St. Jude Medical's Brio DBS system for treating Parkinson’s disease receives Australian TGA approval

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory and reimbursement approval from the Australian Therapeutic Goods Administration (TGA) of its Briodeep brain stimulation (DBS) system for treating the symptoms of Parkinson’s disease.

“Because we recognize that some patients are better served by rechargeable systems and others with non-rechargeable systems, we are pleased to provide physicians with options that allow them to customize systems to match the patient’s needs.”

The Brio neurostimulator is the world’s smallest, longest-lasting rechargeable DBS system. Featuring a thin 10 mm profile, the device is slightly larger than the typical man’s watch and weighs 29 grams (approximately 1 oz). In addition to its small size, the Brio neurostimulator has a 10-year battery life approval -- the longest of any rechargeable DBS device currently on the market.

In addition to the regulatory and reimbursement approval of the Brio DBS system, reimbursement authorization was granted for the Libra and LibraXP non-rechargeable DBS systems, which had received prior TGA approval in 2009.

“The approval of the Brio DBS system in Australia is an exciting addition to our product line that includes the Libra and LibraXP neurostimulators,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “Because we recognize that some patients are better served by rechargeable systems and others with non-rechargeable systems, we are pleased to provide physicians with options that allow them to customize systems to match the patient’s needs.”

The Brio neurostimulator has the greatest implant depth of any rechargeable DBS device available today. The implant depth combined with the device’s thin profile potentially make it less noticeable and more comfortable for patients, while providing physicians with flexibility in selecting the implant location. Additionally, the device is designed with a battery that should provide sustainable therapy while maintaining a reasonable recharge interval for at least 10 years of use at high settings. The device’s battery longevity may also maximize the time between device replacement procedures.

The Brio neurostimulator also features:

  • Ability to accommodate two leads, allowing for bilateral stimulation from one device
  • High power capability, making it an appropriate choice for patients who require high energy settings to control their symptoms
  • A rechargeable battery that can be easily charged through a portable, wireless charging system, allowing patients the freedom to recharge comfortably while doing other activities
  • Constant current circuitry that automatically adjusts to deliver consistent therapy over time

Deep brain stimulation is a therapy that uses mild electrical pulses from an implanted device to stimulate specific targets in the brain. The system consists of a neurostimulator – a surgically implanted battery-operated device that generates the electrical pulses – and leads that carry the pulses to the brain to influence the abnormal nerve signals responsible for the symptoms of Parkinson’s disease.

Parkinson’s disease is a chronic, neurodegenerative movement disorder that progressively diminishes a person’s control over his or her movements. The disease affects approximately 6.3 million people worldwide according to the European Parkinson’s Disease Association.

In addition to the TGA approvals, the Brio, Libra and LibraXP DBS systems have also received CE Mark approval in Europe. In the U.S., the Libra and LibraXP systems are currently being evaluated in clinical studies for depression, Parkinson’s disease and essential tremor. For more information about these studies, visit www.BROADENstudy.com, www.PowerOverPD.com and www.PowerOverET.com.

Source:

St. Jude Medical

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