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Clinical and Industry News
Syntervention Releases First Commercial Product, the SWIPER™ Medical Device Foam Wiper, Designed to Eliminate Foreign Body Contamination Found With Use of Cotton Gauze
Data confirms that foreign body contamination is associated with complications and risks that increase liability and costs to the hospital.
Syntervention, Inc. has initiated distribution of the Swiper™ Medical Device Foam Wiper, a sterile, biocompatible, fiber free foam wiper designed for the removal of blood, contrast and other contaminants from sterile instruments and medical devices.
“Physicians have been using cotton gauze in interventional procedures because we never had a good alternative. When we first used the Swiper, we realized that this product is meeting a significant need and could reduce risks to the patient.” said Dr. John Laird, University of California, Davis.
The Swiper uses a fiber-free, low particulate material originally developed and adopted by the National Aeronautics and Space Administration (NASA) and the medical device industry. Gauze-based sponges and non-adherent pads, the most common products used today, contain significantly more fiber and particulate than the Swipe. (Data on file at Syntervention and online at www.syntervention.com.)
“In my personal experience with interventional procedures, I’ve witnessed a number of hazards created by gauze fibers adhering to medical devices and being introduced to the body without the physician’s knowledge,” said Norm Furbush, Syntervention Founder and President. “We are committed to the elimination of preventable contamination during invasive medical procedures, a problem that adds to hospital costs and complications that are often under-reported.”
In a recent podium presentation entitled, “Microscopic Foreign Body Contamination During Interventional Procedures” delivered at the New Cardiovascular Horizons Conference in New Orleans, LA, June 9th, 2012, Marsha Holton, CCRN, RCIS, FSICP, concluded that severe complications may occur even after achieving an optimal procedural result and a fiber-free material is a viable option to reduce microscopic foreign body contamination in the interventional lab. “We must do all we can to minimize risks to our patients and reduce liability and costs to the hospital.”
For more information, visit www.syntervention.com.
Frail, Older Adults With High Blood Pressure May Have Lower Risk of Mortality
A new study suggests that higher blood pressure is associated with lower mortality in extremely frail, elderly adults. The study, published July 16 in the Journal of the American Medical Association’s (JAMA) Archives of Internal Medicine, looked at a nationally representative group of 2,340 adults ages 65 and older. The researchers found that lower blood pressure protected healthier, robust older adults but the same may not be true for their more frail counterparts.
Lead author Michelle Odden, a public health epidemiologist at Oregon State University, said blood pressure rises naturally as people age. Her study used walking speed as a measure of frailty. Participants were asked to walk a distance of contabout continued from previous page
20 feet at their normal rate. Those who walked less than 0.8 meters per second were defined as slower walkers. Those who walked faster than 0.8 meters per second were in the second group of more robust adults, who also had a lower prevalence of diabetes, coronary heart disease, stroke and heart failure.
The third group included those who were not able to complete the walking test for various reasons, including inability to walk 20 feet.
“As we age, our blood vessels lose elasticity and becomes stiff,” Odden said. “Higher blood pressure could be a compensatory mechanism to overcome this loss of vascular elasticity and keep fresh blood pumping to the brain and heart.”
Odden said the mortality differences between the fast walkers and slow walkers or non-completers can be explained simply — everyone ages differently.
“There is a profound difference in the physiological age of an 80-year-old man who golfs every day, and someone who needs a walker to get around,” she said. “So in the fast walkers, high blood pressure may be more indicative of underlying disease, not just a symptom of the aging process.”
Among the faster walkers, those with high blood pressure had a 35 percent greater risk of dying compared with those with normal blood pressure.
In contrast, there was no association between high blood pressure and mortality in the slow walking group. Strikingly, those who were unable to complete the walking test had the opposite results — those with higher blood pressure had a 62 percent lower mortality rate.
Since this is one of the first studies to examine walking speed, mortality and blood pressure, Odden cautioned against people making health decisions based on these early findings.
“Any sort of decision regarding medication use should be done in consultation with a physician,” she said. “Our study supports treating high blood pressure in healthy, active older adults. But in frail older adults, with multiple chronic health conditions, we need to take a closer look at what sorts of effects high blood pressure could serve and whether having a higher blood pressure could be protective.”
Odden is an expert on chronic disease and disease prevention in aging populations, particularly in regard to cardiovascular health and kidney disease. Her work is funded by the National Institute on Aging and the American Heart Association Western States Affiliate.
Cardiovascular Credentialing International Announces Changes to Qualification Pathways
Changes go into effect July 1, 2013, for five credentialing programs.
Cardiovascular Credentialing International (CCI) announced changes to its qualification pathways for five of its credentialing programs. The effective date of these changes will be July 1, 2013. The affected credentialing programs include the following:
- Registered Cardiovascular Invasive Specialist (RCIS)
- Registered Cardiac Sonographer (RCS)
- Registered Vascular Specialist (RVS)
- Registered Cardiac Electrophysiology Specialist (RCES)
- Registered Congenital Cardiac Sonographer (RCCS)
The eligibility changes include the following:
- Applicants applying under a pathway requiring on-the-job training for the RCS, RVS, and RCCS registry level credentials are required to perform a minimum of 600 studies in the corresponding specialty.
