regains a pulse after sudden cardiac arrest—healthcare providers need to move quickly into post-cardiac arrest care to keep a person alive and ensure the best outcome, according to American Heart Association (AHA) science advisory published today in Circulation.

NIH grants 1.5M to fund device study for cardiac arrest resuscitation
Advanced Circulatory Systems has received an additional $1.5 million in funding from the National Institutes of Health (NIH) to continue testing two devices used in combination on those who experience cardiac arrest outside a hospital.

Covidien launches $100M plant expansion, adds jobs
Covidien has initiated a $100 million expansion of its St. Louis-based facilities, and will be adding 30 new professional-track jobs, over the next five years.

Surgeon General galvanizes industry for deep vein thrombosis prevention
Acting Surgeon General Steven K. Galson, MD, has issued a 'call to action' to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

Financial News

Boston Scientific losses narrow in Q3; despite falling stent sales
Boston Scientific has reported its financial results for the 2008 third quarter, which ended Sept. 30, as well as its guidance for net sales for the fourth quarter of this year.

Medicines Company sees continued losses for Q3; Angiomax sales increase
The Medicines Company has reported its financial results for the third quarter of 2008, which ended Sept. 30, reflecting mixed results for the pharmaceutical vendor.

Heart valve sales boost Edwards Lifesciences Q3 profits
Edwards Lifesciences has reported an increase in net profit for the third quarter of 2008, which ended Sept. 30, boosted by a 16.1 percent sales growth for the quarter.

Lehman Brothers crisis incites Boston Scientific stock sell-off
The bankruptcy of Lehman Brothers Holdings has taken a toll on Boston Scientific, forcing the founders to sell approximately 13 million shares.

Baxter sees nearly 20% spike in net income
Baxter International has posted strong financial results for the third quarter of this year, which has caused the company to raise its full-year 2008 earnings outlook.

Clinical Studies

CMAJ: Providers should adopt performance measures for acute MI treatment
Implementation of strategies by clinicians and hospitals to meet target benchmarks on these quality indicators could save the lives of many individuals with acute MI, according to a review in the Oct. 21 issue of the Canadian Medical Association Journal.

JAMA: Lessening meds for a-fib prevention appears to worsen outcomes
Reducing the frequency of amiodarone doses in patients did not decrease the overall amount of related side effects and increased the rate of atrial fibrillation recurrence and the risk of death from all causes and cardiovascular hospitalizations, according to a study in the Oct. 15 issue of Journal of the American Medical Association.

AoS: Beta-blockers linked to MI, death when given during non-cardiac surgeries
Some patients who received beta-blockers before and around the time of undergoing non-cardiac surgery appear to have higher rates of heart attack and death within 30 days of their surgery, according to a study in the October issue of Archives of Surgery.

BMJ: Aspirin does not prevent heart attacks in patients with diabetes
Taking regular aspirin and antioxidant supplements does not prevent heart attacks even in high risk groups with diabetes and asymptomatic arterial disease, and aspirin should only be given to patients with established heart disease, stroke or limb arterial disease, according to a study published Oct. 16 in the British Medical Journal.

Mergers & Acquisitions

Largest Wisconsin cardiology group merges into Aurora Health Care
Comprehensive Cardiovascular Care (CCC) Group, the largest cardiology group in Wisconsin and one of the largest in the Midwest, has merged with Aurora Health Care, both of Milwaukee, in a deal that involves 15 interventional cardiologists, nine invasive cardiologists and eight electrophysiologists. The terms of the merger were not disclosed.

NextGen to acquire revenue cycle management firm
NextGen Healthcare Information Systems, a wholly owned subsidiary of Quality Systems and a provider of ambulatory healthcare information systems, has entered into an agreement to acquire Practice Management Partners (PMP), a healthcare revenue cycle management (RCM) company.

Partnerships & Alliances

Philips, King's College London to research heart disease
Royal Philips Electronics has signed a new memorandum of understanding for a five-year cardiovascular imaging research collaboration with King's College London.

Cardima expands into EP market with Biocore partnership
Cardima has established a new strategic surgical relationship with an electrophysiology (EP) sales and marketing contract with Biocore, an Eastern regional sales agent specializing in sales and customer training and support for cardiac devices in the U.S.

Regulatory News

Berlin Heart gets FDA unconditional IDE for pediatric VAD, trial continues
Berlin Heart's Excor Pediatric ventricular assist device (VAD) can be used in an ongoing clinical trial in the U.S., with the FDA's unconditional investigational exemption (IDE) for the device.

Executive Announcements

CoreValve elects Fischer to board
CoreValve has expanded its board of directors by electing Frank Fischer as a new member.

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