Penumbra launched the Indigo® System with Lightning™ 7 and Lightning 12 Intelligent Aspiration in Europe

On April 14, 2022, Penumbra, Inc., a leading medical device company focused on developing innovative therapies for neuro and vascular conditions, received the CE mark for its Indigo Aspiration System with Lightning 7 and Lightning 12 and also made it commercially available in Europe. 

The Indigo System with Lightning is an intelligent aspiration system powered by Penumbra ENGINE and comprises a dual pressure sensor for real-time blood flow monitoring, which is an advanced and unique computer-aided clot detecting technology that can differentiate between a clot and blood. The system is designed to minimize the risk of bleeding complications by reducing blood loss and the need for clot-dissolving drugs. CAT7 is a high-power, low-profile catheter that features laser-cut hypotube technology and circumferential sweep designed for dependable delivery and maximal clot extraction. CAT12 is a large-lumen aspiration catheter that also incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body. 

James Benenati, MD, FSIR, chief medical officer at Penumbra, Inc said, “The launch of our Lightning portfolio in Europe will provide a much-needed option for physicians to address debilitating blood clots in the body effectively and efficiently. We’ve seen our latest advancements in mechanical thrombectomy reduce blood loss while increasing clot removal efficiency in the U.S. These innovations may help improve patient care compared to conventional therapy. We are now able to help more patients with this technology by expanding access to physicians in Europe.”

“Blood clots in the body can be difficult to access and are potentially life-threatening. Until now, treatment options have been limited. The introduction of our Lightning portfolio in Europe will expand access to our most advanced clot removal technology for the body, which combines intelligent aspiration and innovative catheter engineering to remove blood clots in a single session. With Lightning, mechanical aspiration technology continues to advance to meet the needs of patients, which is our core purpose at Penumbra.” commented Joan Kristensen, vice president and head of Europe, Middle East, and Africa region for Penumbra, Inc.

According to DelveInsight’s “Neurovascular Thrombectomy Devices Market” report, the global neurovascular thrombectomy devices/neuro thrombectomy devices market is projected to grow at a CAGR of 6.11% during the forecast period from 2022 to 2027. According to the DelveInsight analyst, the rise in demand for these devices is predominantly imputed to the rising prevalence of neurovascular disorders across the globe such as ischemic stroke and hemorrhagic stroke, the growing burden of old age population. In addition, shifting key players’ focus towards 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/Neurothrombectomy Devices.

SonoScape Granted FDA 510 (k) Approval for the HD-550 Endoscopy System

On April 15, 2022, SonoScape, a company providing ultrasound and endoscopy solutions received the US FDA clearance for its flagship video endoscopy system HD-550 used for gastrointestinal diagnosis.

The system is equipped with a 4-LED source to provide 1080P high-definition images. It also enables multi-spectrum and multi-mode imaging. Further, its high-performing white-light mode, chromoendoscopy SFI (Spectral Focused Imaging), and VIST (Versatile Intelligent Staining Technology) light modes enhance vascular and mucosal color contrast which may help doctors in the detection, demarcation, and characterization of the lesions.

The system is available outside the US since 2019 and is installed in close to 40 countries.

Steven He, Sales Director of SonoScape Endoscopy said, “We have grown into a trusted name in the global endoscopy industry, we are now ready to extend our offerings to the USA healthcare providers. This FDA clearance opens up opportunities in one of the world’s biggest endoscopy markets, indeed is a powerful boost to our brand recognition, and a tremendously important phase of business development in SonoScape’s 20 years of history. “

According to DelveInsight’s “Disposable Endoscopes Market” report, the global disposable endoscopes market is expected to grow at a CAGR of 12.44% during the forecast period from 2022 to 2027. The demand for disposable endoscopes is primarily being boosted by the increasing prevalence of various disorders related to the gastrointestinal tract, respiratory tract, and others amongst the population and the onset of the COVID-19 pandemic that has raised the market for disposable endoscopes contributing to the overall growth of the disposable endoscopes market. Furthermore, as per the DelveInsight analysis, in the product segment of the disposable endoscopes market, the bronchoscopes category is expected to amass a significant share in the market revenue during the forecast period. This can be ascribed to their advantages such as the use of bronchoscopes in the diagnosis and treatment of tumors and bronchial cancers, airway blockage (obstruction), narrowed areas in the airways, and interstitial pulmonary diseases among others.

