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Insera Therapeutics takes vacuum aspiration therapy to a new level with a disruptive digital design and cyclical aspiration for mechanical thrombectomy
Insera Therapeutics’ co-founders and brothers Vikram Janardhan and Vallabh Janardhan, MD saw an opportunity in the market for acute ischemic stroke and have developed a next generation, all digital vacuum aspiration system for mechanical thrombectomy designed to take suction aspiration to a new level. Unlike traditional analog electromechanical vacuum aspiration systems, which provide uniform, static aspiration, the Company’s CLEAR Aspiration System allows users to layer cyclical or pulsatile aspiration on top of uniform aspiration. By marrying a computer to a vacuum pump, Insera’s Clear Aspiration System can be finely controlled, and allows users to create their own cyclical wave patterns remotely using an iPad controller.
The Company recently received CE Mark for the Clear Aspiration System with a broad indication beyond stroke, and research to date suggests the technology provides better transmission suction to the tip, improves the first pass effect and decreases emboli in new territory.
To find out more about Insera Therapeutics, the technology and what’s next for the Company, SmartTRAK interviewed CEO Vikram Janardhan and Chief Medical Officer Vallabh Janardhan, MD, at the Society of Neurointerventional Surgery (SNIS) Annual Meeting in Miami Beach, FL held July 22-26, 2019.
Click on the following video to listen to SmartTRAK’s interview with Vikram and Vallabh Janardhan, MD, recorded live at SNIS 2019. To download a transcript of the interview, please click the button at the end of this post.
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In Q219, US and WW spinal cord stimulation (SCS) revenues were down for all the big players against tough YoY comps and ongoing weakness in the market as companies work through a gap in new product introductions, ongoing commercial execution issues and customer destocking. In the US, SCS revenues were down -6.3% vs Q218 according to the SmartTRAK Financial Dashboard. Although revenues were up sequentially per the usual seasonality in Q2, QoQ growth in Q219 was more anemic compared to the previous year. Between Q119-Q219, US SCS revenue was up just over ...
Among the many topics covered in the complete Q219 SCS Market Recap* are:
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SmartTRAK is excited to be attending the Society of Neurointerventional Surgery’s (SNIS) 16th Annual Meeting in Miami, Florida from July 22-25, 2019. Anne Staylor, Managing Editor, Business Intelligence and Senior Director, Advanced Technologies will be covering the latest news at the conference, and will be providing updates on key studies, trends, and technologies affecting the market for ischemic and hemorrhagic stroke devices.
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Intraoperative neuromonitoring could be a game changer in the field of SCS by elucidating the MOA for current and emerging SCS waveforms and stimulation patterns. But will it improve outcomes? To find out more, SmartTRAK interviewed Steven Falowski, MD at NANS 2019.Steven Falowski, MD, Secretary of the Board for the North American Neuromodulation Society (NANS), discusses the latest research on the use of intraoperative neuromonitoring during spinal cord stimulation (SCS) in an interview with SmartTRAK at the NANS 22nd annual meeting held Jan. 17-20, 2019 in Las Vegas.
Historically, pain specialists have always placed spinal cord stimulators in awake patients for safety reasons and to confirm the therapy is adequately covering painful areas. However, Dr. Falowski says there’s been a paradigm shift where both pain physicians and surgeons alike are now using intraoperative neuromonitoring to place SCS systems for both percutaneous electrodes and paddle leads in asleep patients to more accurately localize the spinal cord midline and to improve intraoperative electrode placement and pain coverage...
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In an interview with SmartTRAK, Robert Levy, MD, president of the International Neuromodulation Society (INS), provides a preview of the research, emerging technologies, and trends in neuromodulation that will be at the INS 2019 14th World Congress to be held May 23-30, 2019 in Sydney, Australia.
The meeting will highlight several important topics, including the use of neurostimulation to reduce opioid use, closed-loop neurostimulation, and advances in non-invasive brain stimulation, including for the treatment of post-traumatic stress disorder, depression, and for enhancing memory and learning.
In terms of research, Dr. Levy said Sam Eldabe, MD of the United Kingdom will provide a critical evaluation of clinical trials in neuromodulation. Researchers will also present the latest insight into mechanism of action, new data on neurostimulation for cardiac ischemia, as well as research on use of deep brain stimulation (DBS) for obesity, eating disorders and addiction. Researchers will also present important pivotal trial results, including: the Evoke Study (Saluda Medical), evaluating closed-loop spinal cord stimulation (SCS); the SURF study (Stimwave Technologies), comparing different wireless SCS frequencies and waveforms; and the ReActiv8 trial (Mainstay Medical), evaluating the use of a restorative neurostimulation system for nocioceptive chronic low back pain.
On the technology front, the INS’s Innovation Day will highlight disruptive innovations in neuromodulation, and will feature panel discussions and presentations by researchers and major shareholders from early stage start-ups, middle-stage start-ups and well-established companies.
To find out more about the INS World Congress, click on the following video to listen to SmartTRAK’s interview with Dr. Levy recorded via phone from his office in Florida. A transcript of the interview is also provided below.
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This informative article also includes exclusive interviews with leading figures in Neuromodulation including Saluda Medical CEO John Parker, President Abbott Neuromodulation Keith Boetigger, Medtronic Senior VP and Pain Therapies President Marshall Stanton, and Medtronic Senior Global Product Manager for Pain Stimulation and Early Interventions Brian Ranck ...
Spotlight on Saluda Medical
In one of the most anticipated presentations at NANS 2019, Nagy Mekail, MD, PhD presented preliminary three-month results from Saluda Medical’s EVOKE US pivotal RCT (N=134), which is evaluating Saluda’s ECAP-controlled, closed-loop, Evoke SCS System. In the double-blinded study, the experimental arm (n=67) received closed-loop Evoke stimulation while the control arm (n=67) received fixed-output, open-loop Evoke SCS stimulation. At three months, the closed-loop group demonstrated superiority (Ps=0.005) having an 82.3% (51/62) success rate vs the open-loop group’s 60.3% (38/63) in 50% or greater reduction in overall Trunk and Limb VAS. The closed-loop group also met superiority (Ps=0.003) in terms of low back pain responders at three months with 80.6% demonstrating a 50% or greater reduction in back VAS versus 57.1% in the open-loop group. Of note, the closed loop Evoke group spent 91.1% of time (median % of stimuli) within the therapeutic window vs 59.5% of the time in the open-loop group.
In another presentation, Charles Brooker, MBChB presented updated results from the ongoing AVALON trial evaluating the safety and performance of
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The US SCS Market saw another banner year in FY18, growing +17.4% YoY. Market growth was driven by new product launches, expanding indications and ongoing demand for non-narcotic alternatives that address chronic intractable pain and the opioid epidemic.
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SmartTRAK reports that with new products providing a strong tailwind in Q318, the SCS market saw another quarter of strong double-digit growth in both the US and WW, positioning the market for another record year.
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SmartTRAK identifies trends to watch in spinal cord stimulation
With the start of a new year, it's time to look back at 2018 and identify continuing and emerging trends in the market for Spinal Cord Stimulation (SCS) that are likely to shape the landscape in 2019 and beyond.
So what’s on the horizon? Anne Staylor, SmartTRAK Managing Editor, gives her predictions for the top technology and market trends to watch.
Among the many interesting and informative topics covered in the article are: