Edwards Pascal Precision Transcatheter Mitral And Tricuspid Valve Repair System Receives CE Mark

On August 17, 2022, Edwards Lifesciences Corporation, an American medical technology company headquartered in Irvine, California, specializes in artificial heart valves and hemodynamic monitoring. The company announced that it has received CE mark approval for its PASCAL Precision transcatheter valve repair system for the treatment of mitral and tricuspid regurgitation (MR and TR).

Through a single delivery system, the PASCAL Precision system is used to treat patients with mitral or tricuspid regurgitation. The new system is made to allow for precise navigation and delivery of implants.

The PASCAL Precision system consists of the PASCAL and PASCAL Ace implants, which include independent grasping, atraumatic clasp and closure, and implant adaptability, such as the capacity to elongate and navigate difficult anatomy. One of many transcatheter repair or replacement treatments being developed by Edwards to treat mitral and tricuspid valve disorders is the PASCAL Precision system. A strong amount of clinical evidence underpins the company’s commitment to revolutionizing the treatment of patients with mitral and tricuspid disease.

Delivering the PASCAL Precision system to clinicians in Europe marks another significant step in our partnership with physicians who treat the large population of patients with mitral and tricuspid valve disease,” said Bernard J. Zovighian, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “Edwards has a long history of innovation, and the significant advancements in the PASCAL Precision system are designed to improve clinicians’ ability to provide positive outcomes for patients with both MR and TR.”

The PASCAL Precision system provides significant advancements in operator experience with implant delivery,” said Prof Jörg Hausleiter, Professor of Medicine and the Deputy Clinic Director at the Ludwig-Maximilians University in Munich, Germany. “Having successfully treated my first patient with the PASCAL Precision system, I found it easy to operate and the improved catheter response and stability gave me greater control to place the implant exactly where I needed to.”

As per DelveInsight’s Transcatheter Aortic Valve Replacement/Implantation Marketreport, the global transcatheter aortic valve devices market was valued at USD 3.23 billion in 2021, growing at a CAGR of 15.41% during the forecast period from 2022 to 2027 to reach USD 7.64 billion by 2027. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders prevalence, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation, and the technological advancements of the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2022-2027.

Boston Heart Diagnostics Launches LipidSeqTM— An NGS Test for Common Genetic Disorders of Lipid Metabolism 

On August 17, 2022, Boston Heart Diagnostics Corporation, a subsidiary of Eurofins Scientific (EUFI.PA) is revolutionizing the way cardiovascular disease and related conditions are treated by offering healthcare professionals and their patients novel, personalized diagnostics and integrated, customized lifestyle programs that have the potential to alter how clinicians and patients discuss the disease and enhance health.

The company announced the release of LipidSeqTM, a ground-breaking genetic test for heart disease. The most prevalent genetic causes of lipid and lipoprotein problems are found with this saliva-based NGS test. These conditions are linked to early kidney, pancreatic, cardiovascular, and neurological illnesses. LipidSeq was created in conjunction with Dr. Robert A. Hegele of the London, Ontario-based Robarts Research Institute and with the assistance of Clinical Enterprise, a laboratory partner of Eurofins that handles the genetic sequencing.

Numerous disorders, including familial types of excessive cholesterol, lysosomal acid lipase deficiency, and HDL deficiency conditions such as ApoA-I deficiency, can be detected by the 23-gene test. If the patient’s condition has a genetic component, the test can aid in understanding the particular mutation and the related disease to help inform therapy choices.

According to DelveInsight’s “In Vitro Diagnostics Marketreport, the global in vitro diagnostics market was valued at USD 71.01 billion in 2021, growing at a CAGR of 4.71% during the forecast period from 2022 to 2027, to reach USD 93.60 billion by 2027. The in vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities for in vitro diagnostics among others.

Rocket VR Health Partners with Penn Medicine’s Abramson Cancer Center to Study the Use of VR in Patients Undergoing Radiation Therapy

On August 19, 2022, Rocket VR Health, a digital therapeutics company developing immersive therapy programs, is collaborating with Penn Medicine’s Abramson Cancer Center to explore the use of virtual reality (VR) technology in cancer patients receiving radiation therapy.

