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From the News Editor
Live from TCT
The news from this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C., revealed the truth in the words of Jonathan Swift to the interventional community: There is nothing constant in this world but inconsistency.
Dr. Martin B. Leon, chairman emeritus of the Cardiovascular Research Foundation (CRF), which sponsors TCT, reported that the utilization of DES has experienced a 1.3 percent increase for PCI this year in the Drug-Eluting Stent (DES) Summit. This may represent a “soft rebound” from the 10 percent drop that stenting endured in 2007. However, he also noted that the CABG experienced 22 percent increase for 2008. Based on these figures, physicians are slowly beginning to readopt PCI as a treatment option, but are still hesitant about widespread utilization.
The initial results of the Boston Scientific SYNTAX study, which were presented at the European Society of Cardiology (ESC), indicated that CABG was preferable to stenting in the sickest patient populations. However, new subgroup analysis from SYNTAX presented this week showed equivalent safety and efficacy endpoints between PCI and CABG amongst patients with unprotected left main disease, and showed improved efficacy outcomes in triple-vessel disease. Read more > |
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HORIZONS AMI finds DES more effective, as safe as BMS at one year
WASHINGTON—After one year, use of a drug-eluting stent (DES) in heart attack patients demonstrated significantly reduced rates of target lesion revascularization (TLR) and binary angiographic restenosis when compared to the use of a bare metal stent (BMS), according to the HORIZONS AMI trial presented Wednesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. |
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Stent makers, big pharma tackle $100M dual-antiplatelet therapy trial
Four pharmaceutical companies and four stent manufacturers have agreed to launch a $100 million, 20,000-patient drug-eluting stent (DES) study, the Dual Antiplatelet Therapy (DAPT) trial. |
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JAMA: Doctors are skipping stress tests prior to elective PCI
Researchers have found that Medicare recipients who undergo elective PCI often do not get the recommended stress tests to confirm the surgery is warranted, according to a study published in the Oct. 15 issue of the Journal of the American Medical Association. |
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Government probes FDA actions in Actavis recalls
The House Energy and Commerce Committee is investigating alleged FDA shortcomings to request more information about Actavis recalls, including withdrawal of all products from its Little Falls, N.J. plant. |
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TCT Conference News
HORIZONS AMI data will likely lead to wider bivalirudin usage in acute MI
WASHINGTON—After one year, use of bivalirudin in MI patients, who receive angioplasty, resulted in significantly lower rates of all-cause death, death from cardiac causes, and major bleeding, compared to the standard drug therapy of heparin and glycoprotein IIb/IIIa inhibitors, according to the HORIZONS AMI trial presented Wednesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Cardiothoracic surgeons look to reinvention in age of minimally invasive procedures
WASHINGTON—In no uncertain terms, W. Randolph Chitwood Jr., MD, told an audience heavily populated with cardiac surgeons that “we must reinvent ourselves.”
Proxis embolic protection system could be efficacious in the PCI setting
WASHINGTON—The Proxis embolic protection system is feasible and safe in the setting of STEMI, and effectively retrieves embolic debris in most patients, according to the late breaking clinical PREPARE trial presented Wednesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Industry News
Imaging economics may ultimately drive U.S. CCTA policy
PHOENIX–Although recent technological advances in multi-detector CT have refined the capabilities of the modality to perform cardiac CT angiography (CCTA), larger economic issues surrounding the utilization of diagnostic imaging may yet impact reimbursement approval for the exam, according to a presentation this weekend at the 2008 North American Society for Cardiovascular Imaging (NASCI) annual meeting.
Cardiac Science alerts users to faulty defibrillator software
Cardiac Science initiated a global voluntary field corrective action on Monday for certain automated external defibrillators (AEDs) manufactured between August 2006 and March 2007.
Study: Death rate 70 percent lower at top-rated hospitals
Patients have a 70 percent lower chance of dying at U.S. top-rated hospitals on average, compared with the lowest-rated hospitals, according to results from the eleventh annual HealthGrades Hospital Quality in America study, issued Tuesday by HealthGrades, an independent healthcare ratings organization.
Edwards loses heart valve patent suit against CoreValve in Germany
The District Court of Düsseldorf, Germany, has rejected Edwards Lifesciences’ assertion that CoreValve is infringing Edwards’ German Anderson patent for a transcatheter heart valve technology.
FDA draft guidance targets timely regulation, labeling for imaging drugs, devices
The FDA is seeking public comment on a draft guidance for medical imaging devices with contrast agents or radiopharmaceuticals that focuses on developing new contrast indications for imaging device use with already approved imaging products.
Volcano relocates headquarters
Volcano, a developer of intravascular ultrasound, has moved its corporate headquarters from Northern California's Rancho Cordova to San Diego.
Financial News
GE Healthcare sees challenging Q3
GE reported a 22 percent decline in profit overall, and its Healthcare unit, now a part of the Technology Infrastructure segment, posted an 8 percent decline in profit for the company’s 2008 third quarter financial results.
Strong stent sales lead Abbott to Q3 double-digit gains
Abbott Laboratories reported a 51 percent rise in third-quarter profit, citing double-digit sales increases for its pharmaceutical, medical device and nutritional product lines.
Philips Q3 profit falls, despite higher revenues
Philips Healthcare reported a 5 percent increase in sales in its 2008 third quarter, however, it posted sharply lower third-quarter profit that missed forecasts, which the company said is partly due to the credit crisis in the United States.
Clinical Studies
AJC: Florida needs to develop a regional network for STEMI care
Women, the elderly and patients admitted to the emergency department (ED) on weekends, are all less likely to receive same-day coronary angioplasty for a life-threatening heart attack in Florida, according to a study in the Oct. 1 issue of the American Journal of Cardiology.
Lancet: Vioxx substantially increases risk of stroke, MI and death
Long term follow-up data confirms that use of the Cox-2 inhibitor rofecoxib (Vioxx) substantially increases the risk of stroke, heart attack and death compared with placebo, according to conclusions from the APPROVe trial, which were published online ahead of print in the Lancet.
New Products
TyRx new ICD features target surgical site infections
TyRx, a provider of convergent drug-device medical products, has launched its Aigisrx ICD, an anti-bacterial envelope designed to stabilize the implanted device and help provide protection against surgical site infections (SSI) associated with implantable cardioverter defibrillators (ICDs).
Regulatory News
St. Jude nets FDA, CE Mark clearance for new vascular closure device
WASHINGTON—St. Jude Medical has received FDA and European CE Mark approval of the Angio-Seal Evolution vascular closure device. The approval and global launch were announced this week at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
FDA needs more time to review Takeda combination diabetes drug
Takeda Global Research and Development Center, a wholly owned U.S. subsidiary of Takeda Pharmaceutical, has been notified that the FDA will not be able to complete its review of the alogliptin new drug application (NDA) by Oct. 27.
Mergers & Acquisitions
Emageon to be acquired for $62M; CEO blames proxy settlement
Health Systems Solutions (HHS) has signed a definitive agreement to acquire 100 percent of Emageon’s stock, in an all cash transaction of approximately $62 million.
Partnerships & Alliances
Medmatics anticoagulation software links with Google Chrome
Medmatics, an anticoagulation software company, has partnered with Google to link its software to Google’s Chrome Browser, a new open-source browser.
Executive Announcements
Cordis makes a few exec changes
Cordis, a subsidiary of Johnson & Johnson, has appointed three new senior-level executives. |
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