DePuy Synthes Received FDA Approval for TELIGEN™ System
On October 20, 2022, DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopedics portfolios in the world that helps heal and restore movement for the millions of patients, announced that it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for TELIGEN™ System. The system is an integrated technology platform that enables minimally invasive surgical transforaminal lumbar interbody fusion (MIS-TLIF) procedures through digital tools for visualization and access.
The TELIGEN™ System is comprised of a tower that delivers a suite of technologies, including a camera control system, a VueLIF-T™ Procedure Kit with a disposable HD camera, a TELIGEN™ Clear Discectomy Device and patient-based disposable ports. The TELIGEN™ System integrates with the UNLEASH™ bundle of implant solutions, which is designed to streamline the main stages in MIS-TLIF.
The TELIGEN System provides advanced visualization and user-centric procedural control. The patient-specific port’s digitally enabled TELIGEN VUETM camera eliminates the need for a microscope and can provide an unobstructed view of the surgical site. During the procedure, it provides hands-free visualization as well as a multidirectional and expanded field of view. Furthermore, the self-cleaning camera includes LED lighting and allows surgeons to adjust image clarity to their liking. Furthermore, the TELIGEN System heads-up display enables surgeons to maintain ergonomic posture throughout procedures. This may help to avoid severe musculoskeletal pain, which is commonly reported by spine surgeons, particularly low back and neck pain.
The TELIGE System reduces fluoroscopy time by 47% (p=0.003) compared to minimally invasive surgical transforaminal lumbar interbody fusion (MIS-TLIF) procedures performed using a surgical microscope.16 Also, the TELIGEN™ System reduces instrument trays and processing costs per surgery for the 10 additional trays not required with the TELIGEN™ System.
Dr. Michael Wang, Professor of Neurosurgery and Rehab Medicine at the University of Miami Medical Center, said, “The DePuy Synthes TELIGEN™ System with VueLIF-T procedure has the potential to change MIS spinal surgery as we know it,.” Dr. further added, “With the TELIGEN™ System, we will have a larger and clearer field of view – something we’ve never had before. This expanded visibility will be invaluable to improving surgical performance and ultimately delivering better patient outcomes.”
“Improving the MIS spinal surgery experience for both patients and surgeons is a critical step to addressing unmet needs in the industry,” said Russell Powers, Worldwide President, Spine, DePuy Synthes. He further said, “With our groundbreaking TELIGEN™ Technology Platform, we’re providing a better field of view to help improve patient care and increase efficiencies. I’m incredibly proud of this advancement from our DePuy Synthes team and how the VueLIF-T will change MIS spinal procedures.”
As per DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market” report, the global minimally invasive surgical (MIS) devices market was valued at USD 28,873.25 million in 2021, growing at a CAGR of 7.38% during the forecast period from 2022 to 2027 to reach USD 42,499 million by 2027. The demand for minimally invasive surgical (MIS) devices is expected to grow owing to an increase in the prevalence of chronic disorders such as cardiovascular diseases, neurological diseases, various cancers such as lung cancer, and others. Further, the escalating burden of the geriatric population’s presence of technologically advanced products in the market, among others, will thereby contribute to the growth of the minimally invasive surgical (MIS) devices market during the forecast period from 2022-2027.
GE Healthcare and Accuray Collaborate to Expand Access, Advance the Practice of Precision Radiation Therapy
On October 21, 2022, GE Healthcare, a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator and Accuray Incorporated, committed to expanding the powerful potential of radiation therapy to improve as many lives as possible, announced that they have signed a global commercial collaboration agreement designed to provide solutions that make it possible for more healthcare teams around the world to tailor patients’ care at every stage of their treatment journey.
The two companies will make available a comprehensive offering that brings together GE Healthcare’s precision diagnostic tools and Accuray Incorporated’s innovative radiation therapy delivery capabilities to advance the practice of radiation therapy and help deliver personalized care to patients diagnosed with cancer.
