Meet with SmartTRAK in Miami!

The American Society of Pain and Neuroscience (ASPN) will be holding
its 6th Annual Conference in Miami Beach from July 11-14, 2024, which
will feature the latest research, cutting-edge updates and discussion on
topics in pain and neuroscience.

SmartTRAK has put together highlights of recent news in SCS, PNS and
minimally invasive spine to catch you up on the “news to know” before
going to ASPN 2024. The following is just a small sampling of recent
news and SmartTRAK updates from around the world compiled,
reviewed and posted in real-time every day by the expert analysts
at SmartTRAK.

SmartTRAK’s Anne Staylor will be getting the scoop on what’s new at
ASPN, and will be available to meet in person at the meeting. If you or
your company have important news you’d like to share, please reach out
to Anne Staylor, SmartTRAK’s Executive Editor and VP & GM, Neuro
Therapies, at anne.staylor@smarttrak.com,

New Products:

• SPR Therapeutics' SPRINT extensa XT System with Bimodal PNS
  

  BSX was issued a US Patent, “Stimulation Modes To Adapt Customized Stimulation Parameters For Use In A Spinal Cord Stimulation System,” describing a graphical user interface to allow a pt to select a stimulation mode and predict optimal SCS parameters for personalized SCS.12017061

•  SiLO TFX* - Aurora Spine*

   Aurora Spine Corp. announced the successful use of SiLO TFX MIS Sacroiliac Joint Fixation Device in over a dozen patients, providing a minimally invasive surgical option for SI joint pain. Aurora estimates market opportunity > $2.3B/yr in the US and expects full launch by mid-year.

•  Inceptiv SCS: Offering Options in a Closed-Loop Device
  

  David Carr, Medtronic’s (MDT) VP and GM of Pain Interventions, discusses the company’s new Inceptiv SCS, what differentiates it from other SCS devices and what it means for MDT and the SCS market in an interview with SmartTRAK. Inceptiv SCS: Offering Options in a Closed-Loop Device

Patents:

• Nevro*

  NVRO’s US Patent Application, "Selective High-Frequency Spinal Cord Modulation For Inhibiting Pain With Reduced Side Effects, And Associated Systems And Methods," was published from 1.5 KHz to ~50 KHz SCS to treat LBP with reduced side effects.20240181258

• INBRAIN Neuroelectronics

  INBRAIN Neuroelectronics’ US Patent Application “SYSTEM FOR NEUROMODULATION APPLICATIONS” was published describing implantable and non-invasive wearable sensor-driven closed-loop neuromodulation systems that allow patient monitoring for PNS, VNS, DBS and SCS therapy. 20240207618

• SPR Therapeutics

  SPR Therapeutics was granted US Patent “Systems And Methods For Treating Shoulder Pain Related To Subacromial Impingement Syndrome” re one-time, continued or periodic PNS to neurological motor points of the posterior and middle deltoid muscles to mediate shoulder pain. 11944809

The proposed MAC LCDs for Skin Substitutes/CTPs was the hot topic of SAWC and will continue to be until the LCDs are finalized. In this article, SmartTRAK highlights new learnings from discussions at SAWC and the MAC open meetings.

The Symposium on Advanced Wound Care (SAWC) Spring 2024 meeting welcomed clinicians, researchers and industry to Orlando, FL, to learn, earn continuing education credits, share knowledge and network on the latest developments in advanced wound care. As is typical during SAWC, the Alliance of Wound Care Stakeholders also held a meeting of their members. With the Medicare Administrative Contractors (MACs) recently announced proposed changes in the Local Coverage Determination (LCD) governing Skin Substitutes/CTPs (cellular and/or tissue-based products), the Alliance pivoted and invited an expert to speak to the group about how the LCD process works and what laws govern what can be done at the MAC level versus the Center for Medicare & Medicaid Services (CMS) levels. Kudos go out to the team at the Alliance for bringing this meeting together. In addition to the Alliance meeting at SAWC, the MACs held open meetings for these LCDs from May 16 to May 29, and anyone, including manufacturers, could present comments, make a request and provide evidence. SmartTRAK participated in several of these meetings.

In this downloadable article, SmartTRAK gives an overview of LCDs, how they are drafted, the coverage limitations by wound type, issues surrounding evidence for inclusion on the covered list and an implementation timeline. For more information on what the proposed LCDs cover, see also “Medicare Administrative Contractors’ (MACs) LCD Changes: Impact on Skin Substitutes/CTPs.”