Rocket VR’s immersive meditation program will be administered as part of a feasibility study with 25 patients before receiving daily treatments, utilizing the HTC VIVE Flow VR headset. By utilizing mindfulness meditation in nature, the imagery and sounds encountered are intended to create an immersive environment. The pre-procedure wait time can be made into a soothing VR meditation experience with the help of this procedural relaxation and distraction solution. Patients will complete surveys before and after their procedures to rate their overall experience, and staff will be judged on their capacity to use this technology for radiation therapy patients.

We are thrilled to be working with the talented research team at Penn Medicine as well as the HTC Vive Flow, one of the lightest and most ergonomic headsets on the market,” said Nik Vassev, COO and Co-Founder of Rocket VR Health. “Our solution aims to improve the radiation therapy experience, which at times can be anxiety-provoking.”

Our study aims to demonstrate the feasibility and validity of delivering VR-enhanced meditation to reduce anticipatory anxiety experienced by patients undergoing radiation therapy to help improve patient well-being during what is certainly one of the most stressful times in their lives,” said William Levin, MD, an associate professor in the Department of Radiation Oncology at the Perelman School of Medicine at Penn. “Because radiation therapy is challenging when the patient is anxious and unable to lay still, we hope to gauge how well patients can slow their breathing for a more comfortable experience.

According to DelveInsight’s Cancer Diagnostic Marketreport, the global cancer diagnostic 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 increase in demand for cancer diagnostic products and services is predominantly attributed to the spike in the cancer cases reported worldwide. In addition, growing manufacturers’ focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others are anticipated to drive the global cancer diagnostic market during the forthcoming years.

FDA Approves Abbott’s New Spinal Cord Stimulation Device; Provides Tailored Relief to Multiple Pain Areas and Adds More Treatment Options for Evolving Pain Conditions 

On August 23, 2022, Abbott, a global healthcare leader helps people live more fully at all stages of life. The company announced that the U.S. Food and Drug Administration (FDA) has approved its new Proclaim™ Plus spinal cord stimulation (SCS) system featuring FlexBurst360™ therapy. The next generation of Abbott’s proprietary BurstDR™ stimulation, FlexBurst360 therapy provides pain relief in up to six different locations of the trunk and/or limbs and allows programming that may be changed as a person’s therapeutic needs change.

The Proclaim Plus SCS system is recharge-free and has a battery that can last up to 10 years. It is made to fit into a person’s life. It is compatible with Abbott’s NeuroSphereTM Virtual Clinic connected care technology, which enables remote real-time stimulation settings delivery and secure in-app video conferencing with medical professionals.

Spinal cord stimulation has provided tremendous relief for patients suffering from chronic pain. With its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game-changer in this space, helping to not only improve a patient’s ability to perform everyday activities but also relieve the emotional suffering§ that pain can cause,” said Steven Falowski, M.D., Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, Pa. “However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened by pain because of multiple painful areas and evolving pain over time. Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time.”

According to DelveInsight’s Spinal Cord Stimulators (SCS) Market” report, the global Spinal Cord Stimulators (SCS) Market was valued at USD 2.25 billion in 2021, growing at a CAGR of 8.70% during the forecast period from 2022 to 2027 to reach USD 3.72 billion by 2027. The demand for Spinal Cord Stimulators (SCS) is primarily attributed to the growing number of patients with chronic pain, and neuropathic pain in the shoulder, legs, and knee. The technologically advanced devices that are non-invasive, eliminate targeted pains, cause a reduction in patient discomfort, with no side effects, and are likely responsible for a boost in the Global Spinal Cord Stimulators (SCS) Market growth. Moreover, favorable government regulations for commercialization and launching products in the market and the rising geriatric population are some of the factors responsible for propelling the growth of the Spinal Cord Stimulators (SCS) Market.