High-quality imaging is required to determine the size, shape, and characteristics of tumors, as well as sophisticated delivery technology to help precisely target tumors while differentiating and minimizing dose to healthy tissue. As advanced imaging continues to allow for earlier diagnosis and identification of smaller lesions, the need for precision and accuracy in treatment will become equally important, allowing clinicians to confidently diagnose and treat earlier-stage cancers. The collaboration aims to improve cancer diagnosis and treatment by combining GE Healthcare’s imaging solutions and Accuray radiation therapy technologies.
Initially, the collaboration will focus on addressing challenges in treating lung and brain cancers, focusing on early detection, and functional diagnostics to better inform planning decisions and targeted precise treatment delivery. Furthermore, as healthcare systems seek to build cancer care pathway solutions and streamline workflows in radiation oncology, GE Healthcare and Accuray Incorporated will seek to drive digitalization and interoperability.
Jan Makela, President & CEO of Imaging for GE Healthcare, said, “Personalized medicine demands precision in both diagnosis and delivery,” He also said, “As we continue to build out our oncology offerings to help enable more precise, connected and compassionate care, we are committed to helping cancer care providers gain the upper hand through our suite of diagnostic technologies that help improve detection, as well as clinical and operational efficiency. In the face of complex diagnoses, we work to make the first image count in order to help shorten the window from diagnosis to treatment. We’re excited about the opportunity to work with Accuray and expand access to our advanced imaging tools as we aim to provide a pathway to earlier diagnosis and better treatment options.”
“The radiation therapy community is redefining personalized medicine with advances in technology that improve the cancer care continuum, from diagnosis to survivorship. For Accuray, this involves a continuous focus on innovation of our treatment planning and delivery technologies to help ensure medical care teams can deliver the most precise radiation treatments possible in the shortest amount of time,” said Suzanne Winter, President & CEO of Accuray. He further commented, “In 2022 it is estimated that more than one million U.S. cancer patients will receive treatment with radiation therapy. This statistic underscores the importance of our collaboration with GE Healthcare, a global leader in healthcare committed to creating best-in-class oncology solutions, to elevate the visibility of our solutions and ultimately, make potentially life-saving radiation therapy treatments available to more people.”
According to DelveInsight’s “Radiotherapy/Radiation Oncology Devices Market” report, the global radiotherapy/radiation oncology devices market is expected to grow at a CAGR of 7.78% during the forecast period from 2022 to 2027. The radiotherapy/radiation oncology devices market is estimated to register positive revenue growth owing to factors such as the rising prevalence of cancers. Furthermore, rapid technological activities, strong research & developmental activities by the key players, rising adoption of radiotherapy procedures in cancer treatment, growing demand for minimally invasive procedures, and others are anticipated to bolster the market, thereby contributing to the growth of the radiotherapy/radiation oncology devices market during the forecast period from 2022-2027.
MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval
On October 24, 2022, Med Alliance SA, a privately-owned medical technology company, announced that SELUTION SLR™, the company’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial. SELUTION SLR is the first sustained limus-release coronary drug-eluting balloon (DEB) to receive FDA IDE approval for In-stent Restenosis (ISR) indication. The study has already begun enrollment in Europe.
SELUTION SLR is commercially available in Europe, Asia, the Middle East and the Americas (outside the USA), and most other countries where the CE Mark is recognized. Over 10,000 units have already been used for patient treatment in routine clinical practice or as part of clinical trials. More than 540 patients of the 3,326 planned have already been enrolled in this ground-breaking coronary randomized controlled study comparing SELUTION SLR vs. any limus drug-eluting stent (DES).
The study is powered to demonstrate the superiority of SELUTION SLR DEB over DES for coronary de novo artery disease. Enrolment of the IDE SELUTION4ISR FDA coronary study is already ongoing in Europe and will start in the US later this year. The trial will be conducted at up to 60 centers worldwide and in up to 40 centers in the US. This study is powered to demonstrate non-inferiority vs. standard of care (80% against DES and 20% against POBA), and is currently 10% enrolled, with ClinicalTrials.gov Identifier: NCT04280029.
