HELIOSTAR™ Radiofrequency Balloon Ablation Catheter Launched by Biosense Webster in Europe

On October 12, 2022, Biosense Webster, a part of Johnson & Johnson Medical technology, announced the launch of HELIOSTAR™ Balloon Ablation Catheter, the first radiofrequency balloon ablation catheter in Europe. With personalized energy delivery and a single integrated 3D mapping solution, the HELIOSTAR™ Balloon Ablation Catheter’s innovative one-shot balloon technology provides pulmonary vein isolation in 12 seconds. The HELIOSTAR™ Balloon Ablation Catheter, when used with a compatible multi-channel RF generator, is indicated for cardiac ablation as well as catheter-based cardiac electrophysiological mapping (stimulating and recording) of the atria.

The 3D mapping system CARTO™ 3 System is completely integrated with the HELIOSTAR™ Balloon Ablation Catheter. The HELIOSTAR Balloon Ablation Catheter can perform single-shot pulmonary vein isolation (PVI) in 12 seconds and contains a compliant balloon that can adapt to different pulmonary vein morphology. Fluoroscopy time and exposure may be decreased by using the HELIOSTAR™ Balloon Ablation Catheter in conjunction with the LASSOSTAR Catheter and CARTO™ 3 System, which may be advantageous to both the patient and the doctor. Less time in the facility and less anesthesia and radiation may be needed for shorter procedures. These time savings might also make it possible to do more daily treatments, improving patient access. In the United States, there is no commercial supply of the HELIOSTAR™ Balloon Ablation Catheter.

The ten gold-plated, irrigated electrodes on the HELIOSTAR™ Balloon Ablation catheter allow for individualized power delivery to each electrode based on anatomical position and known tissue thickness. The only multi-electrode single-shot balloon that can perform circumferential and segmental ablation is the HELIOSTAR™, enabling customized PV ablation. The catheter can transmit titrated radiofrequency energy for a configurable workflow, and the amount of power delivered to each electrode can be individually controlled.

Prof. Gian Battista Chierchia, Full Professor in Cardiology, HRMC, Brussels, Belgium, CMO Electrophysiology Frontiers, said, “The HELIOSTAR™ catheter is an effective and efficient technology, enabling great results in less procedure time, which has many benefits to both my patients, myself and my staff. The high single-shot isolation success rate is particularly valuable when it comes to procedural efficiency, and at my institution, we’ve been able to reproducibly perform procedures in 15 – 20 minutes.”

As per DelveInsight’s “Balloon Catheters Market” report, the global balloon catheters market was valued at USD 4.60 billion in 2021, growing at a CAGR of 8.78% during the forecast period from 2022 to 2027 to reach USD 7.62 billion by 2027. The rise in the demand for balloon catheters is primarily due to the rising prevalence of lifestyle disorders such as hypertension and obesity, which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, the growing geriatric population across the globe, the increasing technological advancements in the product portfolio, among others; thereby contributing in the growth of the balloon catheters market during the forecast period from 2022-2027.

NeuroLogica Receives European Union CE Marking for all its Elite Mobile Computed Tomography Devices by Adhering to the New EU Medical Device Regulation

On October 12, 2022, NeuroLogica, a part of Samsung Electronics Co. Ltd., announced the European Union (EU) CE marking for its cutting-edge Elite Mobile Computed Tomography (CT) equipment obtained through compliance with the new EU Medical Device Regulation (MDR 2017/745). 

The OmniTom Elite, BodyTom Elite, and CereTom Elite mobile CT systems have been approved following evaluation and certification by the EU’s Notified Body. 

The previous EU MDD (Medical Device Directive 93/42/EEC) was replaced by the EU MDR (EU Medical Device Regulation 2017/745). Technical documentation, clinical data, and post-market surveillance all receive significant attention in the new requirements, thus making the regulation more updated in compliance with the prevalent health and safety standards. 

The United States Food and Drug Administration quality system rules are already followed by NeuroLogica, which is also accredited to the ISO 13485 standard. The design, manufacture, installation, servicing, and engineering of imaging systems for medical purposes are all made possible by goods and procedures that adhere to international regulatory standards.

