October 10, - October 16, 2005

October 14th:

FDA Seizes Baxter's Infusion, Syringe Pumps

The FDA has seized roughly 6,000 infusion pumps and 850 syringe pumps manufactured by Baxter Healthcare.

The seizure involved Baxter's Colleague Volumetric Infusion Pumps and Syndeo PCA Syringe Pumps, which were being held at two facilities in Illinois. Baxter had placed a voluntary hold on shipments of the products earlier this year after batter problems were discovered, the firm said.

The FDA's latest action affects only Baxter's inventory, and not the customer-owned pumps currently being serviced by Baxter, the firm said. Baxter also said it is unable to provide loaner pumps to customers who have removed pumps from service. The company, however, reiterated the fact that it has developed an aggressive corrective action plan for the products, and remains in discussions with the FDA.

Roughly 250,000 Colleague infusion pumps are in use worldwide, including more than 200,000 in the U.S., Baxter said. There are approximately 5,000 Syndeo pumps in use worldwide.

Medtronic Introduces CD HORIZON SPIRE(TM) Spinal System

Medtronic, Inc. announced the U.S. market availability of CD HORIZON SPIRE(TM) Spinal System for use in spinal surgery. This minimally invasive product allows surgeons to fixate the spine by attaching a plate to the spinous process of the vertebral body during spinal fusion surgery as a supplement to the CD HORIZON® Rod and Screw System. The announcement was made today during the Congress of Neurological Surgeons meeting in Boston.

The CD HORIZON SPIRE Spinal System can provide surgeons with an easy and rapid insertion without fluoroscopy. Its use can potentially minimize soft tissue disruption.

Report by GAO Blasts FDA'S PLAN B Decision making

An unreleased federal report bolsters allegations that the FDA made a political rather than a scientific decision when it delayed Barr Pharmaceuticals' application to sell the Plan B contraceptive without a prescription, congressional sources say.

The Government Accountability Office's (GAO) initial report on the FDA's handling of Plan B (levonorgestrel) shows the agency took numerous unprecedented steps to inject politics into its decision, according to congressional staff who have reviewed the GAO's findings. While the report will not be publicly available until November, the document was on display for lawmakers and their staff beginning Oct. 12. Staffers say the GAO didn't distribute copies of its preliminary findings due to the "sensitivity" of the subject.

The GAO concluded the FDA took authority for the Plan B decision away from the staffers that usually make such decisions, made an initial decision to reject the application before internal and external reviews were completed, and delayed its decision to consider issues such as adolescent promiscuity, one Hill staffer said.

October 13th:

Supreme Court Rejects Claim against Medtronic

The U.S. Supreme Court has refused to hear a claim against Medtronic alleging the company produced faulty devices, ensuring manufacturers liability protection for devices that have been approved by the FDA.

The Court's denial of a request for review leaves intact a lower court ruling that Medtronic was not liable for faulty leads in its pacemakers. The company had pulled its 4004 and 4004M leads from the market because of concerns that the polyurethane insulation would degrade. But the company did not ask doctors to remove leads that had already been implanted in patients.

Fourteen patients challenged this practice, alleging negligence. Of those patients, 12 needed additional heart surgeries to replace the leads and two had theirs capped.

The rejection marks the third time in five years that the high court has refused to intercede on behalf of patients seeking to sue Medtronic. Lower courts have generally rejected such claims.

More Experienced Doctors Equal More Successful ICD Implants

Patients who have implantable cardioverter-defibrillators (ICDs) implanted by more experienced physicians are less likely to have complications, a recent study finds.

A report published in the Oct. 18 issue of the Journal of the American College of Cardiology found that patients using doctors with less experience installing ICDs are more likely to suffer from infections and mechanical complications. The report is the result of the largest study of the relationship between the volume of ICD procedures done and the outcome for patients.

The researchers analyzed Medicare records for 1999 through 2001 to determine how many patients receiving ICDs received hospital care for complications within 90 days of the procedures. Medical complications were more common among patients using less experienced doctors. Physicians who implanted at least 11 ICDs per year had lower levels of both mechanical complications and infections, the report found.

Enrollment in Stroke Treatment Trial Halted Amid Safety Concerns

Eli Lilly and Centocor have temporarily suspended enrollment in a late-stage clinical trial of their heart treatment ReoPro after a review of preliminary trial data revealed a potential safety problem with the drug.

The Phase III trial, which is examining ReoPro (abciximab) as a potential treatment for acute ischemic stroke, was stopped after the study's independent safety and efficacy monitoring committee (SEMC) observed a safety concern in the trial data. Lilly and Centocor didn't reveal details about the safety concern.

The SEMC is in the process of evaluating the entire risk-benefit profile of ReoPro for acute ischemic stroke patients before coming to a final recommendation on whether or not enrollment in the trial should resume. Patients currently enrolled in the trial will not receive additional doses of ReoPro and data for these patients will be reviewed before the SEMC provides its recommendation on how to proceed with the Abciximab in Emergent Stroke Treatment Trial-II (AbESTT-II).