The following subjects are covered in detail in this downloadable article:

• The Process for Drafting LCDs
  As background, CMS governs the process for drafting the LCDs in their Medicare Program Integrity Manual (PIM) in Chapter 13, which was most recently updated in 2019 with almost every section re-written. These changes include ... (read more)
  
  
• Coverage Limitations
  The LCD is a literal guide to what is allowed and, conversely, what is automatically denied within the limits written in the LCD. The LCDs for Skin Substitutes/CTPs are for ... (read more)
  
  
• Missing or New Evidence and Reconsiderations
  One area that generated the most questions from manufacturers was how to address coverage decisions if the MAC working groups are missing recently published evidence or have evidence currently in development. The comment submission period was ... (read more)
  
  
• Timeline for LCD Implementation
  During the MAC open meetings, participants had several questions regarding the timeline for LCD implementation, and some requested a delay in implementation. The following timeline applies to all LCDs ... (read more)
  
  

" Perspective article by Jay Merkel, SmartTRAK Sr. Analyst.

INS President Dr. Marc Russo and INS President-Elect Dr. Konstantin Slavin discuss the current “state of the union” in neuromodulation, how the field is evolving and the challenges and opportunities that lie ahead in an interview with SmartTRAK at INS 2024.

At the 16th International Neuromodulation Society World Congress (INS 2024) held in Vancouver, Canada, Dr. Marc Russo, INS president, and Dr. Konstantin Slavin, INS president-elect, discussed the current “state of the union” in neuromodulation, how the field is evolving, where it’s going and trends in research, technology and clinical practice in an interview with SmartTRAK. They also discussed challenges and opportunities in the field, how the INS is addressing recent criticisms about neuromodulation and the promise and potential of neuromodulation across a wide range of clinical applications. 

To find out more, including the promising indications and areas of growth for spinal cord stimulation (SCS) and deep brain stimulation (DBS), click on the following video to listen to the interview recorded live at INS 2024 (51:53 min). Click hereto download a complete transcript of the interview. Topics by timecode are provided below. 

SmartTRAK highlights market and technology trends that will help drive growth in neurovascular interventions in 2024.

The neurovascular intervention market is poised for another exciting year in 2024, with key trends driven by an expanding treatable population and innovative technologies addressing critical gaps in patient care. The percentage of eligible acute ischemic stroke (AIS) patients who receive endovascular therapy (EVT) is projected to increase from ~25% in 2022 to ~40% in 2027E. According to the SmartTRAK US Mechanical Thrombectomy Market Overview, the market will generate a 5-year CAGR of 11.1%. Amidst market growth driven by treatment time window expansions, direct-to-EVT protocols and increasing evidence supporting EVT to treat large core stroke patients, SmartTRAK predicts continued advancements in three key areas: aspiration thrombectomy for ischemic stroke, automated stroke detection software and novel devices for treating intracranial aneurysms.

#1: Innovations to Increase Aspiration Efficiency
Aspiration thrombectomy is a mainstay of stroke treatment. With the increasing adoption of A Direct Aspiration, First Pass Technique (ADAPT), companies are innovating to improve aspiration efficiency, effectiveness, procedure speed, reperfusion and patient functional outcomes. SmartTRAK sees ... (read more)

#2 Accelerating Adoption of Automated Stroke Detection Technologies
Early and accurate stroke diagnosis is critical for timely intervention. Automated stroke detection software is gaining traction, with companies like Brainomix, RapidAI and Viz.ai leading the charge. Studies have shown that ... (read more)

#3 Aneurysm Treatment Beyond Flow Diverters
 While flow-diverting stents (FDS) remain a mainstay in treating intracranial aneurysms, SmartTRAK has witnessed the development of more novel devices catering to a broader range of aneurysm types and sizes since MicroVention introduced the Woven EndoBridge (WEB) device in 2011, the first intrasaccular device developed specifically for the treatment of wide-neck bifurcation aneurysms. This trend towards tailored solutions based on ... (read more)

The neurovascular intervention market is on an exciting trajectory, driven by increasing patient populations, innovative technologies and a focus on improving patient outcomes. 2024 promises to be a year of significant advancements in ... (read more)

Just click the button below to download and read the complete "Key Trends in Neurovascular Intervention for 2024" Market Outlook article by  Shelly Caruso, SmartTRAK Market Analyst/Associate Editor.

ISASS’s Morgan Lorio, MD, president-elect, discusses the obstacles to adopting emerging technologies in spine surgery and the importance of advocating for policy changes to support innovative treatments and improve patient outcomes in an interview with SmartTRAK.

Key topics discussed include ISASS’s successful efforts in addressing coding and reimbursement challenges to ensure access to innovative treatments for patients, the potential impact of artificial intelligence (AI) on reimbursement, the new ICD-10 codes for discogenic pain, regenerative spine treatments, future directions and initiatives for ISASS and fostering collaboration between industry stakeholders and surgeon societies.