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SmartTRAK Life Sciences News and Analysis Blog

3 min read

Showcasing Direct Anterior Hip Solutions at AAHKS 2024

By Lisa Mahan on 12/17/24 6:06 PM

The popularity of direct anterior approach THA is driving new product introductions.

With the exploding growth of enabling technology, much of the focus on implant solutions in recent years has been on knee replacement systems compatible with enabling technologies. At the same time, minimally invasive techniques for hip replacement using the direct anterior approach (DAA) have rapidly been gaining favor among surgeons. More companies are designing implant solutions to facilitate DAA, for use with and without enabling technologies. At this year’s American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting, manufacturers were showcasing not one, but four new hip systems specifically designed to facilitate the direct anterior approach. Because surgeon adoption of this technique appears to be accelerating, it is potentially a significant opportunity for implant companies. In a 2022 survey of its members, AAHKS found that DAA was the most utilized for primary total hip arthroplasty THA (56%), a significant increase from 2018 when 40% of AAHKS surgeons indicated they used an anterior approach.

The introduction of these new stems almost plays out like a David vs Goliath story with two smaller US market players, NextStep Arthropedix and Corin, facing two of the four largest, Zimmer Biomet and Smith+Nephew. In this downloadable article, SmartTRAK looks at these new stems hitting the US market, including a brief history of the stems, their features and benefits, and the market positioning for each.

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3 min read

Facing the Payback Crisis: Challenges Threatening Italy’s Medical Device Sector

By Anikó Szekér on 12/17/24 6:05 PM

In an interview with SmartTRAK, Gennaro Broya de Lucia, president of the National Board of Directors at PMI Sanità, offers a comprehensive summary of the challenges for the medical device market in Italy, which places hundreds of companies at risk in the country.

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2 min read

Pioneering the Future: Inside the World's First Arthroscopic Surgical Robot

By Andy Knapik on 12/17/24 6:00 PM

Dr. Chris Jeffery, founder and CEO of Convergence Medical, discusses the V01, the world's first arthroscopic surgical robot.

In a recent interview with SmartTRAK, Dr. Chris Jeffery, the founder and CEO of Convergence Medical, discussed the V01, the world’s first dedicated arthroscopic surgical robot. In the interview, Dr. Jeffery shared insights into the V01’s novel design, business model, and technological advancements that position it as the next evolution in arthroscopic innovation. The V01 received FDA breakthrough designation in 2023 and is on track for FDA clearance and a US launch in late 2025.

Click on the following video to watch the interview (59:11 min). A complete transcript of the interview is available here. For more details, interview topics by timecode are provided below.


Interview Topics By Timecode:

  • 00:50 Dr Jeffery’s background.
  • 10:00 V01 overview.
  • 20:25 Performing a repair with the V01.
  • 26:50 V01 cost.
  • 36:10 Surgeon feedback.
  • 40:10 Importance of an arthroscopy-specific robot.
  • 42:40 Novel design of the V01.
  • 44:45 Commercial path.

Click the button below to download a complete transcript of SmartTRAK's interview with Dr. Chris Jeffrey, CEO of Convergence Medical Sciences, conducted by Andy Knapik, Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies.

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4 min read

Reimbursement Changes: Wound Dressings Under Threat in Germany

By Anikó Szekér on 10/1/24 9:30 AM

In an interview with SmartTRAK, Dr. Willi Schnorpfeil, an expert in reimbursement strategies, offers a comprehensive overview of the regulatory changes for advanced wound care products in Germany, which pose a potential threat to both market stability and patient care.

In an interview with SmartTRAK, Dr. Willi Schnorpfeil, managing partner of Value & Dossier and Reimbursement Specialist, provides insights into the scope, impact and potential future developments of changes in Germany’s reimbursement landscape, specifically concerning the Advanced Wound Dressing Market. Dr. Schnorpfeil highlights the challenges faced by the industry in meeting new evidence requirements and the possible implications for patient outcomes. This conversation sheds light on the complex regulatory environment in Germany and its broader implications for the healthcare sector across Europe.

Click on the video below to listen to SmartTRAK’s interview with Dr. Schnorpfeil (24:18 minutes), which was recorded on August 22. A link to download the complete transcript of the interview is also provided below. 

 

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2 min read

Trends and Developments in Spine Enabling Technologies at NASS 2024

By Thomas Wallick on 9/24/24 9:36 AM

SmartTRAK is attending the upcoming North American Spine Society (NASS) meeting being held Sept. 25-28 in Chicago, Our team can't wait to see all of our colleagues at the premier meeting for the spine market. To help you get ready for the meeting, in the following video, Elise Wolf, SmartTRAK's VP & GM of Orthopedics and Digital, reviews the latest trends and developments in the Spine Enabling Technologies market.



If you would like to see more of what SmartTRAK has to offer in spine coverage, including some of our recent articles on the trends and developments in the Spine Enabling Technologies market, or if you would like to meet with us at NASS 2024 in Chicago,  just click the button below.