SMART Medical Systems Received FDA clearance for G-EYE® Colonoscope Series

On April 19, 2022, SMART Medical Systems Ltd., a developer of innovative endoscopy products was granted additional FDA approval for its G-EYE® Colonoscope, based on Olympus’ 510(k) cleared PCF colonoscope series. After receiving the additional FDA clearance, G-EYE® is now available for use in the US market on the commonly used colonoscope models of all three leading endoscopy brands – OLYMPUS, FUJIFILM, and PENTAX Medical.

Remanufactured by the SMART Medical, the G-EYE® Colonoscope include a proprietary balloon at its distal bending section. Withdrawal of the G-EYE® Colonoscope with the balloon moderately inflated during colonoscopy assists in controlling the colonoscope’s field of view and positioning.

Gadi Terliuc, Chief Executive Officer of SMART Medical, said, “The ability to offer G-EYE® on colonoscope brands and models commonly used and widely available in the United States is an important milestone for SMART Medical, patients, and endoscopists. The majority of U.S. endoscopists now have the option to utilize our cutting-edge technology, which has been shown in clinical studies to improve visualization compared with standard colonoscopy, while using their preferred brand and model of the colonoscope. We are very excited to have completed our portfolio of U.S. G-EYE® offerings and believe that the widespread availability of the technology on the commonly used colonoscope models has the potential to accelerate the adoption of G-EYE® colonoscopy as the standard of care.”

Brian Cochrane, Chief Commercial Officer of SMART’s U.S. subsidiary added, “We expect that this FDA clearance of the G-EYE® Colonoscope based on Olympus’ PCF scopes, which many Olympus users prefer over traditional adult-sized colonoscopes, will enhance our ability to capture a substantial portion of the U.S. colonoscopy market. We are committed to becoming the standard of care in colonoscopy, and this FDA clearance is an important step toward achieving this critical goal.”

According to the analysis done by DelveInsight, the colonoscopes market will surge due to the rising incidence and prevalence of colorectal cancer across the globe. For instance, as per the data published by the World Health Organization (WHO) in the year 2022, about 1.93 million cases of colon and rectum cancer were reported worldwide in the year 2020. In addition, an increase in preference for minimally invasive techniques, and technological advancement in the product arena are expected to bolster the global colonoscopes market.

Stimwave Technologies Begins FREEDOM-1 Clinical Trial for Peripheral Nerve Stimulation to Treat Chronic Knee Pain

On April 19, 2022, Stimwave Technologies, a medical device company that develops, manufactures, and markets, neuromodulation products launched the level-1 FREEDOM clinical trial series. The trial consists of multi-center, prospective, randomized trials that monitor chronic pain patients’ responses to peripheral nerve stimulation (PNS) over time.  

The FREEDOM-1 is the company’s first clinical trial (in the series) to evaluate treating patients with chronic knee pain using the Stimwave Freedom PNS system.

The primary endpoint of the study comprises a reduction in pain equal to or greater than 50% based on the visual analog scale and the secondary outcome will be associated with changes in the physical function of patients’ knees while undergoing treatment, and overall quality of life improvement.

Standiford Helm, MD, Lead Investigator for Freedom commented, “Knee pain is one of the most prevalent forms of chronic pain experienced by patients globally and is strongly correlated with the high volumes of surgical procedures performed each year on the joint. Despite the surgical interventions available today to fix functional problems, a patient’s quality of life can be severely impacted by chronic pain and subsequent reductions in mobility. The Freedom PNS system offers a unique solution by addressing chronic knee pain associated with a specific peripheral nerve, at the source.”

Aure Bruneau, Stimwave’s Chief Executive Officer said, “A key component of Stimwave’s long-term value creation strategy is to collaborate with leading centers to generate high-quality, level-1 clinical data that supports the appropriate use of the Freedom PNS therapy through our market-leading medical education and market access initiatives. We are very excited to launch this initial FREEDOM-1 study in connection with the treatment of chronic knee pain and look forward to launching additional similarly structured chronic pain trials as part of our larger commitment.”

According to DelveInsight’s “Peripheral Nerve Stimulators Market” report, the global peripheral nerve stimulators market growing at a CAGR of 6.9% during the forecast period from 2022 to 2027. The increase in demand for peripheral nerve stimulators is primarily attributed to the increase in number of patients suffering from nerve injuries, effective technologies in PNS,  growing awareness of peripheral nerve stimulators among people, chronic pain management therapies, increased prevalence of disease which can drive pain, increasing geriatric population, rising of obese population, growing public awareness about PNS, are anticipated to bolster the market growth, thereby contributing to the growth of the peripheral nerve stimulators market during the forecast period from 2022-2027. Moreover, as per the DelveInsight analysis, among all the regions, North America is expected to account for the largest share in the global peripheral nerve stimulators market. Factors such as the growing prevalence of chronic pains, approval of PNS, awareness of device, and increased number of geriatric population would boost the regional market growth.

