Olympus Launches New Gynecologic Power Morcellator for Its Contained Tissue Extraction System
On November 30, 2022, Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, launched the moresolution™ Power Morcellator, manufactured by TROKAMED GmbH and available in the U.S. through a distribution agreement with Olympus America, Inc.
The moresolution™ Morcellator is designed for advanced gynecologic procedures with large, calcified tissue specimens. The Olympus Contained Tissue Extraction System includes the PneumoLiner™, a first-of-its-kind containment device, and the moresolution™ Morcellator, which together offer patients a laparoscopic surgical option for tissue removal as an alternative to open hysterectomy or open myomectomy.
Features of the moresolution™ Morcellator include:
- Capability to cut thick or calcified fibroids
- Effective cutting may help save time in the operating room
- Lightweight hand-piece intended to reduce surgeon fatigue
- Safety features include the option to keep the device in ‘Cut’ or ‘No Cut’ mode
- Autoclavable and reusable components may support efforts for cost reduction
“We are excited to offer a new power morcellation solution for minimally invasive gynecological procedures,” said Richard Reynolds, President of the Medical System Group at Olympus America, Inc. He further added, “Olympus supports the safe use of power morcellators with a contained extraction system according to FDA guidance. This device reflects a response to our customers’ requests for more power and control during the procedure. This particular device works very well on very dense, calcified tissue, which is difficult to cut with other devices.”
As per DelveInsight’s “Morcellators Market” reports, the global morcellators market was valued at USD XX in 2021, growing at a CAGR of 6.4% during the forecast period from 2022 to 2027 to reach USD XX by 2027. The demand for morcellators is expected to grow owing to the increasing prevalence of uterine fibroids among women globally. Further, the rise in the preference for minimally invasive gynaecological procedures, the rising number of hysterectomy and laparoscopy procedures, favourable health reimbursement as well as technological advancements in morcellators, among others, will thereby contribute to the growth of the morcellators market during the forecast period from 2022-2027.
Journey Biosciences Launched NaviDKD™ for People with Diabetes to Predict Long-Term Kidney Complications
On December 1, 2022, Journey Biosciences, Inc., a biotechnology company offering biomarker-based predictive risk screening technologies for diabetes-related complications, announced the launch of its product NaviDKD.
NaviDKD, is a blood test based on biomarkers, to assess the risk of kidney disease in diabetics, years before the actual onset of clinical signs or symptoms. NaviDKD, in conjunction with its proprietary Compass reporting platform, offers actionable insights for preventing and managing kidney complications before they occur.
“For the one-in-three people with diabetes who will develop diabetic kidney disease, NaviDKD provides an opportunity to fundamentally change their ultimate health outcomes,” said Adam Graybill, Chief Executive Officer of Journey Biosciences. He added, “By identifying those at elevated or high risk of developing DKD before any symptoms or clinical indications, the conversation between doctor and patient can focus on taking proactive, preventative action instead of reacting to an unwanted diagnosis.”
According to DelveInsight’s “Insulin Infusion Pumps Market” report, the global insulin infusion pumps market was valued at USD 6.48 billion in 2021, growing at a CAGR of 8.69% during the forecast period from 2022 to 2027, to reach USD 10.68 billion by 2027. The insulin infusion pumps market is estimated to register positive growth, primarily owing to the rising prevalence of diabetes mellitus. Further, the rising sedentary lifestyle among people, the increasing geriatric population base prone to diabetes, and the growing focus on improving product safety and usability of insulin infusion pumps, among others, are anticipated to bolster the market, thereby contributing to the growth of the insulin infusion pumps market during the forecast period from 2022-2027. According to Delveinsight analysis, North America is expected to have the fastest growth in revenue in the overall insulin infusion pumps market during the forecast period. This is due to factors such as the increasing prevalence of diabetes in the region, the growing geriatric population, rising product approvals and launches, the presence of a favorable reimbursement system, and others, thus aiding in the growth of the North American insulin infusion pumps market.
