Nevro Received FDA Approval of its 10 kHz High-Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy

On July 19, 2021, Nevro Corp. received approval for its Senza System, Nevro’s unique 10 kHz stimulation, to treat chronic pain associated with Painful Diabetic Neuropathy (PDN). The company plans to initiate commercial launch activities in the US under its recently launched HFX™ branding, as HFX™ for PDN.

The Chairman, Chief Executive Officer and President of Nevro, D. Keith Grossman,  “This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and who are unable to find relief with currently available pharmacologic options. We are thrilled that we can now begin commercial launch activities in the US and believe this new indication will be an important driver of the long-term growth of our business for years to come.”

Nevro’s expect a mid-single-digit million revenue support from PDN in 2021, the bulk of which is expected to be generated in the fourth quarter, with wider penetration and a larger revenue contribution expected in 2022 and beyond. 

DelveInsight’s analysis in the report titled, DelveInsight’s Chronic Pain associated with Painful Diabetic Neuropathy – Epidemiology Forecast – 2030 Market Insights, Competitive Landscape and, Market Forecast – 2026, the market size of the Senza Omnia system is estimated to increase to around USD 3,500 million by 2026.

The Late-Breaking Trial Data at TVT Prove Sustained Safety and Performance of WATCHMAN FLX Left Atrial Appendage Closure Device

On July 21, 2021, Boston Scientific published positive 24-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for patients having non-valvular atrial fibrillation (NVAF).

Saibal Kar, study co-principal investigator and interventional cardiologist at Los Robles Regional Medical Center and Bakersfield Heart Hospital, California; said, “These findings demonstrate sustained device performance over two years and reinforce the excellent safety and efficacy profile of the WATCHMAN FLX technology. Building upon the low complication rates and 100% rate of effective LAA closure seen at 12 months, the 3.4% rate of ischemic stroke and systemic embolism at 24 months is very encouraging in this complex, elderly patient population.”

In July 2020, Boston received FDA approval and CE mark in 2019 for next-generation WATCHMAN FLX device, and is used in nearly all implants in the US and Europe in place of the previous-generation device.

The company expects full-year growth versus 2019 on the back of new product launches. According to analyst views, interventional cardiology sales grew at around 7% in the first quarter of 2021 versus 2020 with structural heart franchise WATCHMAN, ACURATE neo2, and SENTINEL. The growth of WATCHMAN franchise was accelerated with the positive physician feedback on FLX device performance. The company is expecting a conversion of 90% to FLX and it will be a multi-billion dollar market. 

NuVasive Introduce Modulus ALIF 3D-Printed Porous Titanium Implant for Anterior Spine Surgery

On July 22, 2021, NuVasive, Inc. commercially launched Modulus ALIF, a 3D-printed porous titanium implant for anterior lumbar interbody fusion (ALIF), in targeted global regions. It is the latest addition to the NuVasive Advanced Materials Science (AMS) portfolio and provides implants and instrumentation designed for both supine ALIF and XALIF procedures.

The executive vice president, Global Business Units at NuVasive, Massimo Calafiore, said, “Modulus ALIF has been one of NuVasive’s most successful clinical evaluations to date with continued surgeon adoption and overwhelmingly positive feedback. This differentiated technology furthers our position to become the market leader in ALIF and extends our Modulus portfolio across all procedural segments. We are leveraging our experience as the leader in lateral surgery to deliver outcome-driven innovation to fuel continued growth and differentiation in the anterior spine segment.”

According to the analysts, the ALIF was the main driver of thoracolumbar improvement, led by Modulus ALIF that was commercially launched on July 22 after positive results from clinical studies. The company has an opportunity of USD 2.6 billion in the cervical cancer segment.

Johnson & Johnson Vision Launches VERITAS Vision System to Address Unmet Needs in Cataract Surgery

On July 23 2021, Johnson & Johnson Vision launched the VERITAS Vision System, a next-generation phacoemulsification system designed to address three critical areas: patient safety, surgeon efficiency, and comfort. The company provided live demos of the new system in a wet lab at the Johnson & Johnson at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting.