October 12th:

FDA Issues Guidance for Reprocessor's Mark on SUDS

Manufacturers that reprocess single-use devices (SUDs) must attach to the products a prominent and conspicuous mark identifying the firm's name or recognized symbol, according to a new FDA draft guidance that offers practical suggestions on what is necessary for a corporate identifier to be recognized during ordinary use.

A manufacturer's mark will be considered prominent and conspicuous based on four factors: available space, contrast, font or graphic readability and meaning, says the guidance, published Oct. 11 in the Federal Register.

Under the 2005 Medical Device User Fee Stabilization Act (MDUFSA), the labeling provision on corporate marks, which previously applied to all manufacturers, was limited to reprocessed SUDs and the manufacturers who reprocess them, the guidance says. The change also applies to original equipment manufacturers that reprocess SUDs.

Panel Meeting to Center on Postmarketing Commitments

The FDA will call on its Oncologic Drugs Advisory Committee next month to provide recommendations on how drugmakers can better meet postmarketing commitments for drugs cleared under the accelerated approval process.

The advisory panel will meet Nov. 8 to "identify difficulties associated with completion of Phase IV commitments" and "provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs," the FDA said. The meeting will take place in Gaithersburg , Md.

October 11th:

FDA May Recall St. Jude Defibrillators

The FDA may issue a recall of older St. Jude Medical implantable cardioverter defibrillators (ICDs) after the company reported that background levels of radiation in the atmosphere might cause the devices to suddenly lose power.

St. Jude Medical recently announced that in 60 of the 36,000 Photon DR, Photon Micro VR/DR and Atlas VR/DR devices, exposure to cosmic radiation affected the ICD's memory. But the company said that no serious patient injuries or deaths have been reported because of the flaw.

In its recent physician advisory, St. Jude Medical recommended that doctors should perform routine device monitoring every three months for patients with these ICDs. The company is also offering a remote monitoring product, Housecall Plus, at no charge. "St. Jude Medical has taken a conservative, proactive approach in notifying the medical community of this anomaly," said Mark Carlson, a member of an independent panel that reviewed the issue for the company.

Medtronic Submits First PMA for Its Heart Stent

Medtronic recently submitted its first pre-market approval (PMA) module to the FDA for its Endeavor drug-eluting heart stent. The PMA represents the company's first step to get U.S. approval for the device, Medtronic said.

The Endeavor stent is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability over bare metal stents. The stent is coated with the proprietary drug compound ABT-578 and phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane. Medtronic received European approval for the stent in July.

Survey: Most Physicians Support Ad Moratorium for New Drugs

More than 80 percent of physicians believe a moratorium should be placed on direct-to-consumer (DTC) advertising immediately following the approval of a new drug, according to a survey conducted by HRA Research.

Of the 2,015 doctors participating in the Internet survey, 81 percent responded that DTC advertising should be prohibited for new prescription drugs for a period of time after FDA approval to allow physicians to familiarize themselves with new products. The survey included both office- and hospital-based physicians from virtually all practice areas.

While the large majority of physicians favored some type of moratorium on DTC ads, there was less agreement about the type of ban that should be implemented. Forty-three percent of survey participants favored a mandatory ban for some limited period of time, 33 percent recommended a voluntary ban with each pharmaceutical company deciding when to begin advertising to consumers, and 24 percent said it is not necessary to place either type of ban on DTC advertising.

October 10th:

Guidant Launches Heart Stent System in Japan

Guidant recently launched its Multi-Link Vision RX Coronary Stent System in Japan after receiving the Japanese government's regulatory and reimbursement approvals. This new stent system uses cobalt chromium, which is stronger and more radiopaque than stainless steel, allowing these devices to be thinner without compromising visibility, the company said.

Japan's Ministry of Health, Labor and Welfare recently approved the device in coronary vessels, in 8 mm to 28 mm lengths. The system has demonstrated positive clinical results, with a 1.9 percent target lesion revascularization and a 15.7 percent binary restenosis rate at six months.

"The MULTI-LINK VISION RX offers excellent clinical results for the treatment of coronary artery disease," noted Greg Davis, president of Guidant, Japan K.K.

Military to Fund Prosthetics Research

The Department of Defense is beginning a multimillion dollar research program to improve upper-body prosthetics, prompted by the large number of troops who have lost hands and arms in the Iraq and Afghanistan wars, USA Today reported.

Over the next four years, the Pentagon will spend nearly $35 million to develop improved artificial arms, which perform more like a real arm. The device would be guided by the central nervous system.

The investment is the largest pool of funding for prosthetics in at least a decade, a spokeswoman for the Defense Advanced Research Projects Agency said. That office will award the research contracts.