Providence Medical Technology Completed Enrolment in the FUSE Clinical Study for High-Risk Cervical Fusion Patients 

On May 11, 2023, Providence Medical Technology, Inc. (PMT), a leader in medical device innovation for spine surgery, closed the enrolment in its FUSE Study which is a prospective, multicenter, randomized, investigational device exemption (IDE) clinical study evaluating the safety and effectiveness of its Posterior Cervical Stabilization System (PCSS) in 3-level cervical fusion patients. To compare PCSS combined with anterior cervical discectomy and fusion (ACDF) to ACDF alone in superiority research, almost 230 patients were included among 18 top spinal surgical centers in the United States.

The study was started in May 2020, to assess level-1 clinical evidence for circumferential cervical fusion (CCF) in high-risk cervical fusion patients. The study covers patients who, due to risk factors such as 3-level illness, smoking, advanced age, and diabetes, are at risk for failure of a routine ACDF fusion treatment. While the success rate of a regular ACDF operation is typically favorable in patients who are otherwise healthy, it is noticeably less so in these high-risk patients. About 30% of the more than 300,000 anterior cervical fusion surgeries carried out each year involve patients who have serious risk factors for non-union. 

In addition to the ACDF, this study is examining whether these patients would benefit from a posterior cervical fusion that spares tissue.

The first comparative analysis for fusion and other clinical outcomes will occur when 100 patients reach two years of follow-up. The 100th patient is scheduled to return for their two-year follow-up visit at the end of 2023.

Half of the patients in the FUSE Study received anterior fusion surgery involving a plate and screws, a common surgery and the current standard of care. The other half received an anterior fusion plus a posterior fusion using the company’s CORUS™ Spinal System and PCSS titanium implants. The CORUS Spinal System is a unique set of instruments used to perform a tissue-sparing posterior cervical fusion. The Posterior Cervical Stabilization System (PCSS) is an investigational device consisting of non-segmental instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PCSS achieves bilateral facet fixation by spanning the interspace at each level, with points of fixation at each end of the construct.

“The completion of FUSE enrolment is an important milestone for high-risk spinal fusion patients,” said Jeff Smith, CEO and Founder of Providence. Jeff further added, “At Providence, we are on a mission to establish CCF as the standard of care for high-risk patients. We believe these patients require more and are hopeful the FUSE results will raise awareness of the extensive unmet need in the treatment of patients with risk factors for nonunion. These are normal patients seen by surgeons routinely, however, are often excluded from spine fusion clinical studies because it is well-understood that they have worse outcomes. The FUSE Study is the largest ever level-1 study on high-risk cervical fusion patients, and I am proud of our multi-year commitment and our amazing progress to date. We are grateful to our dedicated team of surgeons, research coordinators, nurses, contractors, and support staff who worked tirelessly on this mission. We look forward to performing our initial analysis of this superiority study.”

“I have enjoyed being a part of the FUSE study. I have been impressed with my personal experience using the CORUS Spinal System and am looking forward to assessing the impact of the PCSS implants on clinical outcomes in one and two years. Being a part of this study has caused me to re-think how I treat patients requiring cervical fusions who are at a somewhat higher risk of not fusing. In my practice going forward, those higher-risk patients will very likely be getting a posterior cervical fusion using the CORUS Spinal System as an adjunct to ACDF.

K. Brandon Strenge, MD, The Orthopaedic Institute of Western Kentucky (FUSE Study Investigator).

“Congratulations to Providence, the investigators, and most importantly, the patients for reaching this amazing milestone. This has been an exciting study to participate as a principal investigator. I am eager to start analyzing the data and reporting the overall outcomes. This study has the potential to produce impactful discoveries in the coming months and years.

Pierce D Nunley, MD, Director, Spine Institute of Louisiana (FUSE Study Investigator).

I have used the CORUS Spinal System for less invasive posterior cervical fusion for some time, and it has been the most impactful change in my practice, for the better. As part of the FUSE study, I look forward to evaluating the effect CORUS may have in combination with PCSS implants for 3-level high-risk patients.

