ANGIODYNAMICS BEGAN SHIPPING NEW MIDLINE CATHETERS IN AUGUST
AngioDynamics, a provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, is shipping the BioFlo Midline catheter indicated for short-term intravenous therapies. The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the BioFlo Midline catheter earlier this year.
The BioFlo Midline catheter often delivers the same medications, including a variety of antibiotics, as a peripheral intravenous catheter (PIV.) However, Midlines can provide access for up to 30 days while PIVs typically need to be replaced every couple of days, usually due to performance failure. Midline catheters are ideal for patients who may require more than five days of intravenous therapy.
"The BioFlo Midline catheter is a logical extension of the BioFlo product line, bringing the clinically relevant thrombus reduction properties to patients needing shorter term vascular access to deliver infusion therapies," said Chuck Greiner, AngioDynamics' senior vice president, Global Franchise Leader. "Its increased period of functionality improves patient satisfaction by lowering the number of needle sticks and interruptions to treatment. Similarly, it offers health care providers an expanded range of patient treatment options that help to increase staff efficiency and reduce the overall cost of care. We see BioFlo as the future of intravenous therapy delivery and our customers agree."
The BioFlo Midline catheter with Endexo Technology is indicated for short-term or up to 30 days of peripheral access to the venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood and for power injections of contrast media.
Joseph M. DeVivo, AngioDynamics' president and CEO, said BioFlo product line sales grew at a double digit rate last fiscal year. “And the Midline's launch, along with continued account wins and market penetration, position us for additional solid BioFlo growth this fiscal year."
MERZ DERMAL FILLER FOR HANDS, RADIESSE, GETS FDA APPROVAL
The U.S. Food and Drug Administration (FDA) has approved Merz North America’s injectable dermal filler Radiesse for hand augmentation to correct volume loss in the dorsum of the hands, the company announced June 4. "Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year," a company spokesman said. Radiesse is an opaque dermal filler composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier. It was first approved in the United States in 2001, and has since had subsequent approvals, including for correction of nasolabial folds in 2006. It has been used off-label for hand augmentation — and is approved in 52 countries for that indication.
Data to support FDA approval for hand augmentation came from a multicenter, randomized controlled study of 114 patients. Most were white women with an average age of 53 years. Eighty-five patients were randomly assigned to immediate treatment, and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks.
The effectiveness of Radiesse was measured by the Merz Hand Grading Scale (MHGS) — validated by the company in another study — and the Global Aesthetic Improvement Scale (GAIS), which the patients used to self-assess results.
According to the scale, 75 percent of Radiesse patients experienced at least a one-point improvement at three months compared with 3 percent of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group.
In addition, 98 percent of treated patients reported improvement in the appearance of their hands at three months. Improved aesthetic outcomes as measured on the GAIS after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met, the spokesman said.
Most adverse events were injection site reactions such as swelling, redness, pain and bruising, which were usually mild to moderate, short in duration (lasting about a week), and required no treatment. No severe device-related adverse events were reported that required treatment, according to the company.
Radiesse is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders.
THE MEANINGFUL USE PROGRAM CONTINUES TO DRAW CRITICISM
The third stage of the Meaningful Use program could leave even tech-savvy providers unable to meet requirements, as they must depend on the health IT adoption of others, says Niam Yaraghi, a fellow at the Brooking Institution's Center for Technology Innovation.
Stage 3 of Meaningful Use requires that providers send electronic summaries for patients they refer to other providers, receive summaries for patients referred to them and reconcile former patient data with newer reports, Yaraghi wrote in a U.S. News and World Report. However, if other providers do not have the ability to send or receive those summaries, which is required to meet Meaningful Use Stage 2, the second and third requirements of Stage 3 cannot be completed, he says.
In addition, the rule requires that providers ask new patients to say who their previous physicians were in order to obtain the care summaries, which "ignores that fact that in many critical instances patients are unable to recall all the medical providers whom they have previously visited," Yaraghi stated.
"Given the distance between the proposed rules of the Meaningful Use program and the reality of the healthcare market, the program's success should be considered a miracle," he writes. "Even if this miracle happens, we will not achieve much in terms of quality or efficiency in the healthcare system."
Yaraght isn't the only critic of the third and final stage of the program. The American Medical Association (AMA) and the Medical Group Management Association (MGMA), among others, are calling for a delay to the rule.
AMA says the program "will create significant challenges for physicians, patients, and vendors." In addition, MGMA says Stage 3 could result in a failure to meet the goals outlined in the American Recovery and Reinvestment Act of 2009. It should be delayed, MGMA says, until it is known what the impact of Medicare Access and CHIP Reauthorization Act of 2015 will be.
BAXTER RECALLS ONE LOT OF IV SOLUTION, CITING SEVERAL POSSIBLE PROBLEMS
Baxter International Inc. is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
The lot being recalled, C964601, was distributed to customers and distributors nationwide between Jan. 22 and Feb. 12. For further information, contact Baxter Healthcare Center at 1-888-229-0001, email email@example.com or see baxter.com.
Deborah Manjoney, MD, FACS, RPVI
Deborah Manjoney, MD, FACS, RPVI, opened the Wisconsin Vein Center and MediSpa in 2002, and in 2004 she left her 18-year practice in cardiovascular and thoracic surgery to devote herself to fulltime practice of phlebology. She was one of the first in the area to add the “medispa” concept to her practice. Please see her comprehensive aticle on what has happened to all the government regulations this year on Page 1.