Breaking News
November 18, 2018 - Using light to control crucial step in embryonic development
November 18, 2018 - Unusual case of father-to-son HIV transmission reported
November 18, 2018 - FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea
November 18, 2018 - Poverty blamed on widening north-south gap in young adult deaths in England
November 18, 2018 - Progress in meningitis lags far behind other vaccine-preventable diseases, analysis shows
November 18, 2018 - Consensus Statement Issued on Management of Foot, Ankle Gout
November 18, 2018 - Fine particle air pollution is a public health emergency hiding in plain sight
November 18, 2018 - In-hospital mortality higher among patients with drug-resistant infections
November 17, 2018 - Research shines new, explanatory light on link between obesity and cancer
November 17, 2018 - FIND explores new diagnostic assays for confirmatory HCV diagnosis in community settings
November 17, 2018 - Tracking Preemies’ Head Size May Yield IQ Clues
November 17, 2018 - Scientists call for unified standards in 3-D genome and epigenetic data
November 17, 2018 - Lab Innovations 2018 has beaten all records by attracting 3,113 attendees
November 17, 2018 - Sexuality education before age 18 may reduce risk of sexual assault in college
November 17, 2018 - New model of FSHD could be useful to study effectiveness of experimental therapeutics
November 17, 2018 - FDA approves antibacterial drug to treat travelers’ diarrhea
November 17, 2018 - Lab Innovations 2018 confirmed as a major hit with visitors, exhibitors and speakers
November 17, 2018 - Largest parasitic worm genetic study hatches novel treatment possibilities
November 17, 2018 - UCLA biologists uncover how head injuries can lead to serious brain disorders
November 17, 2018 - Static and dynamic physical activities offer varying protection against heart disease
November 17, 2018 - Obesity significantly increases risk of Type 2 diabetes and coronary artery disease
November 17, 2018 - People with rare cancers can benefit from genomic profiling, shows research
November 17, 2018 - NIH awards over $1.8 million to husband-and-wife doctors to test new breast cancer approach
November 17, 2018 - Four-in-one antibody used to fight flu shows promise in mice
November 17, 2018 - New approach allows pathogens to be starved by blocking important enzymes
November 17, 2018 - Higher body mass index could cause depression even without health problems
November 17, 2018 - Protein which plays role in sensing cell damage serves as new target to treat pulmonary hypertension
November 17, 2018 - FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
November 17, 2018 - ID specialist input improves outcomes for outpatient parenteral antimicrobial therapy
November 17, 2018 - UT Southwestern scientists selected to receive 2019 Edith and Peter O’Donnell Awards
November 17, 2018 - New clinical algorithm to help individuals manage type 2 diabetes when fasting during Ramadan
November 17, 2018 - Researchers identify LZTR1 as evolutionarily conserved component of RAS pathway
November 17, 2018 - Heart Disease Leading Cause of Death in Low-Income Counties
November 17, 2018 - Estrogen Levels Test: MedlinePlus Lab Test Information
November 17, 2018 - Research reveals link between immunity, diabetes
November 17, 2018 - Research shows how to achieve improved smoking cessation outcomes within California’s Medicaid population
November 17, 2018 - New study finds less understanding and implementation of patient engagement
November 17, 2018 - New shoe insole technology could help diabetic ulcers heal better while walking
November 17, 2018 - New method to extend cell division and immortalization of avian-derived cells
November 17, 2018 - Australian Academy of Science urges parents to vaccinate children against meningococcal disease
November 17, 2018 - Hot water treatment may help improve inflammation and metabolism in sedentary people
November 17, 2018 - Researchers produce 3D chemical maps of small biological samples
November 17, 2018 - Must Blood Pressure Rise Wth Age? Remote Tribes Hold Clues
November 17, 2018 - Noonan Syndrome
November 17, 2018 - Interventions to delay and prevent type 2 diabetes are underused, researchers say
November 17, 2018 - Hackathon prize winner seeks to remotely monitor patient skin conditions
November 17, 2018 - Research team identifies Ashkenazi Jewish founder mutation for Leigh syndrome
November 17, 2018 - Gene editing could be used to halt kidney disease in patients with Joubert syndrome
November 17, 2018 - Study uncovers link between gut disruption and aging
November 17, 2018 - Teens more likely to pick up smoking after exposure from friends and family
November 17, 2018 - Nicoya designate the Institute for Stem Cell Biology and Regenerative Medicine as the OpenSPR Centre of Excellence
November 17, 2018 - new horizon in dental, oral and craniofacial research
November 17, 2018 - How does poor air quality affect your health?
November 17, 2018 - New device can regulate children’s blood glucose more like natural pancreas
November 17, 2018 - Game-Changers in Western Blotting and Protein Analysis
November 17, 2018 - FDA announces new actions to limit sale of e-cigarettes to youth
November 17, 2018 - Warmer winter temperatures related to higher crime rates
November 17, 2018 - MCO places increasing emphasis on helping people find and access healthy food
November 17, 2018 - Group of students aim to improve malaria diagnosis using old smartphones
November 17, 2018 - Transplantation of feces may protect preterm children from deadly bowel disease
November 17, 2018 - Researchers explore whether low-gluten diets can be recommended for people without allergies
November 17, 2018 - New and better marker for assessing patients after cardiac arrest
November 17, 2018 - For 7-year-old with failing bone marrow, a life-saving transplant | News Center
November 17, 2018 - New first-line treatment for peripheral T-cell lymphoma approved by FDA
November 17, 2018 - Artificial intelligence could be valuable tool to help young victims disclose traumatic testimony
November 17, 2018 - Breakthrough in the treatment of Restless Legs Syndrome
November 16, 2018 - FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib
November 16, 2018 - Eagle Books | Native Diabetes Wellness Program
November 16, 2018 - Patients with common heart failure more likely to have lethal heart rhythms
November 16, 2018 - How AI could help veterinarians code their notes | News Center
November 16, 2018 - Bias-based bullying does more harm to students than generalized bullying
November 16, 2018 - Researchers find first direct evidence that cerebellum plays role in cognitive functions
November 16, 2018 - Non-coding genetic variant plays key role in endothelial function and disease incidence
November 16, 2018 - EMA recommends first all-oral treatment to tackle deadly sleeping sickness
November 16, 2018 - Drug used to treat dizziness may slow down growth of triple-negative breast cancer
November 16, 2018 - AHA: Icosapent Ethyl Cuts CV Risk From Elevated Triglycerides
November 16, 2018 - ‘Orphan’ RNAs make cancer deadlier, but potentially easier to diagnose
November 16, 2018 - Air Cube touches down at hospital | News Center
November 16, 2018 - CRISPR-based tool shown to enhance cell-based immunotherapy
November 16, 2018 - Mechanisms that govern HIV latency differ in the gut and blood, finds study
FDA grants marketing authorization for use of two catheter-based devices in hemodialysis patients