GE Approved Separation of GE Healthcare
On November 30, 2022, General Electric Company, an American multinational conglomerate headquartered in Boston and founded in 1892, announced that its Board of Directors had approved the previously announced spin-off of its healthcare business, GE Healthcare Holding LLC.
Also, preceding such a spin-off, GE HealthCare is expected to be converted into a corporation and renamed as GE HealthCare Technologies Inc. The company is expected to begin trading on January 4, 2023, under the ticker “GEHC”.
GE’s Board of Directors approved distribution to GE shareholders of at least 80.1% of the outstanding shares of GE HealthCare. The owners of GE common stock will be entitled to receive one share of GE HealthCare common stock for every three shares of GE common stock held on December 16, 2022, the record date for distribution. Further, the distribution is predicted to happen after the US market closes on January 3, 2023.
For US federal income tax purposes, the distribution will be conducted in a tax-efficient manner for GE shareholders in the United States. The distribution is subject to certain conditions described in the registration statement on Form 10 filed by GE HealthCare.
Most importantly, upon the spin-off, GE will retain up to 19.9% of the outstanding shares of GE HealthCare’s common stock.
GE Chairman and CEO, GE Aerospace CEO, H. Lawrence Culp, Jr. said, “Today’s announcement marks one of the final milestones for our planned spin-off of GE HealthCare as we move toward launching three independent, industry-leading, and investment-grade companies. GE HealthCare is driving precision care globally, with a clear strategy for value creation that will benefit patients, customers, and shareholders under the leadership of CEO Peter Arduini and his team.”
According to DelveInsight’s “Molecular Diagnostics Market” report, the global molecular diagnostics market was valued at USD 16.49 billion in 2021, growing at a CAGR of 9.16% during the forecast period from 2022 to 2027, to reach USD 28.44 billion by 2027. The molecular diagnostics market is estimated to register positive revenue growth owing to factors such as the rising incidence of infectious diseases such as COVID-19, HIV, Herpes, and others. Further, the rising prevalence of cancers, rapid technological advancements in molecular diagnostic products, increasing demand for point-of-care diagnostics along with rising consumer awareness regarding quick diagnosis, among others, are anticipated to bolster the market, thereby contributing to the growth of the molecular diagnostics market during the forecast period from 2022-2027. According to the Delveinsight analysis, North America is expected to have the fastest growth in revenue in the overall molecular diagnostics market during the forecast period. This is due to factors such as the increasing burden of infectious diseases, the rising number of cancer patients, the growing geriatric population in the region, rising product approvals and launches, the presence of a favorable reimbursement system, the presence of key market players, and the growing demand for point-of-care diagnosis are expected to aid in the growth of North America molecular diagnostics market.
Enovis Received FDA Approval for STAR® Ankle
On December 1, 2022, Enovis Corporation, an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows, announced the U.S. Food and Drug Administration (FDA) approval for its STAR Patient-Specific Instrumentation (STAR PSI System) for use with the Company’s STAR® total ankle replacement system.
Each patient receives a personalized pre-operative plan from the STAR PSI System. To plan for the total ankle replacement case, surgeons receive and review a 3D visualization of the patient’s ankle joint, including information about any existing implants and bone defects. The STAR PSI System is used in conjunction with an updated and simplified surgical technique, which has the potential to shorten the operative time in total ankle replacement cases.
Gary Justak, President of Enovis Foot & Ankle said, “We acquired the STAR Ankle just two years ago, and the FDA approval of STAR PSI is just one example of our team’s commitment and investment to taking this best-in-class product to the level it deserves. Surgeons now have leading pre-operative planning and cutting guides, that when paired with years of proven, clinical data, set STAR® Ankle up for a brilliant future.”
Dr. Gregory Lundeeni, a foot and ankle orthopaedic surgeon based in Reno, Nevada, said, “I’m excited about the Enovis addition of PSI technology which will have great benefit to STAR patients by providing personalized cutting guides and accurate implant sizing to match their unique anatomy. Surgeons will be able to take advantage of the improved precision and efficiency of STAR’s patient-specific cut guides.”