Virtual Incision Received Approval to Complete Clinical Study Enrolment for its MIRA® Platform

On April 19, 2022, Virtual Incision, a company developing the first-of-its-kind miniature, and highly accessible robotic-assisted surgery (RAS) platform received the Investigational Device Exemption (IDE) supplement from the US FDA to complete the final stage of its clinical study analyzing the MIRA® Platform in bowel resection procedures.

The IDE supplement approval received by the company puts it on track to obtaining the clinical evidence required to bring innovation to the soft tissue surgical robotics industry, a market that has been dominated by a single player for the past few years. The results obtained after the completion of the study will support MIRA’s upcoming FDA De Novo application for market authorization.

MIRA Platform: it is the world’s first miniaturized robotic-assisted surgery (RAS) platform. The device is small with a sleek design and weighs only two pounds. The system with its drape- and dock-free design and portability is quick to set up, clean up, and move in between cases. It offers the benefits of RAS during abdominal procedures without the logistical inefficiencies of traditional mainframe robotics.

John Murphy, president, and chief executive officer of Virtual Incision, said, “MIRA was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturized and simplified MIRA to make it more accessible, easy to use, and easy to adopt. These are the features that will allow surgeons to treat more patients each day. It is encouraging to see MIRA demonstrating the potential to help surgeons perform simplified robotic procedures safely and precisely. Completing the final stage of our clinical study will be a key milestone along MIRA’s regulatory pathway, and we will continue to focus on clinical excellence to best support the innovation we provide to patients and surgeons.”

“Our clinical experience has been extremely positive so far. I was able to perform 100% of the dissection with MIRA in all of my cases. We have also been pleased with its accessibility and efficiency. I operated on eight patients in five different operating rooms, and that’s something that’s just not possible with mainframe RAS platforms. MIRA has the potential to bring the benefits of minimally invasive surgery to more patients, and that’s truly exciting,” commented Dr. Jobst, the first surgeon in the world to operate with the device.

According to DelveInsight’s “Surgical Robotic Systems Market” report, the global surgical robotic systems market is expected to grow at a CAGR of 11.5% during the forecast period from 2022 to 2027. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the surgical robotic systems market during the forecast period from 2022-2027. Additionally, as per the analysis done by DelveInsight, the neurosurgery application category may account for a remarkable CAGR growth in the surgical robotic systems market during the forecast period. This can be ascribed to the growing need for surgical intervention in neurosurgery. The rising prevalence of brain and spinal cord tumors is one of the key reasons behind the growing popularity of robotic systems in neurosurgery.

Axonics® Launched the Axonics F15™ Recharge-free Sacral Neuromodulation System

On April 19, 2022, Axonics, Inc., a leading medical device company primarily focused on developing and commercializing novel products for the treatment of bladder and bowel dysfunction launched its newly developed, long-lived, fully recharge-free sacral neuromodulation (SNM) system, Axonics F15, across the US. The system received FDA approval in March of this year.

Axonics F 15 has a primary cell battery. The functional life of the device has been validated for over 15 years at typical stimulation parameters and over 20 years at lower energy settings. Additionally, the device gives a constant current that automatically adjusts stimulation output and is MRI compatible. Other specifications of the device include an intuitive, recharge-free key fob featuring SmartMRI™ technology, and universal tined lead compatible with both recharge-free and rechargeable Axonics systems, among others.

Raymond W. Cohen, CEO of Axonics said, “Physician response to the Axonics F15 has been overwhelmingly positive. Our sales team is now armed with a complete portfolio of SNM products that, along with our national DTC campaign, will contribute to Axonics achieving its mission of treating more adults suffering from incontinence. We remain confident that our commitment to innovation, quality, and providing physicians and patients strong support will continue to drive SNM market expansion and advance Axonics on its path to market leadership.”According to the analysis done by DelveInsight, the Sacral Nerve Stimulation market will propel owing to the rising prevalence of overactive bladder conditions and the increasing incidence of urge incontinence, such as urinary tract infection (UTI). For instance, according to the National Association for Continence, over 25 million adult Americans experience temporary or chronic urinary incontinence in the year 2018. Moreover, the launch of technologically advanced products, the rise in strategic business activities by the players actively developing sacral nerve stimulators, and others are anticipated to bolster the global sacral nerve stimulator market in the upcoming years.