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3 min read

Medtronic: Transforming DBS Therapy - An Interview with Amaza Reitmeier

By Anne Staylor on 9/4/24 9:45 AM

Amaza Reitmeier, Medtronic’s VP and GM of Brain Modulation, discusses the company’s recent FDA approvals for asleep DBS and expanded MRI labeling, and provides an update on adaptive DBS in an interview with SmartTRAK. 

In an interview with SmartTRAK, Medtronic’s Amaza Reitmeier, vice president and general manager of Brain Modulation, discusses the company’s recent news in deep brain stimulation (DBS), including FDA approval for asleep DBS and MRI expanded labeling that allows patients to undergo additional scan time. She also provides an update on adaptive DBS (aDBS) and the ADAPT-PD trial, which is expected to support the global regulatory submissions to commercialize aDBS in patients with PD.  Medtronic recently filed for US FDA approval of aDBS.

Click on the following video to listen to the interview (14:32 minutes). A link to download a complete transcript of the interview is also provided below.
 


Interview Transcript

SmartTRAK: Hey everybody. Anne Staylor here with SmartTRAK. Today I get to talk to Amaza Reitmeier, the vice president and general manager of Brain Modulation at Medtronic. Hey Amaza, thanks for talking with me.

Amaza Reitmeier: Hi, Anne. Great to see you.

I know that you have some big news around DBS. You guys are advancing pretty quickly. The latest news involves FDA approval for asleep vs awake DBS, MRI expanded labeling, and then maybe you could give me an update on some other aspects of the adaptive DBS. So let's get started.

AR: Fantastic.

What is the significance? Talk a little bit about the FDA approval for asleep vs awake DBS, and why is that important? A lot of people are doing that. Just talk a little bit about the significance of that and what it means for Medtronic.

AR:
Thank you, Anne. Well, first and foremost, you know from our prior conversations that we're very focused on the patient and making sure that patients have the best options available to them. While you're right that asleep DBS has been being done for years, it's actually been contraindicated in our labeling. The original labeling for DBS, which was established decades ago, required test stimulation to confirm that the therapy was working. But we also know that ...

Click the button below to download and read the full transcript of the SmartTRAK perspective article "Transforming DBS Therapy - An Interview with Amaza Reitmeier" conducted by Anne Staylor, SmartTRAK's Executive Editor and VP & GM of Neuro Therapies. Download the Transcript

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3 min read

Skin Substitute Market Rocked by DOJ Investigations

By Susan Paquette on 8/7/24 10:59 AM

SmartTRAK believes the billions of dollars of Medicare abuse already uncovered is the tip of the iceberg in services billed to Medicare via the Physician Fee Schedule.

 In June, the Department of Justice (DOJ)   announced  the 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants, including 76 doctors, nurse practitioners, and other licensed medical professionals in 32 federal districts across the US, for their alleged participation in various healthcare fraud schemes. Of these, four defendants were charged in a scheme involving amniotic tissue to treat chronic wounds.

Arrests were made at the Phoenix Sky Harbor airport in June when two individuals attempting to flee the country were charged by the DOJ for defrauding Medicare over $900.0MM. According to the DOJ case summary, the two individuals “were charged by indictment with various counts of conspiracy, health care fraud, receiving kickbacks, and money laundering in connection with an alleged scheme to fraudulently bill Medicare $900 million for highly expensive amniotic allografts. The defendants targeted elderly Medicare patients, many of whom were terminally ill in hospice care, through their companies—Apex Mobile Medical LLC, Apex Medical LLC, Viking Medical Consultants LLC, and APX Mobile Medical LLC. “

SmartTRAK believes these charges are just the tip of the iceberg in terms of the amount of fraud occurring in the US Market for Skin Substitutes. With a dramatic spike in Medicare claims in 2023, it’s clear widespread Medicare abuse has allowed the US Skin Substitute market to balloon, almost doubling in just one year! The abuse is primarily limited to amniotic tissue products, which held 52.5% of the US market in 2022 and 64.5% of the market in 2023.

In this downloadable article, SmartTRAK discusses in detail the DOJ investigation and its impact on the Skin Substitute market, including:

  • SmartTRAK Financial Analysis of the Market
  • The Impact on Established Market
  • Potential Drivers for Change
  • Criteria for Medicare Physician Fee Schedule Focused (MPFS) Players
  • What Could Impact the Market
  • What the Future Holds

Click the button below to download and read the complete "Skin Substitute Market Rocked by DOJ Investigations" article by Susan Paquette, SmartTRAK VP & General Manager, Wound.   Read the Article

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8 min read

Clues Point to Acetabular Reconstruction

By Lisa Mahan on 7/30/24 9:45 AM

Clue s AcetabularRecent patent applications reveal an industry focus on developing acetabular solutions

While enabling technologies in joint replacement continue to be in the spotlight, clues revealed in the shadows of data point to niche focus areas for hip implant advancements. After examining the evidence in US patent applications filed since the beginning of the year, SmartTRAK identified a trend towards acetabular implant solutions. These solutions include implant designs that can address or potentially reduce the risk of acetabular bone loss or instability, often encountered in revision hip arthroplasty.