Alex Lemons, MD Orthopaedic Surgery, Pinehurst Surgical Clinic (FUSE Study Investigator)

“This study is designed to ultimately determine the value of 360 fusion in high-risk patients and the use of minimally invasive techniques to deliver better outcomes for our patients. I believe this technique offers less morbidity than lateral mass screw fixation. This could provide benefit to this underserved, high-risk patient population,

Jamieson Glenn, MD, Orthopaedic Spine Surgeon, Scripps, Encinitas (FUSE Study Investigator).

As per DelveInsight’s “Spinal Implants Market” report, the global spinal implants market was valued at USD 13.01 billion in 2022, growing at a CAGR of 5.40% during the forecast period from 2023 to 2028 to reach USD 17.84 billion by 2028. The rise in demand for spinal implants is predominantly attributed due to the increasing prevalence of various spinal disorders which include spinal stenosis, degenerative disc diseases, and disc herniation, among others in the older population across the globe. Moreover, shifting focus toward technological advancement in bone graft products, rising awareness among the patient population regarding the spinal disorder and their proper management, and rising preferences for minimally invasive surgeries are the factors driving the spinal implant market.

Shockwave Medical Launched New Coronary IVL Catheter 

On May 15, 2023, Shockwave Medical, Inc., a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced the full commercial availability of the Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter to treat severely calcified coronary artery disease in select international markets.

The company designed its C2+ coronary IVL catheter to treat severely calcified coronary artery disease using pulsatile sonic pressure. Santa Clara, California-based Shockwave, which has been subject to recent acquisition speculation, launched the catheter in select international markets.

Shockwave C2+ is commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies.

“Shockwave C2+ maintains the intuitive catheter design and ease of use that are foundational to the success of Shockwave IVL and incorporates improvements that will enhance procedural efficiency and optimize the treatment of the most challenging morphologies,” said Dr. Jonathan Hill, MD, consultant cardiologist at the Royal Brompton Hospital in London. Dr. Jonathan also said, “The extra pulses are most advantageous in areas with the highest burden of calcium, including nodular, eccentric, diffuse, and multivessel calcium.”

According to DelveInsight’s “Indwelling Catheters Market” report, the global indwelling catheters market was valued at USD 1.44 billion in 2022, growing at a CAGR of 8.78% during the forecast period from 2023 to 2028 to reach USD 2.38 billion by 2028. Factors such as the rising geriatric population, rising prevalence of kidney diseases and bladder disorders, increasing number of surgical procedures being performed, and technical innovation in product development such as the manufacture of coated indwelling catheters with antimicrobial activity among other factors are expected to drive the indwelling catheters market.

Abbott Received FDA Approval for its Spinal Cord Stimulation Systems to Treat Chronic Back Pain in People Who Have Limited Surgical Options

On May 16, 2023, Abbott, a global healthcare leader that helps people live more fully at all stages of life, announced that the US Food and Drug Administration (FDA) has approved the company’s spinal cord stimulation (SCS) devices for the treatment of chronic back pain in people who have not had or are not eligible to receive back surgery, known as non-surgical back pain.

Results from the DISTINCT research showed that Abbott’s patented BurstDR SCS technology improved pain levels, daily activity usability, and emotional well-being in persons with chronic back pain, providing support for this labeling expansion. BurstDR is a form of stimulation therapy that uses pulses or bursts of mild electrical energy without an abnormal sensation of tingling (also known as paresthesia) to change pain signals as they travel from the spinal cord to the brain.

The largest randomized controlled trial using SCS in patients with persistent back pain when surgery is not an option was conducted by Abbott in the DISTINCT research, which involved 270 participants who had experienced pain for an average of 12.8 years. In the first 200 patients, results at six months supported BurstDR stimulation therapy’s effectiveness as a treatment for chronic back pain, and these results persisted at the 12-month follow-up. Important conclusions from the DISTINCT study also included:

  • 72.6% of people in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction compared to only 7.1% in the conservative medical management arm
  • 91.4% of people who received SCS therapy obtained significant pain relief or significantly improved function
  • On average, people who received SCS therapy experienced a 69.7% reduction in pain

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” said Timothy Deer, M.D., FIPP, DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. Timothy Deer also added, “This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain.”

