BREFnet.org: News

Zimmer Durom Cup video

Wed, 10 Jun 2009 00:00:00 -0400

An article with a link to the video can be found
here.

Zimmer Buys Abbott Spine

Mon, 24 Nov 2008 00:00:00 -0500

This article is of interest to the spinal fusion/ implant device market. Both Zimmer and Abbott are major Orthopedic Implant Manufacturers.

InVivio article.

Medtronic Probe

Wed, 19 Nov 2008 00:00:00 -0500

"A number of patients say they have been harmed in off-label uses of Infuse, which is approved by the FDA only for a small section of the spine in the lower, lumbar region. At least 280 reports of side effects involving Infuse have been made to the FDA. About three-quarters of those reports involve off-label use. In July, the agency issued a safety alert about complications from the off-label use of Infuse in the neck, or cervical, area of the spine."

read the full article in the wall street journal or in the associated press: AP.

Thoratec Heart Pump: Recall HeartMate II.

Tue, 28 Oct 2008 00:00:00 -0400

This Thoratec pump has been approved by the FDA just last April and implanted in 1,973 people. Patients with the device should have it examined.

Read the story: Bloomberg

Catheter Recall

Fri, 03 Oct 2008 00:00:00 -0400

Medtronic has sold some 25,000 catheters of the type discussed in the recall, said spokeswoman Cindy Resman.

Medtronic's drug pumps are implanted in the abdomen and deliver medication through a catheter to the intrathecal space in the spine, the area that surrounds the spinal cord.

article

FDA Brochure on Pediatric Implants

Wed, 17 Sep 2008 00:00:00 -0400

The new handout lists factors to consider, safety concerns, and lists examples of devices commonly implanted in children. The handout can be found at the FDA website here

Stenting vs Bypass results from SYNTAX

Tue, 02 Sep 2008 00:00:00 -0400

The primary endpoints of the study were major adverse cardiac and cerebrovascular events. CABG out performed the Taxus stents. The average number of stents placed in patients was 4.6 inside 3.6 lesions.

For more results:

ACC article: The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery.

UK Registry shows problems with new joints

Tue, 02 Sep 2008 00:00:00 -0400

Almost twice as many patients (2.8 %) receiving unicompartmental knee replacement had to have revision surgery in 3 years. 1.4% of patients with traditional total knee replacement needed revision. Similarly, hip resurfacing was not as long lasting as replacement.

For more information:
Telegraph article