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.

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. 

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.

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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.

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.

 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.  

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?