Mr Warren Foust, Worldwide President, Surgical at Johnson & Johnson Vision, said, “On top of providing a safe and stable procedure for cataract patients, we wanted to also offer a more efficient and comfortable phacoemulsification experience for surgeons, especially knowing most will perform multiple cataract surgeries every day. Our VERITAS Vision System delivers high-performing, reliable tools for smooth, effective cataract surgery for patients while also prioritizing surgeon wellbeing.”

The system will be accessible for ophthalmologists across the United States, Europe, and select markets in the Asia Pacific region to use in the treatment of cataracts and will be offered later this year in Chile and Brazil.

As per analysts, the company saw growth of 115.8% in global surgical vision in the second quarter of 2021, on the back of market recovery and positive momentum related to new products like TECNIS Eyhance TECNIS Synergy, and VERITAS, our next-generation phacoemulsification device. This is the company’s first phacoemulsifier and has received a positive response.

Medtronic Introduces Newest-Generation Drug-Coated Balloon Catheter in Europe for Treatment of Coronary Artery Disease

On July 26, 2021, Medtronic launched Prevail drug-coated balloon (DCB) Catheter in Europe after getting CE (Conformité Européene) mark. Prevail is the latest coronary DCB available in the market and is used during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease (CAD).

Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, part of the Cardiovascular Portfolio at Medtronic, “The launch of the Prevail DCB not only underscores our global leadership and commitment to interventional cardiologists around the world but also highlights our strong focus on complex PCI. We intentionally designed the Prevail DCB to address the challenges posed by smaller, more complex vessels by leveraging our coronary technologies to provide physicians the ability to navigate through tight lesions with greater confidence.”

The Prevail DCB is the newest addition to the Medtronic coronary portfolio, comprising the market-leading Resolute Onyx DES in sizes ranging from 2-5 mm, the Euphora™ semi-compliant balloon dilatation catheter, the DxTerity™ Diagnostic Angiography Catheter line, and the Telescope™ Guide Extension Catheter.

The DCB catheter is expected to treat more patients with complex lesions and target a large patient pool as it has a low crossing profile for exceptional crossability. The company offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.

The Prevail DCB is available for use in Europe and is not approved in the US.

AngelMed Announces First Commercial Implantation of Real-Time Heart Attack Warning System

On July 27, 2021, Angel Medical Systems, Inc., a proactive diagnostics company focused on advancing the long-term management of high-risk coronary disease, announced the first commercial implantation and the US launch of its flagship product, The Guardian™ device. The implantation marks the Guardian’s first use following its recent FDA approval, indicated for acute coronary syndrome (ACS) events, including silent heart attacks.

This outpatient procedure was performed successfully by cardiac electrophysiologist and cardiologist Dr. Andrew J. Kaplan of Cardiovascular Associates of Mesa in Mesa, Arizona.

Dr. Andrew Kaplan said, “The first commercial implant of The Guardian marks a pivotal advancement in cardiac care. The device detects upcoming ACS events, including silent heart attacks, and leads to earlier patient treatment.”

As per the analysis, the Guardian fills the gap that high-risk ACS patients face, thus, has the potential to target a large market. It has a high acceptance rate even though it is first-in-kind technology as it has clinical success. The device has the ability to provide comfort to both at-risk patients, caregivers, and their healthcare providers as it monitors around the clock.

MeMed obtains CE mark for its Test Predicting COVID-19 Severity

On July 27, 2021, MeMed received the CE mark for its COVID-19 management tool MeMed COVID-19 Severity, which makes use of host response technology to check for various proteins in a serum sample. The test takes 15 minutes to run on the company’s point-of-need platform. It aims to help physicians identify who may benefit from increased care and who may be safely discharged from the hospital and instructed to self-isolate at home.

Eran Eden, MeMed’s co-founder, and CEO said, “I’m excited to begin deploying a pioneering solution to help identify COVID-19 patients at risk of severe outcomes, empowering physicians to manage what is increasingly likely to become an endemic situation. MeMed COVID-19 Severity is also relevant for authorities contemplating preparedness for future pandemics.”

The company intends to provide the test in Europe both directly and through commercial partners.

The analyst expects the MeMed COVID-19 Severity to help doctors assess patients with severe complications, allowing the patients with low risk to be discharged and offer personalized treatment to COVID-19 positive patients. The test is easy to use and provides results in real-time.