A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Cyberonics

The Continuing CMS Coverage Saga of Cyberonics/LivaNova’s Vagus Nerve Stimulation for Treatment-Resistant Depression

Posted on by Posted in Cyberonics, Depression, LivaNova, Vagus Nerve Stimulation

LivaNova SenTiva VNS
Image Credit: LivaNova

Back in July, 2005, the FDA approved Cyberonics (now LivaNova) VNS implant for patients with chronic or recurrent depression, either unipolar or bipolar, with a history of failure of the depression to respond to at least four antidepressant interventions.

However, the U.S. Centers for Medicare & Medicaid Services (CMS) declined covering VNS for serious depression. CMS concluded back in 2007 that VNS’ effectiveness was not compelling enough to expand coverage, leaving drug-resistant epilepsy as its only covered indication.

Ten years later LivaNova presented data from a five-year study of VNS for treating TRD which showed that patients with chronic moderate to severe TRD experienced anti-depressant effects at a significant rate when treated with the therapy.

In response, last month (February 2019) CMS said:

“Based on the evidence, we believe that VNS for TRD seems promising but not convincing.” “To ensure benefits to Medicare beneficiaries we are proposing to cover VNS for the treatment of TRD when offered in double-blind, randomized, placebo-controlled studies.”

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Cerbomed’s Non-Invasive Vagus Nerve Stimulator Poses Challenge to Implantable VNS Systems

Posted on by Posted in Cerbomed, Cyberonics, Depression, Epilepsy, Inflammation, Pain, Vagus Nerve Stimulation

Cerbomed tVNS non invasive vagus nerve stimulator

Cerbomed GmbH, located in Erlangen, Germany, was founded in 2005 to develop transcutaneous Vagus Nerve Stimulation (t-VNS®) neuromodulation systems.

Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter t-VNS, which is delivered non-invasively to the auricular branch of the vagus nerve (ABVN), making it an attractive therapy option when compared to implantable vagus nerve stimulators.

The NEMOS tVNS system consists of a handheld stimulator and a dedicated ear electrode, which patients wear like an earphone.  According to Cerbomed, intensity, pulse duration and frequency of the t-VNS stimulation have been optimized to induce signals in thick-myelinated Aβ fibres of the ABVN. Like those of the cervical branch of the vagus nerve, these project directly to the nucleus of the solitary tract (NTS) in the brainstem.

In 2010 Cerbomed received the CE mark for its NEMOS® transcutaneous Vagus Nerve Stimulator for the treatment of epilepsy and depression. In 2012, the indication was expanded to include the treatment of pain.

In September 2012, Cerbomed entered into a strategic partnership with Cyberonics, Inc., the global market leader in vagus nerve stimulation.  Cyberonics made an initial investment of €2 million to fund Cerbomed’s epilepsy clinical trial in Germany, with further investments of up to €5.5 million, subject to the achievement of certain clinical milestones. Cyberonics is a minority shareholder with certain rights, including representation on Cerbomed’s advisory board and an exclusive option for worldwide sales and distribution of NEMOS.

 

Cyberonics Reports Record Sales for its Fiscal Q2 2014

Posted on by Posted in AIMD Business, Cyberonics

Cyberonics VNS IPGs www.implantable-device.com David Prutchi PhD

Cyberonics reported $70.1 million in sales for the quarter (fiscal Q2 2014), up around 12% from than $62.9 million booked in the fiscal 2013 second quarter. Net income grew, but at a more moderate pace. It surpassed $13.8 million, versus $13.5 million in net income booked during the same period a year ago.  Operating result highlights for Q2 2014 included:

  • Record worldwide sales of $70.1 million, an increase of 12.0%
  • Record worldwide unit sales of 3,496, an increase of 8.2%
  • Record U.S. net product sales of $57.9 million, an increase of 12.4%
  • Continued strong International unit sales of 978, an increase of 9.8%
  • Income from operations increased by 8.5% to a record $21.9 million

 As a result, Cyberonics boosted its guidance for the rest of the 2014 fiscal year. Net sales are now expected to climb to between $281 million and $285 million, versus the $279 million to $283 million stated in previous guidance.

 

 

 

 

Cyberonics Reports 12.4% Increase in VNS Sales for Fiscal Q1 2014

Posted on by Posted in AIMD Business, Cyberonics, Epilepsy, Vagus Nerve Stimulation

Cyberonics VNS IPGs www.implantable-device.com David Prutchi PhDNet product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement.

According to the Aug. 22, 2013 press release, “operating results for the first quarter of fiscal 2014 compared to the first quarter of fiscal 2013, and other achievements, include:

  • Net product sales of $67.4 million, an increase of 12.4%;
  • Net sales of $68.9 million (including $1.5 million of license revenue), an increase of 14.2%;
  • Worldwide unit sales of 3,354, an increase of 9.8%;
  • Record U.S. net product sales of $56.4 million, an increase of 10.8%;
  • Strong International unit sales of 899, an increase of 20.8%;
  • Adjusted non-GAAP income from operations increased by 21.9% to $21.0 million and adjusted non-GAAP income per diluted share increased by 27.9% to $0.48;¹
  • Share repurchases of $13 million; and
  • Significant progress in three clinical studies, E-36, E-37, and ANTHEM.”

 

NeuroPace’s Responsive Neurostimulator (RNS) for the Treatment of Epilepsy

Posted on by Posted in Cyberonics, Epilepsy, NeuroPace

Image Credit: NeuroPace

NeuroPace is a privately-held company in Mountain View, CA.  Their RNS®  implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy.

Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus. Continue reading→

Cyberonics’ Vagus Nerve Stimulators

Posted on by Posted in Cyberonics, Epilepsy, Vagus Nerve Stimulation

Image credit: Cyberonics

Cyberonics was founded in Houston, TX in 1987 to develop an implantable device for the treatment of epilepsy.  In July 1997, The FDA approved the VNS Therapy System (formerly known as the NCP® NeuroCybernetic Prosthesis System) as an adjunctive epilepsy treatment for adults and children over 12 years of age with partial onset seizures refractory to drugs.

Cyberonics currently markets the VNS Pulse and VNS Demipulse IPGs, which offer approximately 6 years of longevity at nominal stimulation settings (2 mA, 20 Hz, 500 msec, 10% duty cycle into a 4 kOhm load).

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