According to DelveInsight’s “Total Ankle Replacement Prosthesis Market” report, the global total ankle replacement prosthesis market is expected to grow at a CAGR of 6.00% during the forecast period from 2022 to 2027. The increase in demand for total ankle replacement prostheses is predominantly attributed to the growing burden of the geriatric population across the globe, as the elderly are more prone to orthopedic disorders. Further, the increasing prevalence of osteoarthritis and rheumatoid arthritis are also anticipated to spur the market demand for total ankle replacement prosthetic devices. Additionally, the rising focus of companies on developing advanced technology, the rising product approvals and others are anticipated to drive the global total ankle replacement prosthesis market during the forecast period from 2022 to 2027.
Deep Blue Medical Advances Announced FDA Clearance of T-Line Hernia Mesh for Sublay Application in Hernia Surgery
On December 7, 2022, Deep Blue Medical Advances, addressing the unacceptable high rates of hernia recurrence and providing surgeons with a superior surgical experience, received the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line® Hernia Mesh for the sublay technique in open hernia surgery.
Deep Blue’s T-Line® mesh design incorporates novel mesh extensions that provide superior anchor strength, preventing mesh fixation failure. The T-design Line allows the surgeon to provide optimal mesh tension adjustment as well as many other potential surgical and clinical advantages over traditional mesh applications. Also, for large incisional hernias, the sublay procedure is the most commonly used open-surgery ventral hernia repair method.
The T-Line Hernia Mesh is now approved for the reinforcement of soft tissue where weakness exists during the repair of ventral hernias in adults using an open onlay or sublay approach.
Dr. Howard Levinson, Deep Blue’s founder and Chief Medical Officer, said, “Many hernia surgeons prefer the sublay technique for hernia repair and have been eager to use T-Line for this, so we are thrilled to receive this clearance to enable broader clinical use.”
“There are 4–5 million abdominal incisions (laparotomies) performed annually in the United States with hernias resulting after approximately 25% of these procedures. Further, long-term ventral hernia repair failure rates are up to 32% using conventional mesh and 63% with suture repair only, creating a multibillion-dollar clinical cost to the US healthcare system. Consequently, there are over 400,000 incisional hernia repairs performed each year in the United States, making it one of the five most common procedures performed by general surgeons,” said CEO Bill Perry. Perry added, “This expanded clinical indication, allowing our growing number of clinical sites to address this important problem in significantly treating more patients with T-Line Hernia Mesh.”
According to DelveInsight’s “Hernia Repair Devices Market” report, the global hernia repair devices market was valued at USD 4 billion in 2021, growing at a CAGR of 5.08% during the forecast period from 2022 to 2027, it is anticipated to reach USD 5.38 billion by 2027. The increase in demand for hernia repair devices is predominantly attributed to the spike in the population suffering from hernias. Further, the shifting focus towards developing technologically advanced products, the rising geriatric population base prone to hernia damage, the rising number of hernia surgeries, favorable reimbursement scenarios, and other factors are anticipated to drive the global hernia repair devices market during the forthcoming years.
Medtronic Completes Enrolment in Pivotal Trial Evaluating First-Of-Its-Kind Pulsed Field Ablation Catheter for Patients with Atrial Fibrillation
On December 5, 2022, Medtronic, a leading global healthcare technology company, announced that the company had completed the enrollment and final treatment for the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial designed to evaluate the safety and effectiveness of the first-of-its-kind Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation (AF).
The investigational technology comprised the Affera mapping/navigation platform, designed to improve efficiencies by enabling intuitive HD mapping to diagnose arrhythmias and treat patients with one catheter.
The Sphere-9 catheter combines mapping, navigation, and therapeutic capabilities. Also, the device is the only catheter capable of delivering both RF and PF energies for ablation, providing physicians with the ability to customize treatment based on a patient’s needs during an ablation procedure.
Further, the SPHERE Per-AF Trial is a global, prospective, multicenter, randomized clinical trial. Since the trial’s commencement in December 2021, the trial enrolled 477 patients with persistent AF across 23 centres in the U.S. and Europe. In the trial, the patients were assessed for 12 months for safety and efficacy.