“We are pleased with the speed of European enrolment and look forward to enrolling the first US patient before the year-end; US site selections are underway and will be finalized over the next several weeks. This study has the potential to address the important unmet need of a non-stent treatment for the ongoing problem of in-stent restenosis”, commented Dr. Don Cutlip, Principal Investigator of the IDE SELUTION4ISR Study and the Chief Medical Officer at Baim Institute for Clinical Research.
Jeffrey B. Jump, MedAlliance Chairman, and CEO added, “This is another significant milestone for MedAlliance: we were the first sustained limus release balloon to receive FDA IDE approval, the first to begin enrollment and now the first to have three applications approved. This is the culmination of a multi-year R&D program that delivered comprehensive pre-clinical data meeting the very high standards of the US FDA.”
He further stated, “We are very pleased with the high level of market acceptance we are experiencing in Europe, Asia and South America, and we look forward to entering the US market following the successful culmination of this important clinical study and receipt of FDA approval. We are currently enrolling our US Below-the-knee (BTK) study: enrollment is ahead of schedule. We have had significant success with enrollment of the larger randomized sister study, the international coronary SELUTION DeNovo study, and are excited to offer this new treatment option to US patients, avoiding permanent metal implants. No drug coated balloon is currently approved in the US for coronary indications.”
According to DelveInsight’s “Drug-Eluting Stents Market” report, the global drug-eluting stents market was valued at USD 2.57 billion in 2021, growing at a CAGR of 8.09% during the forecast period from 2022 to 2027, it is expected to reach USD 4.08 billion by 2027. The increase in demand for drug-eluting stents is predominantly attributed to the growing prevalence of the geriatric population, as the elderly are more prone to cardiovascular disorders. Further, the increasing prevalence of hypertension, diabetes, obesity, arteriosclerosis, and others are anticipated to spur the demand for the device in the market. Additionally, the growing focus on developing a newer generation of drug-eluting stents to minimize post-procedural complications is further expected to drive the demand for drug-eluting stents in the forthcoming years, which is thereby anticipated to drive the global drug-eluting stents market during the forecast period 0f 2022 – 2027.
EndoStim Received FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory Gastroesophageal Reflux Disease
On October 25, 2022, EndoStim, a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug-refractory gastroesophageal reflux disease (GERD), declared that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
The FDA Breakthrough Device Designation program is intended to provide patients and health care providers with timely access to medical devices for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by expediting their development, assessment, and review while maintaining the statutory standards for premarket approval or clearances.
The EndoStim System comprises an implantable neurostimulation device and a lead that is placed through a quick, minimally invasive laparoscopic procedure. The system is intended to provide long-term reflux control by automatically delivering mild electrical signals to the patient’s weak or dysfunctional lower esophageal sphincter (LES) muscle throughout the day (the underlying cause of GERD). The EndoStim system, which is wirelessly programmed by a physician using an external handheld controller, automatically stimulates the LES to allow it to function normally without causing any discomfort to the patient.
“We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. Eric Goorna also added, “Our goal is to bring this new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the review of the EndoStim System.”
According to DelveInsight’s “Neurostimulation Devices Market” report, the global neurostimulation devices market was valued at USD 5.82 billion in 2021, growing at a CAGR of 11.77% during the forecast period from 2022 to 2027, to reach USD 11.34 billion by 2027. The increase in demand for neurostimulation devices is predominantly attributed to the spike in the population suffering from neurological disorders such as epilepsy and migraine, escalating product demand as add-on therapy, and the shifting focus towards developing technologically advanced products, which is thereby anticipated to drive the global neurostimulation devices market during the forthcoming years.
Mentice and Acandis GmbH Announced a Three-Year Agreement for Mentice Ankyras Clinical Support Software Solutions
On October 25, 2022, Mentice AB, a world leader in simulation solutions for image-guided interventional therapies, announced that Acandis, a leading innovator of minimally invasive devices for the treatment of neurovascular diseases, has signed a 3-year collaboration agreement to further develop the Acandis clinical support platform and supply their customers with Mentice Ankyras clinical support software solutions, for an order value of 8.9mSEK.
