FDA Cleared Oral Device for Severe Sleep Apnea From Vivos Therapeutics

On November 29, 2023, Vivos Therapeutics announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vivos’s removable CARE (Complete Airway Repositioning and Expansion) oral appliances developed for treating severe obstructive sleep apnea (OSA).

With this FDA approval, Vivos Therapeutics became the first firm to approve and launch a viable therapy option for patients suffering with severe OSA other than CPAP or surgical neuro-stimulation implants. This latest approval marks the first time the FDA has ever approved an oral device to treat moderate and severe OSA in adults 18 years of age and older in conjunction with positive airway pressure (PAP) and/or myofunctional therapy.

Kirk Huntsman, Chairman and CEO of Vivos, stated, “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neuro-stimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention. Vivos trained providers can now treat patients with OSA and conditions associated with OSA comprehensively using our suite of FDA cleared devices, without regard to the severity of their OSA condition and across a range of price point options,” continued Mr. Huntsman. “We believe this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for Vivos treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals. We also believe it will enhance our value proposition to third-party distribution partners such as durable medical equipment (DME) companies. This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare. We believe that all these factors should favorably impact our ability to grow our revenues in 2024 and beyond.”

According to DelveInsight’s “Sleep Apnea Devices Market” report, the global sleep apnea devices market was valued at USD 7.53 billion in 2022, growing at a CAGR of 6.26% during the forecast period from 2023 to 2028 to reach USD 10.82 billion by 2028. The demand for sleep apnea devices is primarily being boosted due to the increasing cases of sleep apnea, and the rising population with obesity. Further, the rising adoption of advanced and innovative technologies, the rising awareness about sleep apnea devices, the increasing geriatric population, and the increasing product launches and approvals, among others is expected to propel the market for sleep apnea devices.

Johnson & Johnson Medtech Acquired Laminar, Inc.

On November 30, 2023, Johnson & Johnson Medtech, acquired Laminar, Inc. a privately-held medical device company focused on eliminating the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib). 

Subject to usual adjustments, Johnson & Johnson MedTech paid a sum of USD 400 million upfront payments to Laminar, with further possible payments for clinical and regulatory milestones in 2024 and beyond. 

Laminar’s innovative approach eliminates the LAA by using rotational motion. The FDA has approved Laminar for the pivotal study in the United States, and enrolment is set to start in early 2024. 

‘’For the millions of people living with AFib, stroke risk is a major concern. The team at Laminar is driven by our vision to develop and deliver an innovative solution to help patients live without the fear of stroke, or the need for long-term use of blood thinners,” said Randy Lashinski, President & CEO, Laminar. “We are looking forward to advancing this vision as part of Johnson & Johnson MedTech.” 

“We are excited to welcome Laminar to Johnson & Johnson MedTech,” said Jasmina Brooks, President, Biosense Webster. “Laminar’s innovative approach will provide Biosense Webster the opportunity to expand our portfolio in this high-growth market, complement our electrophysiology and Intracardiac Echo strengths, and deepen our presence with interventional cardiologists and electrophysiologists. Fuelled by the global scale and commercial and clinical strength of Biosense Webster, we are excited to explore the possibilities ahead to reach even more patients with critical unmet need.”

As per DelveInsight, the global Heart Closure Devices market is expected to grow at a CAGR of 9.2% during the forecast period from 2023 to 2028. The demand for heart closure devices is primarily being boosted by an increase in the incidence of congenital heart defects, rising adoption of MRI procedures, growing recognition and awareness of children born with cardiac irregularities, and continuous innovation in product development among others, thereby contributing to the overall growth of the heart closure devices market during the forecast period from 2023-2028. 

BD Launched Advanced Vascular Access Ultrasound System Designed to Improve Clinical Efficiency

On November 30, 2023, the advanced vascular access ultrasound system from BD, SiteRite™ 9 was launched, which is designed specifically help improve clinician efficiency when placing peripherally inserted central catheters (PICCs), central venous catheters, IV lines and other vascular access devices.

The SiteRite™ 9 Ultrasound System is an all-in-one device that offers industry-leading catheter placement tools and technologies to support clinicians during the vascular access device insertion process. It features an updated 15.6-inch touchscreen with enhanced image quality, making it easy to use. Additionally, it consists of the CueTM Needle Tracking System, and the Sherlock 3CG+TM Tip Confirmation System, which are integrated visualization tools present in the device, which guarantee accurate catheter tip navigation and position.

SiteRite™ 9 consists of various features such as smart, connected technology, and vessel assessment tools that are capable of automatically detecting the vessel, when paired with vessel measurement tools. The device helps clinicians to make the right decisions by selecting the correct catheter.

“Our latest innovation in ultrasound technology is designed to make vascular access care delivery easier and more efficient for clinicians — whether they’ve been on the job for years or are new to the field,” said Eric Borin, worldwide president of Medication Delivery Solutions at BD. “By combining our decades of leadership in vascular access with voice-of-the-customer enhancements, we’ve developed a best-in-class solution to aid in insertion success on the first attempt and reduce the need for repeated needlesticks to deliver a better care experience for everyone involved.”

 According to DelveInsight’s “Vascular Access Device Market, report, The global vascular access device market was valued at USD 4.59 billion in 2022, growing at a CAGR of 6.64% during the forecast period from 2023 to 2028, to reach USD 6.75 billion by 2028. The demand for vascular access devices is primarily motivated by the growing prevalence of chronic diseases like cancer, kidney failure, and heart diseases that require the use of these devices. Some other factors like the rise in the number of chemotherapies, lifestyle diseases, and their rising occurrence in pediatric patients may drive the growth of the market. 

