Baxter Announces U.S. FDA De Novo Authorization for Theranova Dialyzers Enabling HDx Therapy
U.S.patients with kidney failure now have access to expanded hemodialysis (HDx) therapy delivered by Theranova, a new class ofdialyzer
- Theranova dialyzer’s unique membrane design offers a filtration profile that more closely mimics that of the natural kidney and can be used with existing hemodialysis machines1,2
- Theranova was reviewed by FDA through the De Novo process, a pathway for novel low- to moderate-risk devices
By granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in
HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane required. Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off® membrane combines high permeability and selectivity for uremic toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment2,3. This unique cut-off and high retention onset profile expands clearance, allowing for filtration closer to that of the natural kidney2,6.
“U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova,” said
To date, over 90 independent and Baxter-led or sponsored studies have been conducted on HDx therapy enabled by Theranova. The studies evaluated a range of clinical and quality-of-life measures, including the ability to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.
“Individually, the side effects from standard HD, which patients typically undertake three days a week, four hours per day, may seem manageable. However, the chronic effects of treatment accumulate and over time, cause some patients to give up on therapy,” explained
Due to the novel nature of Theranova, Baxter conducted a randomized controlled clinical study in
Launched outside of the
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Rx Only.For safe and proper use of this device, refer to the Instructions for Use.
The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.
This release includes forward-looking statements concerning Theranova, including potential benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other
Baxter, MCO and Theranova are trademarks of
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1 Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017; 32:165-172.
2 Zweigart C, et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328-334
3 Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.
4 Neirynck N, et al. An update on uremic toxins. Int Urol Nephrol. 2013; 45:139-50.
5 Duranton F, et al.
6 Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448.
7 Weiner D, et al. Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer. CJASN doi: 10.2215/CJN.01210120.
8 Wolley M et al. Large uremic toxins: an unsolved problem in end-stage kidney disease. Nephrol Dial Transplant. 2018; 33: iii6–iii11.
Colleen Weber, (224) 948-5353
Clare Trachtman, (224) 948-3020