The Crux retrievable inferior vena cava filter (VCF) represents the first significant innovation in vena cava filters in 40 years. Crux Biomedical designed the device to overcome problems associated with retrievable VCFs, including tilting of the filter, device migration, fracturing, and retrieval difficulties.
A recent short film titled “Heart Stop Beating” made by Jeremiah Zagar provides a glimpse into the development of the technology and its use to save the life of Craig Lewis, a 55-year-old man dying from amyloidosis.
According to data from the World Health Organization, an estimated 15 million people suffer strokes worldwide annually. Approximately 80% stroke survivors have difficulty with arm movement, says Stephen Page, PhD, FAHA, an occupational therapist at the Ohio State University Medical Center.
French research organization CEA-Leti is spearheading the development of a pacemaker that is eight times smaller than contemporary models. The product of the Heart-Beat Scavenger (HBS) Consortium, which also includes Sorin Group, TIMA, Cedrat Technologies, Tronics, and EASII IC, the device harvests mechanical energy directly from the heart, which enables the pacemaker to forego the need for batteries and the surgeries required to change periodically change them.
Infections associated with pacemakers and defibrillators were the subject of a study involving Medicare beneficiaries conducted by the Mayo Clinic, The Johns Hopkins School of Medicine, and TYRX Inc. TYRX , a company specializing in site-specific infections for implantable devices, provided financial support for the study.
Here’s one that’s very close to my heart, speaking figuratively, not literally. A new pacemaker, developed by Medtronic, allows patients with the device to undergo MRIs, thanks to an approval last month by the FDA.
Medtronic, which recently made the news because of its recent job cuts , is developing a miniature, injectable pacemaker that could be ready for market introduction within five years. The device, which is roughly the size of a Tic Tac, could be inserted into the heart using a technique similar to cardiac catheterization. The pacemaker would be substantially smaller than currently available pacemakers, which are generally about the size of a silver dollar.
Some would argue that women have enough difficulties without being slighted in healthcare. But that's what Rita F. Redberg, a professor of medicine and director of Women's Cardiovascular Services at UC San Francisco and a member of the FDA Circulatory System Devices Panel, contends in a new report.
CDRH has decided to intervene with external defibrillator problems and recalls that have increased over the past few years. Letters to defibrillator manufacturers were sent in November advising them that FDA “may, in the future, take regulatory steps to improve the current premarket and postmarket regulatory processes associated with external defibrillators.”
Around the world, millions die because they can't afford pacemakers. In the latest issue of Circulation , experts from the University of Michigan Cardiovascular Center discuss the legality and logistics of recycling pacemakers. In other words, these devices could be collected after they are removed for burial or cremation, sterilized, and then reused.
Medical filters used to prevent blood clots should be removed from the body as soon as the clot risk has passed, says an advisory report from FDA. The warning comes because of 900 reports about problems with these filters collected since 2005. Problems can arise when filters are left inside veins too long. The devices can shift, and pieces can break off, drift through the bloodstream and perforate vital organs including the heart, according to adverse event reports.
Covidien Plc , the medical-equipment company spun off from Tyco International Ltd., agreed to buy ev3 Inc. (Plymouth, MI) for $2.6 billion. Covidien will pay $22.50 a share in cash for ev3. Dublin-based Covidien is paying 19% more than the May 28 closing price for ev3’s stock.
FDA is allowing Boston Scientific to resume defibrillator sales. Sales were halted due to manufacturing process changes that had not been approved by the agency. Both the company and FDA say that the changes did not affect the safety of the defibrillators, which send electrical jolts to the heart to regulate heartbeat.
The foremost topic on the mind of manufacturers in any industry is the state of the economy. Historic unemployment rates, a lending crisis, and overall uncertainty for the future have cut into consumer spending. Even in the robust medical device sector, industry participants see the ramifications.