This FDA expanded indication approval for our SCS devices is a significant step forward in Abbott’s goal to provide treatment access to those who suffer daily with chronic back pain but are not eligible for corrective surgery.

Pedro Malha, vice president, of neuromodulation, at Abbott

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 2022, growing at a CAGR of 8.70% during the forecast period from 2023 to 2028 to reach USD 3.72 billion by 2028. 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, and cause a reduction in patient discomfort, with no side effects 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. 

Onward Completed First-In-Human Use of Movement-Restoring Lead

On May 15, 2023, ONWARD Medical N.V., the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), announced the successful first-in-human use of its investigational ARC-IM Lead.

The ONWARD ARC-IM system, a cutting-edge platform designed to offer ARC Therapy to treat various indications, includes the ARC-IM Lead, which delivers focused electrical pulses to the spinal cord. The ARC-IM Lead is made specifically for use with the ARC-IM neurostimulator (IPG) and has parameters tailored for each anatomical region along the spinal cord to activate the dorsal roots. For the many indications the company is developing or investigating, such as enhanced blood pressure management, mobility, upper extremity function, and bladder control, ONWARD is building a portfolio of ARC-IM Leads in a variety of sizes, shapes, and electrode arrays.

The shape and electrode placement of the ARC-IM Lead is unique, providing characteristics I have long wanted for my patients with spinal cord injury while exhibiting the same feel as the leads I have implanted for many years.

Jocelyne Bloch, MD, a neurosurgeon at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland.

“The purpose-designed ARC-IM Lead will unlock our ability to optimally deliver ARC Therapy to address many of the challenges faced by people with spinal cord injury,” said Dave Marver, CEO of ONWARD. Dave Marver also said, “We look forward to using the lead to pursue restoration of mobility and other indications in the future.”

According to DelveInsight’s “Deep Brain Stimulation Devices Market” report, the global deep brain stimulation devices market was valued at USD 1.31 billion in 2022, growing at a CAGR of 10.40% during the forecast period from 2023 to 2028 to reach USD 2.37 billion by 2028. The demand for deep brain stimulation devices is witnessing growth owing to the growing prevalence of movement disorders such as Parkinson’s disease, expansion of disease indications for DBS therapy, rising geriatric population, and increasing research and development activities in product development are expected to aid in the growing demand for DBS devices leading to the growth of the DBS devices market during the forecast period.

Beckman Coulter Launched New Immunoassay Analyser 

On May 16, 2023, Beckman Coulter, a clinical diagnostics leader, unveiled the DxI 9000 Access Immunoassay Analyzer, the most productive immunoassay analyzer per footprint. 

The DxI 9000 Analyzer can run up to 215 tests per hour per square meter (tests/hr/m2).

Modern needs for speed, reliability, reproducibility, quality, and menu extension are met by the DxI 9000 Analyzer advancements. The platform has been independently confirmed to operate at the highest level of EFLM performance evaluation, known as the optimal level, according to the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). The unique Lumi-Phos PRO Substrate has demonstrated the capacity to create assays that are more sensitive and clinically relevant over time, ensuring that the system will be able to satisfy healthcare needs in the future.

The analyzer is currently available in most countries across the globe. DxI 9000 Analysers can connect to DxS IntelliServe, Beckman Coulter’s newly designed remote service and diagnostics solution. This advanced system monitors data and error trends, as well as enables timely and proactive servicing when required. It detects service experts who can address issues through real-time monitoring, remote operation, and troubleshooting. This maximizes the uptime and enhances the performance of laboratories.

The DxI 9000 Access Immunoassay Analyzer sets new expectations for immunoassay testing operational performance and ability to develop and sustain improved assay sensitivity to meet tomorrow’s analytical needs. