September 26, - October 2, 2005

September 30th

Cordis Corporation Acquires Lumend, Inc.

Cordis, a Johnson & Johnson company, recently announced the acquisition of LuMend, a privately held company focused on the development of chronic total occlusion (CTO) devices to treat peripheral vascular disease. A CTO is a complete or partial blockage of an artery that can lead to surgery or lower extremity amputation.

Medtronic Seeks FDA Approval For Spinal Device

Medtronic recently submitted a premarket approval (PMA) application to the FDA for its rhBMP-2 device for posterior lumbar spinal fusion surgery.

The company based its PMA on a randomized, prospective clinical study involving more than 460 patients. The device is a bone morphogenetic protein that stimulates new bone growth or bone regeneration, and is the active component in Medtronic's Infuse Bone Graft. The FDA previously approved its use for anterior lumbar interbody fusion procedures and for certain tibial fractures.

The company says that Infuse will be the only bone graft replacement to receive PMA. More than 250,000 lumbar spinal fusions are performed each year to stabilize the vertebrae and help eliminate pain caused by degenerative disc disease in the spine

GSK: Paxil May Cause Increased Risk Of Birth Defects

A new epidemiologic study of GlaxoSmithKline's (GSK) top-selling antidepressant Paxil suggests the drug may be associated with an increased risk of birth defects compared to other antidepressants, GSK states in a recently issued "Dear Healthcare Professional" letter.

GSK's letter, which was recently posted to the FDA's website, warns that pregnant women exposed to Paxil (paroxetine HCl) or Paxil CR (paroxetine HCl controlled-release tablets) during the first trimester were more than twice as likely to have a child with birth defects than women taking other antidepressants. The warning was based on preliminary data from a GSK-led retrospective epidemiologic study involving nearly 3,600 pregnant women, according to the letter.

September 29th

Heart Devices Market May Reach $25 Billion By 2014

The U.S. market for heart devices is likely to grow by nearly 15 percent over the next 10 years, surpassing the $25 billion mark by 2014, a recent study finds.

According to a Sept. 1 report by Kalorama Information, The U.S. Market for Cardiovascular Devices, devices such as pacemakers, implantable cardioverter-defibrillators and heart stents are increasingly gaining clinical and reimbursement acceptance for a wide range of heart diseases, including congestive heart failure, arrhythmias and heart valve disease.

Boston Scientific Suspends Sales Of Acid Reflux Kit

Boston Scientific has suspended sales of the acid reflux disease treatment Enteryx after more than two-dozen reports of problems because of incorrect use of Enteryx injection kits.

The company's recall notice says that some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing "adverse events." According to reports filed with the FDA, patients have suffered leakage, swelling and ulcers in the esophagus. An elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.

About 3,800 patients have been treated with Enteryx, which was approved in 2003 by the FDA. The treatment is a liquid polymer injected directly into the walls of the esophagus. It thickens into a permanent spongy lump that is supposed to help block acid from flowing from the stomach toward the throat.

Tysabri Submission Includes Label Revisions, Risk Management Plan

Biogen Idec and Elan's plan to revive its withdrawn multiple sclerosis (MS) drug Tysabri includes revisions to the product's label, as well as the establishment of a risk management plan for the drug.

The firms recently announced they had filed a supplemental biologics license application (sBLA) with the FDA, seeking permission to return the drug to the market as a treatment for MS. The filing comes roughly seven months after Biogen and Elan voluntarily suspended marketing and clinical use of Tysabri (natalizumab), following reports that three patients taking the drug in a clinical trial contracted progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal demyelinating disease of the central nervous system.

Although the companies are still negotiating the label changes with the FDA, they indicated that a black box warning for PML would be included in the new label. However, the companies are not expected to remove existing label information regarding Tysabri's use in combination with Biogen's older MS treatment Avonex (interferon beta-1a) — a move that caught some observers by surprise.

September 28th

Medtronic Challenges Stent Licensing Agreement

Medtronic is challenging a FTC recommendation giving Johnson & Johnson permission to grant Abbott Laboratories an exclusive license to a patented system for implanting stents. Medtronic either wants J&J to give it an exclusive license or access to the technology in addition to Abbott.

The system in question, which allows stents to be inserted by a physician without the help of an assistant, is known as rapid-exchange stent delivery.

Medtronic has enlisted doctors to lobby the FTC, urging the agency to allow Medtronic to use the technology in order to remain competitive in the drug-coated stent market — a market that analysts predict will reach $3.5 billion by 2008.

Beth Israel Medical Center Investigating Unique Treatment For Heart Failure

Cardiologists at Beth Israel Medical Center are currently enrolling patients in an investigational study that is looking at the safety and efficacy of a new treatment for moderate to severe heart failure, in which a pacemaker-like device helps strengthen the heart's pumping power. The FIX-HF-5 (Fix Heart Failure 5) study involves a pulse generator, the Optimizer System, that delivers electrical signals to the heart muscle in the midst of its pumping action, "fooling" it into producing more intracellular calcium and thus increasing the heart's ability to pump and contract.

Promising Diagnostic Tools For Multiple Sclerosis Developed At Yale

Yale School of Medicine researchers have identified three rapid diagnostic methods that can target antibodies commonly found in multiple sclerosis patients, greatly improving potential diagnosis and treatment. The team reports their findings in this week's Proceedings of the National Academies of Science.

September 27th

Study Finds Way To Prevent Device-Related Infections

A new type of chemical bond between antibiotics and titanium, a material used in devices, may be the first step toward eliminating device-related infections, according to a recent report in the journal Chemistry and Biology.

Researchers at Jefferson Medical College in Philadelphia found that by fastening the antibiotic vancomycin to titanium powder they were able to immediately kill bacteria sensitive to the antibiotic. The scientists developed a bonding method to ensure that the antibiotic stays attached to metal.

Infections associated with orthopedic implants are one of the major causes of implant failure because when bacteria grow on an implant it cannot knit properly with the bone. "The biggest benefit of this work is to keep the infection from ever starting," Eric Wickstrom, one of the developers of the bonding method, says.

Prices For Brand Drugs Increasing Faster Than Those For Generics, Says GAO

Retail prices for frequently used brand drugs have increased roughly three times faster than those of commonly used generic drugs, according to a Government Accountability Office (GAO) report, which predicts public and private insurers will turn to generics to reduce costs.

"With brand drug prices increasing three times as fast as generic drug prices, public and private health insurance sponsors will likely continue to focus on strategies to encourage increased use of generic drugs when available," says the report, requested by Sens. Olympia Snowe (R-Maine) and Ron Wyden (D-Ore.).

From January 2000-December 2004, the average retail price paid by patients without prescription drug coverage for 96 frequently used drugs increased 24.5 percent. Twenty drugs — 19 brand and one generic — accounted for 64 percent of the total retail price increase, the report shows.

September 26th

FDA Approves Early End To Study Of Essure Birth Control Procedure

The FDA recently approved early termination of a postapproval study of Conceptus' Essure birth control procedure because of the positive data obtained so far. The purpose of the study was to determine the success rate in placing the device. The Essure procedure deploys a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to block the fallopian tube.

Although the treatment of the number of patients usually required by the FDA has not been completed, the positive results thus far convinced the agency to end the study. The FDA's decision moves the agency one step closer to approving a supplemental label for bilateral placement rates.

Crawford Steps Down As FDA Chief

FDA Commissioner Lester Crawford stunned the industry with the announcement late Friday that he was stepping down from the post he had fought to gain just two months before. Crawford, 67, whose nomination was delayed by an anonymous allegation of personal misconduct and political opposition to the agency's decision not to approve the Plan B contraceptive, gave no specific reason for his resignation. He was confirmed by the Senate on July 18, after having served as acting commissioner and deputy commissioner. The White House reportedly named Andrew von Eschenbach, the head of the National Cancer Institute, as acting commissioner.

FDA Issues Proposed Rule On cGMPs For PET Drugs

The FDA has issued a proposed rule on current good manufacturing practices (cGMPs) for positron emission tomography (PET) drugs.

The proposed rule will establish minimum standards for the production and testing of PET drugs, the FDA said. The agency has also concurrently published a draft guidance, titled "PET Drug Products — Current Good Manufacturing Practice." The guidance describes acceptable approaches for PET drug producers to meet the requirements of the proposed regulation.

PET is a medical diagnostic tool in which a radioactive drug is administered to a patient, most commonly by intravenous injection, and the distribution and uptake of the radioactive drug to various bodily organs is imaged using a scanner. The image helps physicians diagnose diseases such as cancer and heart disease.