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UCSF artificial kidney project tapped for accelerated FDA program - Medical Xpress PDF Print

The FDA announced today (April 9) that it had chosen three renal device projects to pilot a new regulatory approval program called Innovation Pathway 2.0, intended to bring breakthrough medical device technologies to patients faster and more efficiently.

The artificial kidney project, which is targeted for clinical trials in 2017, was selected for its transformative potential in treating end stage renal disease and for its potential to benefit from early interactions with the FDA in the approval process.

The FDA effort will involve close contact between the federal agency and device developers early in the development process to identify and address potential scientific and regulatory hurdles and create a roadmap for project approval. The goal is to improve the projects' overall chance of success, while reducing the time and cost of FDA review and maintaining safety. Lessons, the agency said, will inform approvals in other areas.

UCSF artificial kidney project tapped for accelerated FDA program
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This is a model of the implantable bioartificial kidney shows the two-stage system. Thousands of nanoscale filters remove toxins from the blood, while a BioCartridge of renal tubule cells mimics the metabolic and water-balance roles of the human kidney. Credit: UCSF

The artificial kidney project has brought together 40 researchers in nine laboratories nationwide under the guidance of Shuvo Roy, PhD, a on the faculty of the UCSF School of Pharmacy. It aims to combine nano-scale engineering with the most recent advances in to create an that would enable patients with to lead healthier and more productive lives, without external dialysis or immune suppressant medication.

"The new Pathway program is a clear signal to researchers that innovations in how we treat disease are needed and supported by the FDA," said Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy. "We're so pleased the Kidney Project is in the vanguard as the program launches."

End-stage renal disease, or chronic kidney failure, affects nearly 2 million people worldwide, including more than 570,000 in the United States, and costs the nation almost $40 billion each year for treatment. The most effective treatment is kidney transplantation, but those organs are in short supply; last year, only 16,812 kidneys were available for transplant, leaving 92,000 patients on the waiting list, according to the Organ Procurement ant Transplant Network.

For projects like the artificial kidney, inclusion in the program could also build confidence among investors.

"This will help us with investors and funding agencies," said Roy, who has met with several possible investors and granting agencies to fund the expected $20 million it will cost to bring the artificial kidney through clinical trials. "One of the questions we always get is, 'How will the FDA handle this?' With the Innovative Pathway program, we will know the answer to that question."

The UCSF , or implantable Renal Assist Device (iRAD) would include thousands of microscopic filters as well as a bioreactor to mimic the metabolic and water-balancing roles of a real kidney.

The combined treatment has been proven to work for the sickest patients using a room-sized external model developed by a team member at the University of Michigan. Roy's goal is to apply silicon fabrication technology, along with specially engineered compartments for live kidney cells, to shrink that large-scale technology into a device the size of a coffee cup. The device would then be implanted in the body, allowing the patient to live a more normal life.

Provided by University of California, San Francisco (news : web)

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Continuous Mortality Risk Among Peritoneal Dialysis Patients - Archives of Internal Medicine PDF Print

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Use of Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor ... - Archives of Internal Medicine PDF Print

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Sunday's Our View: Harnessing the cost of health care - SW Iowa News PDF Print

Some will consider the announcement a turning point – a watershed event – in health care. Nine medical societies representing nearly 375,000 physicians joined forces to challenge the widely held perception that more health care is automatically better.

The medical groups that participated are: American Academy of Allergy, Asthma & Immunology, American Academy of Family Physicians, American College of Cardiology, American College of Physicians, American College of Radiology, American Gastroenterological Association, American Society of Clinical Oncology, American Society of Nephrology and American Society of Nuclear Cardiology.

Last Wednesday they released lists of tests and treatments their members should no longer order automatically. Key to the recommendations is that word “automatically.”

The 45 items listed – five from each of the organizations – included most repeat colonoscopies within 10 years of a first such test, early imaging for most back pain, brain scans for patients who fainted but didn’t have seizures and antibiotics for mild-to-moderate sinus distress.

Also on the list: Heart imaging stress tests for patients without coronary symptoms. A particularly sobering recommendation calls for cancer doctors to stop treating tumors in end-stage patients who have not responded to multiple therapies and are ineligible for experimental treatments.

Dr. Christine Cassel, president of the American Board of Internal Medicine, told the Associated Press the goal is to reduce wasteful spending without harming patients. She suggested some patients might actually benefit from the recommendations by avoiding known risks associated with medical tests, such as exposure to radiation.

“We all know there is overuse and waste in the system, so let’s have the doctors take responsibility for that and look at the things that are overused,” said Cassel. “We’re doing this because we think we don’t need to ration health care if we get rid of waste.” Her group sets standards and oversees board certification for many medical specialties.

Dr. James Fasules of the American College of Cardiology said the goal is to begin changing attitudes among patients and doctors.

“We kind of have a general feeling that if you don’t get a test, you haven’t been cared for well,” said Fasules. “That has permeated American culture now.”

The new advice isn’t meant to override a doctor’s judgment, Fasules added, but to inform and support decisions.

Eight other medical societies are developing additional recommendations.

The medical societies don’t have any power of enforcement, and fear of malpractice lawsuits – as much a part of the American culture as the notion that testing is the benchmark of good medical care – may well prompt many doctors to keep ordering as many tests as ever.

Unfortunately, that fear of malpractice may negate the positive efforts of the various medical societies.

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News Woodstock Region - Woodstock Sentinel Review PDF Print

Six local dialysis patients will no longer have to travel to London for life-saving kidney treatment.

 

Woodstock Hospital announced last week that they have expanded dialysis care by three stations.

The additional capacity will increase the Woodstock dialysis unit to nine stations, increasing care from 30 to 36 patients.

“The ability to increase the number of dialysis treatments that we can provide is a real blessing to our community,” said Randy Hicks, director of critical care and dialysis. “Our patients’ experience long days when undergoing dialysis and being able to receive care, close to home reduces stress and allows patients to lead a fuller life.”

A satellite of London Health Sciences Centre, the unit provides hemodialysis treatment for people with chronic kidney disease.

Many of the unit’s patients are waiting for kidney transplants, with others may require dialysis for the rest of their life.

The unit operates six days a week, administering 4,430 treatments year.

Dialysis treatment can take up to five hours, three times per week.

Carol Rhiger, regional director of the Ontario Renal Network for the Southwest Local Health Integration Network, said additional dialysis capacity was needed to address current and future chronic kidney disease in the region.

“This funding will help area patients with chronic kidney disease by easing time, travel, cost and inconvenience of receiving care outside their community,” she said.

Woodstock Hospital, located on Juliana Drive, opened on Nov. 20, 2011 with six-dialysis chairs, but with the capacity to grow to up to 12 chairs.

 

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