“During the trial, my observations and experience with the novel Affera system have been very promising,” said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernards Medical Center, Jonesboro, Arkansas, a participating site in the SPHERE Per-AF trial. Devi Nair added, “Unlike conventional technologies, I’ve been impressed with the ability to both maps and ablate with the option of dual energy sources, with one catheter. I look forward to the results of the trial and remain optimistically enthusiastic as I continue to understand the safety and efficacy of the Sphere 9 ablation catheter.”
Rebecca Seidel, President, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic, said, “Treating the final patient in the fast-moving SPHERE Per-AF Trial builds on the exciting phase of innovation and growth at Medtronic over the last year, including the acquisition of Affera, our agreement to distribute a differentiated portfolio of left-heart access tools and devices to support a zero-exchange procedure workflow, and the continued progress in the development of PulseSelect, our organic PFA system.” Seidel also commented, “Thanks to the innovation and expertise within Affera and the support of our Medtronic team, together we’re able to continue to evaluate new, best-in-class solutions and commercialize a full, comprehensive portfolio to help physicians treat patients around the world.”
According to DelveInsight’s “Radiofrequency Ablation Devices Market” report, the global radiofrequency ablation devices market was valued at USD 3.64 billion in 2021, growing at a CAGR of 9.37% during the forecast period from 2022 to 2027; it is expected to reach USD 6.19 billion by 2027. The rise in the demand for radiofrequency ablation devices is mainly attributed due to the increasing prevalence of various chronic diseases such as cardiovascular disorders, diabetes, and others. Further, the rising elderly population base prone to chronic diseases, rising technological advancements, and increasing applications of radiofrequency ablation devices are expected to boost the radiofrequency ablation devices. As per the Delveinsight analysis, North America is expected to have the fastest growth in revenue in the overall radiofrequency ablation devices market during the forecast period. This is due to factors such as the increasing prevalence of chronic pain from various reasons such as lower back pain, neck pain, and arthritis, surging awareness among people regarding disease management, new product launches in the region, and others that are expected to aid in the growth of North America radiofrequency ablation devices market.
NeuroOne® Successfully Completed Feasibility Study with its OneRF™ Ablation System
On December 6, 2022, NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced that the company had completed a feasibility study with its OneRF™ ablation system, a developing technology that utilizes existing implanted sEEG diagnostic electrodes for brain tissue lesioning.
The study evaluated the new RF ablation system in an animal model. The study used NeuroOne’s FDA-cleared sEEG electrodes combined with a proprietary RF generator and a unique temperature control accessory that monitors and maintains the temperature at which the ablation is performed, allowing clinicians to set the temperature and time for each ablation.
Dr. Van Gompel and his team implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of ten RF ablations using different settings for temperature and time. All ablations were confirmed by an MRI scan.
Dave Rosa, CEO of NeuroOne said, “This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to monitor and adjust settings based on temperature throughout the ablation. The addition of this feature may improve the safety of the procedure. We are extremely excited regarding the continued progress with the OneRF ablation system and believe it could have a significant impact in setting a new gold standard for these procedures, if successful. We look forward to the FDA submission of the device in the second calendar quarter of 2023.”According to DelveInsight’s “Ablation Devices Market” report, the global ablation devices market is anticipated to grow at a CAGR of 11.65% during the forecast period 2022 to 2027. Some of the key factors, such as the increasing prevalence of cardiovascular diseases (like cardiac arrhythmia, atrial fibrillation, and stroke), the surging incidence of cancers, expanding cases of chronic pains such as musculoskeletal pains, and others, are anticipated to increase the demand for ablation devices in the coming years. Further, rising technological advancements, an increasing geriatric population, and others are expected to drive the overall ablation devices market growth. Further, per the Delveinsight analysis, radiofrequency ablators are expected to hold a significant share in the by technology segment of ablation devices in the year 2021. This is primarily owing to the advantages offered by the segment. The radiofrequency ablators are minimally invasive, have excellent local tumour control, have promising long-term survival, and have a multimodal approach. Thus, the aforementioned factors will propel the demand for radiofrequency ablator’s category in the upcoming years, thereby bolstering the overall market for ablation devices.