Imagin Medical Announces Acquisition of the enCAGE Coil™ Precision Ablation System for Prostate Cancer and a New $7.25M Convertible Note to Finance Its Development 

On August 22, 2022, Imagin Medical Inc., a urologic oncology company, announced the acquisition of the enCAGE Coil™ Precision Ablation System for Prostate Cancer from TROD Medical NV, a Belgian company. The enCAGE Coil™ Precision Ablation System includes a Prostate ablation procedure that is used to treat prostate cancer. Energy (such as heat, cold, lasers, or chemicals) is utilized during prostate ablation surgery to eliminate the cancer cells. Some of the normal prostate tissue in the area may also be destroyed by the energy.

The enCAGE Coil device provides bipolar radiofrequency radiation through a distinctive “coil” electrode during a minimally invasive office-based operation. It is a disposable focal therapy precision ablation device for prostate cancer. The system addresses the shortcomings of other types of thermal ablation technologies for prostate cancer that run the risk of damaging adjacent structures, such as the erectile nerves that regulate urinary and sexual function, by allowing the surgeon to pre-set precise ablation margins to target only the cancerous tissue.

As a Urologist who has cared for patients with cancer over a 25-year career as a Professor and Urological Oncologic surgeon, I have a deep knowledge of the field and the needs of patients with prostate and bladder cancer,” said Dr. Kevin Slawin, Chairman of the Board of Imagin. “Our growing focus on bringing best-in-class technologies to patients in an outpatient setting is the culmination of my thoughts over my career as a leader in the field of Urologic Oncology on how to best care for these patients.”

According to DelveInsight’s “Ablation Devices Market” report,  the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2022 to 2027. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmia such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2022 to 2027.

Thermedical Announces FDA Approval of Clinical Trial for SERF Ablation to Treat Patients with Ventricular Tachycardia, Leading Cause of Sudden Cardiac Death

On August 22, 2022, Thermedical, a developer of thermal-ablation systems to treat ventricular arrhythmias announced the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to assess the safety and effectiveness of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to conventional treatment. VT is an abnormally rapid heart rhythm that is a leading cause of sudden cardiac death globally.

SERF ablation with the Durablate catheter will be investigated as a treatment option for patients with ventricular arrhythmias resistant to antiarrhythmic drugs or standard ablation procedures. It provides a new form of biological heat transfer made to be more efficient than conventional ablation methods. The Durable catheter has been created to deliver energy with a high level of accuracy to better control the ablation size and treat tissue deeper in the heart wall where life-threatening arrhythmias that cause VT are often located.

We are grateful to the FDA for the rapid approval of this pivotal trial to evaluate our Saline Enhanced Radiofrequency (SERF) Ablation System in patients who have run out of treatment options for their VT episodes and who suffer from extremely poor quality of life,” said Michael Curley, Ph.D., FHRS, co-founder and CEO of Thermedical, and senior author of the first-in-man multi-center trial evaluating SERF with the Durablate catheter, published in Circulation: Arrhythmia and Electrophysiology. “In our recent multi-center trial, 31 of 32 participants experienced immediate elimination of their clinical VT at the end of the procedure, and therapies such as shock or pace regulation were reduced by 89% during the five-month follow-up in these patients.”

This larger clinical trial is very important to further the evaluation of this innovative approach to treating problematic VT to reduce or eliminate shocks that implantable cardioverter defibrillators deliver to this patient population,” continued Dr. Curley. “We are encouraged by the early data and are eager to further demonstrate the safety and efficacy of our promising new SERF technology. Furthermore, SERF offers hope to people who suffer from this condition, as it could be life-changing for the treatment of refractory VT.”

According to DelveInsight’s “Cardiac Ablation Devices Market” report, the global cardiac ablation devices market was valued at USD 2.25 billion in 2021, growing at a CAGR of 12.77% during the forecast period from 2022 to 2027, to reach USD 4.63 billion by 2027. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Further, growth in new therapies, technological advancements, increasing geriatric population, and penetration and acceptance of cardiac ablation devices in emerging countries will drive the market growth. Cardiac ablation devices were found to be extremely beneficial in heart failure cases in COVID-19 which further pushed the demand for these devices during the pandemic situation.