WavelinQ™ 4F EndoAVF System Receives 510(k) Clearance from FDA
In February, BD (Becton, Dickinson and Company), a global medical technology company, received 510(k) clearance from the US Food and Drug Administration for the BD WavelinQ™ 4 French (4F) endoAVF system. The system is a recent innovation in endovascular arteriovenous fistula (endoAVF) creation technology; it allows for the creation of an AVF in either the ulnar artery and ulnar vein or the radial artery and radial vein and expands on the current indication for the BD WavelinQ™ 65F endoAVF system.
According to a press release, the BD WavelinQ 4F endoAVF system “provides clinicians with a minimally invasive AVF creation alternative to open surgery.” The system increases the anatomical AVF location options and enables additional venous wrist access points, creating procedural flexibility for physicians and reducing risk of scarring or arm disfigurement for patients compared with open surgical AVF creation.
Paul Kreienberg, MD, Albany Medical Center, said, “With BD WavelinQ 4F endoAVF system, I can provide my ESRD patients with two additional fistula location options compared to a surgical fistula. These additional AV fistula sites and a minimally invasive procedure can increase the likelihood that patients will get a usable AV fistula.”
Steve Williamson, worldwide president of peripheral intervention at BD, said, “People living with ESRD are an underserved patient population with very limited treatment options available to them. We’re excited to add BD WavelinQ 4F endoAVF system to our portfolio of technologies that create, restore, and/or maintain AV access for patients on hemodialysis. Endovascular specialists now have an additional tool that enables the flexibility needed to support AV fistula creation for their patients.”
American Kidney Fund Names Research Fellows
The American Kidney Fund’s (AKF) Clinical Scientist in Nephrology Program is marking its 30th year in 2019. In a press release, the Fund announced the appointment of two research fellowships: Olivia Alison Potok, MD, a research fellow in nephrology at the University of California, San Diego, and Pablo Garcia, MD, a research fellow at Stanford University.
Through the AKF, the program funds researchers whose work aims to improve the diagnosis, treatments, and outcomes for patients with chronic kidney disease. Both of the newly announced fellowships will begin in July.
LaVarne A. Burton, president and CEO of AKF, said, “The research that Dr. Potok and Dr. Garcia will conduct promises to produce important insights with practical applications in the clinical setting. Over the past 30 years, the American Kidney Fund has granted research fellowships to 43 brilliant young nephrologists with one overarching goal: improving the care and treatment of patients with kidney disease. These nephrologists have, in turn, gone on to become leaders in the field and mentors to new generations of scientists studying kidney disease.
Dr. Potok’s research, funded with support form Akebia Therapeutics, Inc., will focus on improving understanding how two common markers used to estimate kidney function relate to aging and body composition. Dr. Garcia will work to clarify the causes and prognosis of primary tubulointerstitial kidney disease, a disorder in which the spaces between the kidney tubules become inflamed for unclear reasons.
TeleHealth Services Installs 3000th AV and Entertainment System
In a recent press release, TeleHealth Services announced the completion of its 3000th installation of audiovisual and entertainment systems to serve dialysis centers and patients. TeleHealth systems are in dialysis centers in each of the 50 states, including four of the top five clinical treatment providers, according to the press release. TeleHealth also offers advanced patient engagement and education solutions using patient room televisions and tablets for patients and staff.
Dan Nathan, executive vice president of operations for TeleHealth, said, “For patients in clinics and hospitals, the television offers a distraction during a challenging time. Quality television programming presents clinics and hospitals with a unique opportunity to engage and entertain patients. We work with our dialysis center customers to provide patient entertainment and AV services that improve convenience and satisfaction for patients receiving dialysis treatment, including the latest television equipment and familiar TV programming options.
“Patients appreciate entertainment options and amenities that offer the comforts they have at home. We are committed to providing innovative, turnkey technology solutions that help our hospital and clinic partners provide an exceptional patient experience.”
Prediction Tool Identifies Risk for Recurrent Kidney Stone Formation
Researchers from the Mayo Clinic in Rochester, Minnesota, recently described a new tool that can be used to predict which patients with recurring kidney stones are at the highest risk of remission. According to an article in Medical News Today, the Mayo researchers utilized 1984-2017 data from the Rochester Epidemiology Project that focused on chronic kidney stone formers from Olmsted County, Minnesota, representing 3364 patients with a total of 4951 stone-forming episodes.
With the identification of individuals most likely to experience repeat kidney stones, some patterns emerged; repeat stone formers tended to be male and younger and have higher body mass index. A family history of kidney stones and previous pregnancies are also risk factors for forming repeat stones.
An earlier tool that used 11 factors to predict the risk of repeat stone forming did not perform well on patients who had previously experienced ≥2 occurrences. The updated tool uses 13 independent predictors, including questions about sex, kidney stone history, and race, that extend the tool’s use and increase its prediction accuracy.