Dr. Schüssler, CEO of Acandis, stated, “For us, the clinical use of our devices in combination with the Ankyras software solution has been a great success and we are glad to be able to continue with this new agreement. We believe that a strong partnership between Acandis and Mentice can substantially contribute to the future of neurovascular interventions with benefits for both physicians and patients in terms of an optimal treatment outcome.”
“We are excited about the ability to extend the relationship with Acandis for another three years. Acandis has achieved fantastic results using Ankyras simulation connected with the roll-out of their devices, and we are thrilled to be able to work together to continue to enhance the safety and outcome for patients. This agreement is a testament to the continued trust between the companies and embraces the relevance of the Ankyras cloud-based solutions supporting physicians and treatment protocols for cerebral aneurysm treatment protocols.” commented Göran Malmberg, CEO of Mentice.
According to DelveInsight’s “Clinical Decision Support Systems Market” report, the global clinical decision support systems market was valued at USD 2.23 billion in 2021, growing at a CAGR of 6.62% during the forecast period from 2022 to 2027 to reach USD 3.38 billion by 2027. The rise in demand for clinical decision support systems is predominantly attributed due to the increasing prevalence of various chronic diseases owing to the unhealthy lifestyle. Also, the growing demand for intelligent software solutions in the healthcare sector and the increasing product development activities with respect to clinical decision support systems, among others, will aid in increasing its demand in the market. As per the Delveinsight analysis, North America is expected to have the fastest growth in revenue in the overall clinical decision support systems market during the forecast period. This is due to the factors such as the increasing prevalence of lifestyle or chronic disorders like diabetes, and hypertension, the growing geriatric population, and others are expected to aid in the growth of the North American clinical decision support systems market.
Indigo Diabetes Enrolled First Participant in the Shine Clinical Trial
On October 25, 2022, Enspectra Health, a digital health company pioneering the field of virtual biopsies, stated that the first subject had been enrolled in its VISTA US Pivotal Study.
VIO™ Imaging for Skin Tissue Assessment (VISTA) is a prospective, multicenter study designed to demonstrate the safety and effectiveness of the VIO System in subjects planning to undergo routine skin biopsy.
The VIO System will be used to obtain non-invasive in vivo images of tissue features such as epidermis, dermis, collagen, blood vessels, and pigment in up to 65 subjects for the study. Following the biopsy, images obtained with the VIO System will be compared to images obtained from the skin biopsy. The study will also assess clinicians’ ability to correctly identify tissue features on VIO System images.
A leading network of comprehensive dermatology services, Golden State Dermatology will serve as the valued clinical study partner for Enspectra Health for the VISTA Pivotal Study. Subjects will be enrolled at three Golden State Dermatology locations around the greater San Francisco Bay Area.
“The VIO System has the potential to become a groundbreaking tool for pathological evaluation of the skin, by allowing visualization of skin cells and structures in real time,” said Dr. Michael Wang, Dermatologist and Dermatopathologist with Golden State Dermatology.
Gabriel Sanchez, CEO of Enspectra Health, said, “The initiation of patient enrollment in the VISTA Study reinforces our commitment to a non-invasive approach to pathology,” He further added, “Evaluating the VIO System’s ability to obtain digital color images of cellular structure in live skin non-invasively and in real time is the first step in transforming patient care.”
According to DelveInsight’s “Biopsy Devices Market” report, the global biopsy devices market is expected to grow at a CAGR of 5.1% during the forecast period from 2022 to 2027. Factors such as the increasing prevalence of breast cancer, rise in the geriatric population, growing incidence of lung cancer, rising technological advancements, and others are expected to drive the overall biopsy devices market during the forecast period of 2022-2027. Further, as per the Delveinsight analysis, in the product type segment of biopsy devices, needles are expected to hold a significant share in the year 2021. This is primarily owing to the advantages offered by the segment. The needles offer one of the less invasive approaches than open and closed surgical biopsies. Moreover, the needle’s segment is less painful, offers greater sampling accuracy, is less expensive, and patients can easily resume their regular activities after recovery. Thus, the aforesaid factors will propel the demand for the needles category in the upcoming years.