LUTONIX® 035 DCB Granted FDA Approval
In late August, the US FDA granted premarket approval to the LUTONIX® 035 drug coated balloon (DCB) PTA catheter. The LUTONIX 035 is now available in the United States.
In a press release from C.R. Bard, Inc., the manufacturer of the catheter, Timothy M. Ring, chairman and chief executive officer, said, “This approval offers a new treatment option for patients suffering from end-stage renal disease. In line with our continued commitment to deliver products that improve patient care, we are proud to extend the benefits of the LUTONIX 035 DCB catheter to help preserve treatment options for US patients.”
The LUTONIX 035 is the first and only drug-coated balloon that is approved by the FDA as safe and effective in patients who are facing kidney failure and who have stenotic lesions in arteriovenous (AV) dialysis fistulae. This approval adds to the previous FDA indication of the LUTONIX 035 DCB catheter for the treatment of superficial femoral artery and popliteal artery disease.
Scott O. Treotola, MD, the Stanley Baum professor of radiology, associate chair, and chief, international radiology at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, and the principal investigator of the LUTONIX AV clinical trial, said, “For patients undergoing hemodialysis for kidney failure, who already spend a significant portion of their time undergoing dialysis and other treatments, repeated reinterventions to maintain AV access can be an added burden, with many patients returning as frequently as every other month. The LUTONIX 035 DCB catheter provides another option for physicians. It’s intended to offer patients with end-stage renal disease fewer interruptions in treatment and less time undergoing access maintenance, potentially leading to improved patient satisfaction and quality of life.”
No Link Between Marijuana Use and Kidney Function in Young Healthy Adults
A recent study found little evidence that kidney function in young healthy adults is affected by marijuana use. Researchers at the University of California, San Francisco, and the San Francisco Veterans Affairs Medical Center recently conducted the first study designed to examine potential links between marijuana use and kidney function in a population of young healthy adults. Data from the Coronary Artery Risk Development in Young Adults study were used for the current study. That data includes repeated assessments of marijuana use and kidney outcomes.
In an article in Medical News Today, Julie Ishida, MD, MAS, said, “Results from our observational study in young adults with normal kidney function may not translate into a clinically meaningful difference and may be insufficient to inform decision-making concerning marijuana use; however, it is possible that the association between marijuana use and kidney function could be different in other populations such as older adults or patients with kidney disease, so additional research is needed.”
Results of the study are reported in the Clinical Journal of the American Society of Nephrology.
NxStage System One™ Used in Nine of Top Ten Nephrology Hospitals in US
In a press release from NxStage Medical, Inc., the company announced that the NxStage System One™ is now used in nine of the top ten nephrology hospitals in the United States and in 15 of the top 20. The System One simplifies care in acute care settings and allows staff to deliver the prescribed renal replacement therapy via a variety of modalities to critically ill patients. The ranking was reported in US News & World Report.
According to the press release, System One offers multiple features designed to simplify therapies in hospitals. The features include the NxView interface with graphic touch system display that provides treatment information and charting assistance, a drop-in cartridge that allows multiple therapies, no waste bags, and no special electrical or plumbing needs. In addition, the range of flow rates in System One allows hospital staff to customize therapy based on the patient’s condition.
NxStage Medical and Dialyze Direct Partner in Ohio
In a recent press release from NxStage Medical, Inc., the company announced that its NxStage Kidney Care subsidiary is forming a partnership with Dialyze Direct to provide on-site dialysis to skilled nursing facility patients in Ohio. NxStage Medical is a medical technology company that focuses on advancements in renal care; Dialyze Direct is a leader in geriatric dialysis that provides staff-assisted home hemodialysis to patients in skilled nursing facilities.
Dialyze Direct will combine its model of care specifically designed for the geriatric patient population in skilled nursing facilities in Ohio to provide on-site dialysis utilizing the NxStage System One™. On-site dialysis lessens the burdens of organizational and operational challenges and reduces or eliminates the stress that transporting patients for dialysis creates. Results of studies have demonstrated reductions in hospitalizations and mortality in patients receiving on-site, more frequent hemodialysis at skilled nursing facilities.
Henry Kauftheil, chairman of Dialyze Direct, said in the press release, “Our mission is to deliver innovative and compassionate dialysis care to geriatric patients in skilled nursing facilities and we realized we needed an alternative strategy to meet the growing demand for our services in certain states such as Ohio where we do not yet have an operating presence. NxStage is an ideal partner to help us expand our footprint and bring our much-needed services to skilled nursing facility patients.”
Jeff Burbank, chief executive officer and founder of NxStage Medical, added, “We believe the skilled nursing facility market represents an opportunity to improve outcomes and quality of life for skilled nursing patients, as well as to improve overall costs of care, by reducing transportation costs and rehospitalization rates. We look forward to working with Dialyze Direct to address unmet needs in skilled nursing facility end-stage renal disease.”
FDA Approval for Vabomere Granted in August
The US FDA approved Vabomere for adults with complicated urinary tract infections, including pyelonephritis, a type of kidney infection caused by specific bacteria. Vabomere contains meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.
In a press release from the FDA, Edward Cox, MD, director of the Office of Antimicrobial Products in the agency’s Center for Drug Evaluation and Research, said, “The FDA is committed to making new safe and effective antibacterial drugs available. This approval provides an additional treatment option for patients with complicated urinary tract infection, a type of serious bacterial infection.”
In a clinical trial that included 545 adults with complicated urinary tract infection, including patients with pyelonephritis, approximately 98% of patients treated with Vabomere were cured or had improvements in symptoms and a negative urine culture test, compared with 94% of the group treated with another antibacterial drug (piperacillin/tazobactam). At 7 days following completion of treatment, 77% of those in the Vabomere group had resolved symptoms and a negative urine culture compared with 73% in the control group.
The Vabomere approval was granted to Rempex Pharmaceuticals.