- Candidates who graduated with a diploma, associate, or baccalaureate degree from an academic program in health science, which is not programmatically accredited in the specialty for which they are applying, will not be eligible to sit for the certification exams until they have completed the required work experience/on-the job training (one year).
- For the RCIS credentialing program, the RCIS1 qualification pathway will be discontinued. This pathway, which is also referred to as the Two Year On-the-Job Training qualification pathway, allowed applicants to qualify by ONLY having been employed for two years or more (full-time or full-time equivalent) in Invasive Cardiovascular Technology.
For details, please visit www.cci-online.org/new-examination-qualifications.
About CCI: CCI is a not-for-profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI began credentialing cardiovascular professionals in 1968. CCI is governed by a Board of Trustees and a Board of Advisors. The CCI Board of Advisors is comprised of representatives nominated by the following organizations to represent their cardiovascular specialty field: American College of Cardiology (ACC), American College of Phlebology (ACP), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Diagnostic Medical Sonography (SDMS), Society of Invasive Cardiovascular Professionals (SICP), and the Society for Vascular Ultrasound (SVU).
Vector™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheters Cleared by FDA
r4 Vascular, Inc., Maple Grove, MN, announced clearance from the United States Food and Drug Administration (FDA) to market the Vector™ Percutaneous Transluminal Angioplasty (PTA) balloon catheters in 28 sizes. All Vector™ balloon catheter sizes are rated for up to 30 atmospheres of pressure and are radiopaque when deflated or inflated.
r4’s patent pending Vector™ balloon catheter also includes radiopaque stripes on the balloon. Instead, clinicians may use low-viscosity saline which reduces inflation/deflation time up to 50% and may reduce x-ray exposure to the patient and clinicians. Vector includes advanced catheter shaft technology to improve catheter tracking and handling.
For more information, please visit https://www.r4vascular.com/
Bloodstream Scavenger Inhibits Clotting Without Increased Bleeding
A compound that mops up debris of damaged cells from the bloodstream may be the first in a new class of drugs designed to address one of medicine’s most difficult challenges — stopping the formation of blood clots without triggering equally threatening bleeding.
In a mouse study published online July 23, 2012, in the journal Proceedings of the National Academy of Sciences, Duke University Medical Center scientists report that the experimental compound called PAMAM G-3 actually prevents activation of the process that leads to the formation of dangerous blood clots, while avoiding any impact on the factors that are essential to normal blood clot formation.
“In the thrombosis (clotting) space, the holy grail has been to make something anti-thrombotic that doesn’t significantly increase your chance of hemorrhage or bleeding,” said Bruce A. Sullenger, PhD, director of the Duke Translational Research Institute and senior author of the study. “We think this is a promising example of a type of compound that could do that. If it can be clinically developed and exhibit the same properties in humans, clearly that would improve safety and outcome of treating patients who have thrombotic disease.”
If you can control thrombosis without greatly increasing hemorrhage or bleeding risk, you would address a major unmet medical need,” Sullenger said. “It would have potentially major clinical implications.”
The thrombosis study builds upon previous work by Sullenger and his group. They showed that the compounds called nucleic acid-binding polymers or NABPs, which include PAMAM G-3, have potent anti-inflammatory properties. Work published last year by Sullenger’s lab demonstrated the polymer’s potential to interrupt the inflammatory response that is the hallmark of auto-immune disorders such as lupus and multiple sclerosis.
It had been shown previously that dying and diseased cells spill nucleic acids into the bloodstream at high levels — rogue bits of DNA and RNA that trigger an inflammatory immune response. Noting that any circulating nucleic acids or inorganic polyphosphates also seem to trigger the coagulation response, the researchers hypothesized that NBAPs might also be effective anti-coagulants. In test tube-based assays and experiments in two mouse models of thrombosis, the NABPs proved to be potent inhibitors of thrombosis without simultaneously triggering abnormal bleeding.
After screening several of the NABPs, which were originally developed for other biomedical applications, the team settled on PAMAM G-3 due to its combination of anticoagulant potency and low toxicity.
“We found that other [NABP] compounds were more toxic, but this particular compound, PAMAM G-3, had been purported to be less toxic in mouse models, so that’s why we chose it for our further studies,” said Shashank Jain, PhD, the study’s lead author and a post-doctoral associate at Duke.
The researchers plan further work to better understand how the nucleic acids and polyphosphates are mediating the coagulation response. They will also engineer additional NABP compounds to improve potency, safety and tolerability. And of course they have their sights set on the clinic, but that is a few years away.
“Clearly we want to think about other animal models and then translating it eventually into human studies,” Sullenger said. “In a variety of the major diseases, thrombosis is an important clinical problem, and the challenge is always, how do you treat it without causing bleeding problems?”
The study was supported in part by funds from National Heart, Lung, and Blood Institute (HL065222).