In order to continue providing client assistance, NeuroLogica has created partners in Europe that serve as Economic Operators, possessing a strong network of experienced distributors. The company will continue to produce its mobile CT product line in Danvers, Massachusetts, in the US and export it to customers in the EU.

Jason Koshnitsky, Sr. Director of Global Sales and Marketing, NeuroLogica, said, “The achievement of this certification sheds light on our continued dedication to bringing innovative solutions to hospitals and clinics globally. It will allow a greater number of healthcare providers to have access to cutting-edge diagnostic imaging to deliver high-end patient care.”

“Compliance with EU MDR is an important regulatory milestone that exhibits NeuroLogica’s efforts towards demonstrating conformance to EU regulatory requirements, making mobile CT systems available in the European Economic Area and remaining committed to product quality and safety.” said Dr. Ninad Gujar, Vice President of Regulatory Affairs, Quality Assurance and Corporate Compliance.

According to DelveInsight’s “Computed Tomography Market” report,” the global computed tomography market was valued at USD 6.13 billion in 2021, growing at a CAGR of 6.36% during the forecast period from 2022 to 2027, in order to reach USD 8.87 billion by 2027. The computed tomography market is estimated to register positive revenue growth owing to an upsurge in the cases of severe chronic diseases such as cardiovascular, oncological and others, rapid technological advancements in product design, increased awareness of early diagnosis, coupled with the rise in geriatric population,  thereby contributing in the growth of the computed tomography (CT) devices market during the forecast period from 2022-2027.

Pfizer and BioNTech Present Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals Aged 18 Years and Older

On October 13, 2022, Pfizer and BioNTech announced early results from a Phase II/III clinical trial investigating the safety, tolerability, and immunogenicity of the firms’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. 

Based on sera collected 7 days after administration, a 30-g booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine showed a significant increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels, with similar responses seen in people between the ages of 18 and 55 and those over 55 (40 participants in each age group). A 30-g booster dose of the Original Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2 Wild Type) was given to people older than 55, who either received the bivalent vaccine or the original vaccine, resulted in more modest increases in the neutralizing antibody response against the Omicron BA.4/BA.5 variants.

These preliminary data on the bivalent vaccine further corroborate the fact that COVID-19 vaccine responses so far have consistently demonstrated consistent trends across age groups. 

In this multicentered, randomized, controlled Phase II/III trial, nearly 900 healthy volunteers  12 years of age and older received at least three doses of an approved COVID-19 vaccination. Participants in the trial got a 30-g or 60-g booster dose of the Omicron BA.4/BA.5-adapted COVID-19 vaccine developed by Pfizer and BioNTech, while those between the ages of 12 and 17 received a 30-g dose.

Study Results: 

  • Effectiveness: The findings showed that a 30-g booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccination should protect both younger and older persons against the Omicron BA.4 and BA.5 variants more effectively than the original vaccine.
  • Safety: The data indicates a positive safety profile for the Omicron BA.4 and BA.5-bivalent vaccine, which is well tolerated and similar to the safety profile of the original vaccine.

Since the earliest days of the pandemic, we have strived to transparently share data regarding our COVID-19 vaccines in the interest of public health. While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults.” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. He further added that  “These early data suggest that our bivalent vaccine is anticipated to provide better protection against currently circulating variants than the original vaccine and potentially help to curb future surges in cases this winter.”

Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said, “These preliminary findings are consistent with our preclinical data showing a substantial increase in the neutralizing antibody response against the Omicron sublineages BA.4 and BA.5. The current dominance of BA.4/BA.5 and related sublineages, underscores the importance of our data and science-based approach to develop a vaccine which is adapted to these prevalent strains of the virus and make it available in a timely manner.”

According to DelveInsight’s “Vaccines Market” report, the global vaccines market was valued at USD 104,156.90 million in 2021, growing at a CAGR of -11.47% during the forecast period from 2022 to 2027, to reach USD 65,074.86 million by 2027. The increase in the demand for vaccines is owing to various factors such as the increasing prevalence of infectious diseases, the rising demand for vaccines to curb the COVID-19 infection, extensive focus on child immunization programs, the increasing prevalence of various cancers which is thereby anticipated to drive the global vaccines market during the forthcoming years.

Philips Expands Rollout of its ClarifEye Augmented Reality Surgical Navigation Solution to Japan 

On October 13, 2022, Philips, a leading global healthcare technology, a global leader in health technology announced the expanded rollout of its augmented reality (AR) surgical navigation solution – ClarifEye – to Japan after highlighting positive results in patients treated at Mita Hospital (Tokyo, Japan) using this innovative 3D AR solution. Installed on a Philips interventional X-ray system in a hybrid operating room at Mita Hospital, ClarifEye helped surgeons to successfully perform minimally invasive image-guided procedures on patients with spinal stenosis (narrowing of spaces in the spine) and scoliosis (a sideways curvature of the spine).

ClarifEye, Philips’ augmented reality surgical navigation device, integrates 3D AR navigation with 2D and 3D graphics at low X-ray exposure. While minimizing harm to delicate neurological and circulatory systems near the patient’s spine, it enables surgeons to define and navigate crucial trajectories for precise device placement. 

In order to track patient positioning, ClarifEye’s live-video computer vision and augmented reality (AR) technology applies non-invasive position markers to the patient’s skin. The resulting live video is then superimposed on a 3D cone-beam CT scan of the patient’s spinal column. Without the use of live X-ray imaging, it allows surgeons to see both the inside and outside of the patient in the same image, along with the planned and actual route of a Philips ClarifEye needle. By doing away with the onerous reference frames that prior systems required, the technology allows surgeons unrestricted access to the patient.

Dr. Ken Ishii, Department of Orthopedic Surgery, International University of Health and Welfare, Mita Hospital, said, “The benefit of performing spine surgery in the Hybrid OR includes the ability to acquire 3D CT images at low dose, having a lot of space, and being able to use the large monitor. The addition of a new navigation system helps to create an even safer surgical environment. Compared to existing navigation systems, ClarifEye has no reference frame-related errors, and it’s wonderful that it achieves real time imaging with pedicle segmentation. ClarifEye is a new technology that truly offers minimally invasive surgery for patients and clinical staff procedure.”

“ClarifEye adds a new dimension in surgical precision for patients. It is a great example of how we are innovating procedures and helping clinicians to deliver on the Quadruple Aim of better health outcomes, improved patient and staff experiences, and lower cost of care.” said Karim Boussebaa, General Manager Image Guided Therapy Systems at Philips.

According to DelveInsight’s “Spine Augmentation Systems Market” report, the global spine augmentation system market was valued at USD XX million in 2021, growing at a CAGR of XX% during the forecast period from 2022 to 2027 to reach USD XX million by 2027. The growing demand for spine augmentation systems is primarily associated with the increasing percentage of geriatric and obese population, the rising prevalence of degenerative spine conditions such as osteoporosis, and increasing awareness among people about various spinal disorders and available treatments, among others; thereby propelling the market growth of spine augmentation systems during the forecast period.   

Medtronic’s Natural Conduction System for Heart Becomes the First to Receive FDA Approval 

On October 17, 2022, Medtronic, a global leader in healthcare technology, announced the U.S. Food and Drug Administration (FDA) approval for the cardiac lead that connects to the heart’s natural electrical system, providing patients with the therapy they need while avoiding risks like cardiomyopathy that can come with conventional pacing techniques. This method, also known as “conduction system pacing,” ensures that pacing closely resembles the heart’s natural contractions and enables the ventricles to cooperate.

The first and only business with therapies approved for conduction system pacing is Medtronic. The SelectSecureTM MRI SureScan® Model 3830 cardiac lead, a different type of conduction system pacing, was authorized by the FDA in 2018 for His-Bundle pacing. As an alternative to apical pacing in the right ventricle in a single- or dual-chamber pacing system, this cardiac lead is now approved for pacing and sensing at the bundle of His or in the left bundle branch area. Patients who have sluggish heart rates benefit from these implanted pulse generator systems.

Based on data from numerous sources spanning more than 20,000 treated patients, the expanded indication for left bundle branch region pacing was approved. The SelectSecure Model 3830 lead is now the first and only lead authorized for conducting system pacing.