FDA grants marketing authorization for use of two catheter-based devices in hemodialysis patients

image_pdfDownload PDFimage_print

Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis.

Specifically, the FDA granted marketing authorization for the use of the Ellipsys Vascular Access System and the everlinQ endoAVF System to make what’s called an arteriovenous (AV) fistula for patients who need hemodialysis access.
“Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

According to the National Institutes of Health, more than 661,000 Americans have kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or artificial kidney, to filter a patient’s blood outside of their body. Before patients can start dialysis, however, they need to have an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After some time, the mature vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically take several months to heal and for the vein to mature before being usable for hemodialysis.

The devices granted marketing authorization today are designed to create AV fistulas percutaneously (through the skin). A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, the everlinQ endoAVF System uses two.

For the Ellipsys Vascular Access System, the FDA reviewed data from a non-randomized, multi-center study of 103 patients. The Ellipsys Vascular Access System was used in a procedure to create an AV fistula in these patients, of which 92 patients (89.3 percent) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.1 percent) required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

For the everlinQ endoAVF System, the FDA reviewed data from a non-randomized, multi-center study of 60 patients, in addition to supporting data from three other studies and clinical use of the device outside the U.S. The everlinQ endoAVF System was used in a procedure to create an AV fistula in these patients. In the main study, 52 patients (86.7 percent) met the criteria for a usable AV fistula within three months after the procedure. Almost all patients (96.7 percent) required an additional procedure at the time the fistula was created, while 28.3 percent of patients required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

Both devices are contraindicated, or should not be used, for creation of anastomoses (connections) in vessels that are less than two millimeters in diameter or too far apart (for example, in the wrist or in the hand). For both devices, complications include blocking (occlusion) or collapse (stenosis) of the fistula, bruising and need for additional procedures.

The Ellipsys Vascular Access System and everlinQ endoAVF System were reviewed through the De Novo premarket review pathway, a regulatory pathway for some low to moderate risk devices of a new type. This action also creates a new regulatory classification, which means that subsequent devices with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Ellipsys Vascular Access System to Avenu Medical.

The FDA granted marketing authorization of the everlinQ endoAVF System to TVA Medical, Inc.

Tagged with:

About author

Related Articles