Zilia Received FDA Clearance for its Zilia OcularTM FC Retinal Camera 

On November 29, 2023, Zilia, a medical technology company focused on the development of non-invasive assessment of ocular biomarkers announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Zilia Ocular FC TM.

Zilia’s innovative retinal camera, the Zilia Ocular FC, is a ground-breaking technology set to transform the diagnosis and management of ocular diseases, marking a pivotal moment in the company’s growth.

“Receiving this first FDA clearance for our retinal camera is not just a milestone, it’s a leap forward in our quest to safeguard the vision of millions,” said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. “We’re now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions.” 

According to DelveInsight’s “Ophthalmic Devices Market” report, the global Ophthalmic Devices Market was valued at USD 55.91 billion in 2021, growing at a CAGR of 4.12% during the forecast period from 2023 to 2028 to reach USD 71.23 billion by 2028. The demand for ophthalmic devices is primarily being boosted by the rising prevalence of myopia and the growing geriatric population base which has resulted in the increased prevalence of ocular diseases of different etiologies, increasing number of ophthalmic surgeries, and technical innovation in product development which are expected to increase in the product demand thereby contributing in the growth of the ophthalmic devices market during the forecast period from 2023-2028.

First patient enrolled in Penumbra study of computer-assisted vacuum thrombectomy

On November 28, 2023, Penumbra announced the enrolment of the first patient in STORM-PE, a trial conducted for its Lightning Flash thrombectomy system.

The Lightning Flash System, a mechanical thrombectomy device offered by Penumbra received FDA clearance in January 2023. The system consists of novel Lightning intelligent aspiration technology with dual-clot detection algorithms.

The Lightning Flash Thrombectomy System designed by Penumbra is used to rapidly remove massive blood clots, such as pulmonary emboli (PE) and venous thrombus. This combination can distinguish between blood and clots. Its design may reduce the chance of bleeding issues since it helps prevent blood loss and the requirement for medications that dissolve clots.

The company is planning to enroll 100 participants from 20 different sites.

“Our commitment to clinical research and innovation enables us to lead with insight and continue to pioneer interventional therapies that have a significant impact on patients such as our CAVT technologies,” said Dr. James F. Benenati, chief medical officer at Penumbra. “In partnership with PERT Consortium, we are committed to generating robust clinical evidence that will help transform care so patients, especially those with serious conditions such as PE, can return home quickly and live fully.”

According to DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market” report the global Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market was valued at USD 722.78 million in 2022, growing at a CAGR of 6.15% during the forecast period from 2023 to 2028 to reach USD 1033.33 million by 2028. The rise in demand for Neurovascular Thrombectomy Devices is predominantly imputed to the rising prevalence of neurovascular disorders across the globe that require Neurovascular Thrombectomy Devices for their treatment such as ischemic stroke and hemorrhagic stroke, the growing burden of the old age population. In addition, the shifting key player’s focus toward the development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors among others that are likely to upsurge the market for Neurovascular Thrombectomy Devices.

US FDA Granted the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

On November 29, 2023, BiVACOR, Inc. a medical device company engaged in the development of Total Artificial Heart announced that the United States Food and Drug Administration (FDA) granted its approval to commence an investigational device exemption (IDE) for the first-in-human Early Feasibility Study (EFS) on The BiVACOR Total Artificial Heart (BTAH).

The BiVACOR Total Artificial Heart is intended to be the first long-term treatment specifically for individuals suffering from severe biventricular heart failure. It is an implantable total artificial heart based on rotary blood pump technology. Additionally, the device uses magnetic levitation technology and is similar to the size of an adult fist. It is specially designed small when implanted in women and children and is capable of providing similar cardiac output. The device is capable of producing pulsatile outflow even in the absence of valves or flexing ventricle chambers. The non-contact suspension present in the Total Artificial Heart helps in providing large blood gaps, which minimizes the risk of mechanical wear and offers a reliable biocompatible heart replacement solution.

“I am eager to begin the BiVACOR Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” said Joseph Rogers, MD, National P.I. and CEO of the Texas Heart Institute. “The implantation of a TAH system is a potential treatment option for patients with heart failure who need support while on the heart transplant waiting list and for those who do not qualify for a transplant. The BTAH is designed to replace the function of the native heart completely. It is an impressive technology, and I am excited to see the potential of BTAH in treating patients with severe heart failure.” 

“The FDA approval to begin The BiVACOR Total Artificial Heart EFS is a critical milestone for BiVACOR and is another validation of the remarkable work and accomplishments of the entire BiVACOR team. This Device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, MD, Heart Surgeon at the Texas Heart Institute and BiVACOR Chief Medical Officer.

“We believe this study will build upon the already successful pre-clinical data we have and is expected to set up 2024 as a significant year of milestones for BiVACOR as we continue to build our database of evidence. I am incredibly proud of the unwavering hard work and dedication from our team and network around the globe for achieving this pivotal landmark in the clinical development of our TAH system,” said Daniel Timms, Ph.D., Founder and CTO of BiVACOR.

According to DelveInsight’s “Total Artificial Heart Market” report, the Total Artificial Heart market is growing at a CAGR of 13.1% during the forecast period from 2023 to 2028. The demand for Total Artificial Heart is primarily being boosted by the rising prevalence of cardiovascular disorders such as heart failure and stroke. Additionally, the shortage of heart donors across the globe, and the rising geriatric population are some of the key factors that are contributing to the growth of the Total Artificial Heart market during the forecast period from 2023-2028.