SmartTRAK highlights four key trends to watch in orthopedic enabling tech displayed at the 2024 AAOS and Canaccord Genuity Musculoskeletal Conferences.

Enabling technology was a hot topic of discussion at the 2024 Canaccord Genuity (CG) Musculoskeletal Conference and was a big focus at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco, California.   SmartTRAK  highlights four key trends noted at the meetings and expected through 2024 and beyond in orthopedic enabling tech and reports on key news from 17 companies in this space, ranging from multinational strategics to start-ups.

 

SmartTRAK's four key trends to watch in orthopedic enabling tech, which are discussed in detail in this downloadable Market Outlook article, are: 

• • Continued Growth in Ortho Robotics 
    • Similar to the last several years, robotics continued to be a large focus of orthopedic enabling tech at this year’s meetings, with SmartTRAK projecting ... (read more)
      
  • Navigation Targeted to ASC
    • Newer navigation technologies are overcoming the hurdles of traditional navigation systems and are making headway into the ASCs with designs targeted specifically to ... (read more)
  • Augmented Reality Gaining Traction
    • Intraoperative augmented reality continued to be an area of interest at the AAOS and Canaccord meetings this year, and SmartTRAK noted an ever-expanding number of ... (read more)
      
  • Advances in Smart Implants
    • Smart implants will continue to advance in 2024 as companies launch new products and work toward expanded applications. In addition to next-generation knee robotics and partial cementless knees ... (read more).
      

Click the button below to download and read the complete "Orthopedic Enabling Tech Trends at AAOS and Beyond" Market Outlook article by Elise Wolf, GM & VP, SmartTRAK Orthopedics, Digital & Quality.

All seven MACs, in a united front, released proposed changes to the LCDs, which govern Skin Substitute/CTP use for DFUs and VLUs. SmartTRAK looks at the potential impact on the market.

A long-awaited update to Medicare coverage for skin substitutes has arrived. On April 25, 2024, all seven MACs issued the same proposed Local Coverage Determination (LCD) governing the use of skin substitutes/CTPs for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). For seasoned SmartTRAK subscribers, the decision to release an updated LCD was not a surprise. Several of the MAC directors have openly discussed tackling the LCDs. In 2022, a few of the MACs issued a different proposal, and in August of 2023, three MACs issued a final LCD governing skin substitutes for implementation later in 2023, only to be rescinded days before the effective date. In August 2023,  SmartTRAK published an article, " Impact of Medicare Administrative Contractor LCD Changes on Skin Substitutes/CTP Changes," discussing the potential impact of those earlier attempts.

Since the article was published last year, SmartTRAK has identified explosive market growth in some new care sites and added a new category, Mobile+, for expanded coverage. 

In this downloadable article, SmartTRAK delves into Mobile+, the key provisions in the proposed LCDs, patients affected and the estimated financial impact on the market, including:

• Key Policy Changes
  • One of the key limitations of these LCDs is the number of product applications. Previous LCDs often had a ... (read more)
• Impact on Patients
  
  • With the united front from all the MACs, this LCD will impact all traditional Medicare patients across the US. Patients enrolled in Medicare Advantage plans are also impacted by ... read more)
• Market Impact
  
  • By reviewing the LCD coverage changes and mapping them to the various sites of care that have varying payment models, SmartTRAK sees ... (read more)
• Links to LCDs and Articles from the CMS Announcement
• List of Covered Products with Companies and Ulcer Sizes

  

Just click the button below to download and read the complete "Medicare Administrative Contractors' (MACs) LCD Changes: Impact on Skin Substitutes/CTPs" Perspective article by Susan Paquette, SmartTRAK VP & General Manager, Wound and Jay Merkel, SmartTRAK Sr. Analyst, Wound.

New leadership at Vaporox to launch a second generation of vaporous hyperoxia therapy at SAWC Spring 2024.

With the upcoming launch of its second-generation Vaporous Hyperoxia Therapy (VHT-200), Denver, CO-based Vaporox is well positioned to treat a wide range of chronic, hard-to-heal wounds and expand the company’s presence in the almost five billion dollar US Market for Advanced Wound Care. SmartTRAK spotlights the company, its latest research and VHT, a breakthrough technology designed to accelerate wound healing when combined with standard or advanced wound care.