US Launch of 2008T BlueStar™ Hemodialysis Machine Announced
The market availability of the 2008T BlueStar™ hemodialysis machine has been announced by Fresenius Medical Care North America’s Renal Therapies Group. The machine incorporates evolved technologies and improved performance with more than 30 unique enhancements, representing the most comprehensive upgrade in company history, according to a press release form Fresenius.
The 2008T BlueStar machine is designed to provide simpler operation and maintenance with enhanced user control; the desired results include labor and cost savings, improved accuracy, enhanced data stream, and additional treatment options.
Mark Costanzo, president of the Renal Therapies Group at Fresenius Medical Care North America, said, “The new and enhanced 2008T BlueStar hemodialysis machines provide more than 30 unique enhancements to better serve end-stage renal disease patients undergoing dialysis. Our new machines represent a significant step forward for providers and patients who depend upon our life-sustaining technologies, and an exciting continuation of our 30-year commitment to the treatment of end-stage renal disease.”
Enhancements of the upgraded machine include auto start, auto prime, assisted refusion, idle mode, independent conductivity and pH self-test, disinfection log, PatientCards (optional), low volume therapy, sustained low efficiency dialysis, and enhanced Crit-Line® treatment data.
“Leveraging our history of innovation and industry firsts in renal care, we are pleased to unveil new features that will help providers deliver the highest quality of care to patients receiving hemodialysis both in-center and in the acute care setting,” Robert Kossmann, MD, chief medical officer at Renal Therapies Group at Fresenius Medical Care North America, said. “We believe our 2008T BlueStar machine offers distinct clinical advantages that streamline the complexities of hemodialysis care and enhance patients’ overall treatment experience.”
All enhancements are available for existing 2008T hemodialysis machines through an upgrade process.
Fresenius Medical Care Completes Acquisition of NxStage Medical
Following approval by US antitrust authorities, Fresenius Medical Care has successfully completed the acquisition of NxStage Medical, Inc. Fresenius Medical Care is the world’s largest provider of dialysis products and services; NxStage Medical develops, produces, and markets medical devices used in home dialysis and critical care.
In a press release, Rice Powell, chief executive officer of Fresenius Medical Care, said, “The closing of this transaction is an important milestone in enhancing our patients’ choice of dialysis treatment modality. By combining NxStages’s capabilities with our broad product and service offering, we can help patients to live even more independently. In addition to broadening our product portfolio, this acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies.”
Bill Valle, Fresenius chief executive officer, added, “It’s a great pleasure to welcome our new NxStage colleagues. With their strong culture of innovation and transformation, they will help us to realize our vision of delivering access to superior patient care and outcomes in a lower-cost-of-care home setting for all the patients we care for. We are excited to execute on a strategy that is good for patients, the healthcare system, and us.”
Satellite Healthcare Announces Majority Ownership of Tri-County Vascular Care
Satellite Healthcare, a not-for-profit dialysis provider in San Jose, California, has announced their purchase of a majority ownership of Tri-County Vascular Care, a freestanding vascular access surgery center. The purchase will allow Satellite Healthcare to provide dialysis patients in the South Bay area with vascular access surgical services. Satellite will assume leadership of the center in partnership with other area physicians. The combined expertise of Satellite Healthcare and Tri-County Vascular Care will create a resource to fulfill patients’ needs for optimal dialysis access, including fistulas, grafts, and peritoneal dialysis catheters.
In a press release, Rick Barnett, president and CEO of Satellite Healthcare, said, “Purchasing Tri-County Vascular Care offers access to a consistent team of medical professionals in a comfortable and friendly environment where the care of dialysis patients is a top priority. Vascular access staff are highly trained and can offer expedient service and focused attention.”
Ellipsys® Vascular Access System Cleared for Use at VA Hospital
The US FDA recently cleared the Ellipsys® Vascular Access System for use in the creation of a percutaneous arteriovenous fistula (AVF), a less invasive innovation for patients with end-stage renal disease (ESRD). According to a recent press release, Mark Randel, MD, recently performed the new procedure at the Jack C. Montgomery Veterans Affairs (VA) Medical Center. The facility is the first VA center to offer the Ellipsys System.
In an interview published in Vantage Point, the official blog of the US Department of Veterans Affairs, Dr. Randel said, “This is a very innovative way of creating vascular access. It’s a game changer, and it transforms a commonly performed traditional surgery into a minimally invasive procedure that will benefit the veterans we serve.”
The system, developed by Avenu Medical in San Jose, uses an endoscopic approach to create the dialysis access. In the procedure, the Ellipsys catheter is advanced through the skin and into a vein, under ultrasound, to create access, leaving the tissue undisturbed.
According to the press release, Avenu has received a US Federal Contractors Service Agreement giving the company the ability to provide the Ellipsys technology to VA facilities nationwide. Ed Chang, cofounder and vice president of marketing at Avenu, said, “We are incredibly proud that the heroes of our nation, our military veterans, are among the first to receive this state-of-the-art treatment so they can get the care they need and deserve. Although ESRD is a global problem, the prevalence rate of ESRD among veterans is significantly higher than the general population. Therefore, working with the VA, we can directly address this pressing clinical need and take major steps toward fulfilling a treatment gap.”