SmartTRAK’s US Hip Replacement Market Overview points out that revision hip procedure growth remains lower than that for primary hips due to the extended implant survivorship of next-generation implants and materials. However, revision hip procedures are expected to grow with a 5-year CAGR of +3.5% to nearly 110K procedures by the end of 2028. And, according to a paper by Sahil A. Sanghavi, MS, DNB, et al., acetabular bone loss continues to be one of the most challenging issues faced by orthopedic surgeons. (J Am Acad Orthop Surg, May 2024).

At least 15 patent applications published since January 1 are related to acetabular implant solutions. The line-up of patent subjects ranges from trial implants for more accurate cup placement during surgery to custom 3D printed augments with filings from large market players to designing surgeons. In Figure 1 below, SmartTRAK outlines the most recent acetabular implant-related patent applications.

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5 min read

ASPN 2024: SmartTRAK's Interview with Tim Deer, MD

By Anne Staylor on 7/16/24 8:41 PM

ASPN Chairman Tim Deer, MD, discusses the research and innovation at ASPN 2024 and the society’s collaborative approach to improving care for patients with chronic intractable pain in an interview with SmartTRAK.

Timothy R. Deer, MD, chairman of the American Society of Pain and Neuroscience (ASPN), discusses the society's goals, its rapid growth, and how ASPN is collaborating with different stakeholders to improve patient care and offer a wider range of new and innovative treatment options for patients with chronic intractable pain. To find out more, including what’s new in neuromodulation, minimally invasive spine and regenerative medicine, listen to the following video recorded live at the ASPN 2024 Annual Conference held July 11-14, 2024 in Miami Beach, FL. A link to download the complete transcript of the interview is also provided below. 


SmartTRAK: Anne Staylor here with SmartTRAK. I'm at the beautiful Fontainebleau Hotel in balmy Miami Beach, Florida at the American Society of Pain and Neuroscience Annual Conference. Today is the last day of the conference and I have the pleasure of talking with Dr. Tim Deer, the chairman of ASPN. Dr. Deer, thank you for talking with me today.

Dr. Tim Deer: Anne, thank you so much for having me. It's a great pleasure to talk to you and thank you for coming to our meeting.

Yes. Well, as you know, I think three years ago was the last time I was at your meeting, and I've had a colleague cover it who lives on the East Coast since then. Now I'm back covering the meeting and wow, has it grown exponentially since you and Dr. Sayed co-founded this meeting. I think this year, there's been a lot of energy and vibrancy around the content and in the exhibit hall and honestly, there's so much news for me to cover.

But before we get into the meeting, I thought it'd be a good idea to have you start by talking about the meeting itself, how it's grown, what the attendance has been this year, et cetera. And then what have been some of the key goals of society? And what have you and your vice chair, Dr. Sayed, been working toward as a society since you established the meeting?

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2 min read

M&A in the Total Joints Market

By Lisa Mahan on 6/25/24 9:45 AM

Companies riding the wave of tuck-in acquisitions.

While the chances are relatively low that the Total Joints Market will see a tsunami-size merger in 2024 that would materially change the market landscape, SmartTRAK expects to see a ripple effect from companies that continue to seek out mergers and acquisition (M&A) deals despite the challenging economic climate. Since the beginning of 2023, deals that had a more subtle effect on the market include those providing expanded international reach or initial entrance into the market. In this downloadable article, SmartTRAK highlights the acquisitions taking place since the beginning of 2023 and outlines the sentiment of some of the major companies towards future M&A. SmartTRAK also looks at what may be coming for the top Total Joints Market players, including Zimmer Biomet, Stryker, J&J/DePuy Synthes and Smith+Nephew, as they continue riding the wave of tuck-in acquisitions ...

Just click the button below to read the complete "M&A in the Total Joints Market" perspective article written by Lisa Mahan, SmartTRAK VP Product Development & IT, Sr. Analyst Total Joints. Read the Article


SmartTRAK is the Medtech industry’s only global Insights-as-a-Service solution for the Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapy markets. SmartTRAK’s propriety methodology turns disparate data from hundreds of sources into powerful insights customers can rely on as the trusted source for strategic decision-making. The SmartTRAK enterprise platform includes rich daily updates, comprehensive market coverage and simple-to-use tools and dashboards for market, product and financial analysis. Customers leveraging the SmartTRAK platform also have direct access to market experts for inquiries and advisory services. If you would like a demo of what SmartTRAK offers and how we can help increase proficiency, improve productivity and reduce costs for your company, just click here.

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