“Conduction system pacing is more like simulating natural activation and can yield positive outcomes for patients. This approval signals to physicians that the Model 3830 lead is safe and effective for patients for conduction system pacing, and it may encourage more physicians to learn the procedure.” said Pugazhendhi Vijayaraman, M.D., F.H.R.S., director of electrophysiology at Geisinger Heart Institute in Wilkes-Barre, Pa.

Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies, said, “Physicians are telling us about their excitement for the future of pacemakers, which will rely on conduction system and leadless pacing. Expanded labeling of this lead allows us to train physicians to successfully perform left bundle procedures, bringing the benefits of conduction system pacing to more patients.” 

DelveInsight’s “Pacemakers Market” report provides an overview of pacemakers, their applications, advantages, and limitations. The global pacemakers market was valued at USD 4.88 billion in 2021, growing at a CAGR of 5.85% during the forecast period from 2022 to 2027 to reach USD 6.84 billion by 2027. The demand for pacemakers is motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological developments, thereby propelling the market growth of pacemakers during the forecast period. 

TissueCypher® Barrett’s Esophagus Test Results Significantly Increase Accuracy of Risk Assessments and Compliance with Recommendations for Patient Management, According to a Randomized Controlled Trial

On October 13, 2022, Castle Biosciences, a company improving health through innovative tests that guide patient care, announced the results from a randomized controlled trial (RCT) of TissueCypher® Barrett’s Esophagus Test that can significantly increase the doctor’s accuracy in determining the risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in patients diagnosed with Barrett’s oesophagus (BE), as well as adherence to guideline-recommended patient management techniques.

The only recognized cause that might lead to the onset of EAC is BE. EAC is an aggressive type of esophageal cancer with terrible prognoses. For individuals with a BE diagnosis, TissueCypher is a precision medicine test developed by Castle that forecasts HGD and/or EAC progression within five years.

Results from the randomized controlled trial depicted using a precision medicine diagnostic tool displayed increased adherence to guidelines in patients with Barrett’s oesophagus.

In the RCT, 259 doctors were divided into three groups and asked to rate clinical performance and value (CPV) vignettes featuring high- and low-risk patient situations according to clinical risk criteria. Based on recommendations from the American College of Gastroenterology (ACG) and the American Society of Gastrointestinal Endoscopy (ASGE), a quality-of-care percentage (0-100%) score was derived from the CPVs. After doctors received the TissueCypher test results, quality-of-care ratings considerably increased in all patient situations.

John W. Peabody, M.D., Ph.D., first study author and President of QURE Healthcare, said, “The study data showed that participants who ordered or received TissueCypher test results were up to 65.6% more likely to predict progression to HGD or EAC, (p<0.001), when compared to physicians who did not receive TissueCypher test results in our randomized trial. Importantly, subsequent to receiving test results and making their assessment, the intervention group was also more likely to adhere to guideline-recommended management strategies.”

“Barrett’s esophagus remains a persistent and real-world clinical challenge for endoscopists and patients. Individuals with non-dysplastic Barrett’s esophagus constitute the vast majority of cases, and for years, we have seen few updates in the management strategy of this patient population in particular. We were very excited to present the results of the QURE study, which help further demonstrate TissueCypher’s potential to meaningfully advance the care of this important patient population.” said Craig Munroe, M.D., gastroenterology medical director at Castle Biosciences. He further added, “We believe the clinical utility and objective information provided by our test can equip physicians with the information they need to make more informed treatment plan decisions and move beyond the limitations in the current standard of care for risk stratification of patients with BE.”

DelveInsight’s Cancer Diagnotics Marketreport provides an overview of cancer diagnostics, its applications, advantages, and limitations. The global cancer diagnostics market was valued at USD 125.13 billion in 2021, growing at a CAGR of 9.43% during the forecast period from 2022 to 2027 to reach USD 214.88 billion by 2027. The demand for cancer diagnostics is motivated due to the growing burden of cancers across the globe, the rising government initiatives across the globe, the growing number of manufacturers to develop advanced cancer diagnostics products in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and the growing technological developments in the product portfolio, thereby propelling the market growth of cancer diagnostics during the forecast period.