In this comprehensive SmartTRAK Perspective article, available for download, we delve deep into Vaporox, exploring a variety of detailed topics, including:

• The Overview
  Vaporox CEO and President Alan Sage, a successful start-up entrepreneur, brings his decades of experience to the medical device industry to bring VHT-200 to market. The novel technology was developed as a result of work at UCLA Medical Center for children with debilitating bed sores ...
  
• Technology/Key Differentiator
  VHT delivers a unique combination of elements that accelerate healing: ultrasonic mist and concentrated oxygen. Vaporox administers these elements in a patented, automated, dual-modality system ...
  
• Market Potential  
  After starting in the diabetic foot ulcer (DFU) space, the company has quickly expanded into facilities treating all types of wounds, including venous leg ulcers (VLUs), dehisced post-surgical wounds, burns and pressure injuries ...
• Business Model/Financing
  The Vaporox business model provides the device to the clinician at no cost and charges for the disposable and pay-per-use fees ...
  
•  Clinical/Regulatory Status 
  Vaporox received FDA 510(k) clearance for the second-generation VHT-200 product in the spring of 2023 ...
  
• Reimbursement
  VHT is a low-frequency, non-contact, non-thermal ultrasonic mist therapy. It is an FDA-cleared technology that has been clinically validated as a safe and effective adjunctive treatment for healing nine types of skin wounds ...
  
• Goals
  The company just hired a new vice president of sales and marketing and is aggressively pursuing high-volume private-practice podiatric surgeons, medical doctors, and nursing facilities ...
  

To download and read the complete "Vaporox Company Spotlight" perspective article by Susan Paquette, SmartTRAK VP & General Manager, Wound, just click the button below.

Medtronic’s David Carr, VP & GM, Pain Interventions, discusses Inceptiv closed-loop SCS in an interview with SmartTRAK.

Medtronic (MDT) announced FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS), the second closed-loop SCS device to reach the market using evoked compound action potentials (ECAPS). The company previously launched Inceptiv in Europe and Japan and plans to initiate Inceptiv’s US market launch in the coming weeks. 

SmartTRAK recently interviewed David Carr, MDT’s vice president and general manager of Pain Interventions, to learn more about Inceptiv, what differentiates it from other SCS devices and what it means for Medtronic and the SCS market. To listen to the interview, click on the following video (22:54 min). A link to download the complete transcript of the interview is also provided below. 

Anne Staylor here with BiomedGPS. Today, I am talking with David Carr, who is the vice president and general manager of Pain Interventions at Medtronic. Exciting news, David. Medtronic now has FDA approval for your Inceptiv SCS device, an ECAPs-based device. So David, tell me what does Inceptiv mean for Medtronic?

David Carr: Good afternoon, Anne, and thank you for your time today and your interest in this announcement for us. This is a big moment for Medtronic and especially for the pain team within Medtronic. This is technology that has taken many, many years to develop. If you think back to the pivotal RCT, we did ECHOMAC, which demonstrated the performance of closed-loop technology, the algorithm, many years ago. Six published manuscripts across many recognized journals. Twenty peer-reviewed abstracts and posters, data from over 200 patients and several million ECAPs. So this is not something that's just been developed in the last couple of years. There's been a tremendous amount of work invested in this platform. So this is a very big moment for Medtronic, finally getting approval with the FDA to launch the product in the US market. Because as you know, we've already launched this product in Europe and Japan, and we're already seeing the tremendous patient benefits that the product brings to the market.

Let's start by having you talk about the technology itself. What are the key differentiators for Inceptiv versus other ECAPs-based devices on the market?

DC: Well, there's only one other ECAP-based product on the market, and that product is essentially closed-loop paresthesia. Okay, what differentiates this product is ...

To download and read the complete interview "Inceptiv SCS: Offering Options in a Closed-Loop Device" with David Carr, VP and GM of Pain Interventions at Medtronic, just click the button below.

SmartTRAK highlights three innovative start-ups with next-gen spine robots in development: Cyber Surgery, LEM Surgical and SpinEM Robotics.

The landscape of spine robotics has undergone a remarkable transformation in recent years, with advancements in technology revolutionizing the approach to spinal surgeries. As we step into 2024, there’s a race in the Spine Enabling Technology Market among companies to develop state-of-the-art robotic systems. The demand for minimally invasive spinal surgeries has been a driving force in the evolution of spine-enabling technologies.