Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021

HomeBAXTERBaxter Achieves Regulatory Milestone for New Peritoneal Dialysis Technology

Baxter Achieves Regulatory Milestone for New Peritoneal Dialysis Technology


Company States: Innovative home dialysis solution generation system designed to enhance patients’ therapy experience

New system may reduce barriers and offer more patients access to home therapy

Baxter International Inc. (NYSE: BAX), a global innovator in renal care, received guidance from the U.S. Food and Drug Administration (FDA) clarifying the regulatory pathway for an innovative, home peritoneal dialysis (PD) solution system to improve patient access to home dialysis. The new system is designed to produce sterile PD solutions using a small water filtration device that would be placed in the patient’s home and integrated with Baxter’s unique AMIA automated peritoneal dialysis (APD) system with SHARESOURCE telehealth platform. Following FDA guidance, Baxter’s PD solution generation system will follow a regulatory pathway as a combination product, which is the process the agency uses for products that include a device and pharmaceutical component.

Baxter’s home solution system is the first known technology designed to reduce storage and weight handling requirements that come with traditional PD therapy. Today, patients must have space to store approximately a one-month supply of PD solutions, which could be up to 40 boxes, requiring significant storage space in a patient’s home. In addition, each box of PD solution weighs approximately 30 pounds and can present a burden for a patient to lift and carry around the home.

“The FDA’s guidance is a pivotal milestone in advancing our new system forward for use by renal patients in an expedient manner,” said Laura Angelini, general manager of Baxter’s Chronic Renal business. “These technology advancements have the potential to greatly enhance home dialysis therapy for patients by providing solution generation on-demand and eliminating some of the barriers that today may keep patients from the lifestyle benefits that home dialysis offers.”

Baxter plans to have the first patient on therapy with the new system, as part of a clinical trial in 2018. Regulatory submission is expected in 2019.

PD is a self-administered therapy managed at home by end-stage renal disease (ESRD) patients. The therapy works inside the body, using the abdominal lining (peritoneal membrane) as a natural filter to remove toxins from the bloodstream. PD solution dwells in the cavity before draining. The process then repeats itself three to four times during each therapy session. Solutions with higher concentrations of dextrose are sometimes used to remove higher amounts of fluid and waste that can be pulled from the body1.

Baxter’s PD solution generation technology is designed to integrate with AMIA and SHARESOURCE, and allow a physician to tailor the treatment regimen for each patient. Baxter’s new system would provide physicians the flexibility to prescribe different dextrose concentrations for each dwell cycle, depending on each patient’s needs.

Baxter’s AMIA with SHARESOURCE, which won the 2016 Chicago Innovation Award, is now in about 1,700 U.S. patients’ homes, where more than 250,000 PD treatments have been performed, to date. AMIA with SHARESOURCE is the first and only APD system to include patient-centric features that help guide ESRD patients through their home PD therapy, while allowing their healthcare providers to remotely view and manage their treatment progress. Features include voice guidance, a touchscreen control panel and the SHARESOURCE two-way, cloud-based platform.

SHARESOURCE allows healthcare providers to securely view their patients’ recently completed home dialysis-related treatment data, which is automatically collected after each PD session. The healthcare team also has better visibility to any missed treatments, providing the opportunity to proactively address patient compliance and resulting potential clinical issues.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

ProSomnus® Sleep Technologies Adds John E. Remmers, MD, to Leadership Team

Dr. John E. Remmers will provide expert medical and strategic guidance on a range of initiatives, including research and development, regulatory clearances, company strategy, medical education, and clinical investigations.

Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.

Christopher Joyce Joins Miach Orthopaedics as VP & CFO

Christopher Joyce has joined as vice president and chief financial officer, and Kevin Sidow has been appointed to the company’s board of directors.

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF

The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy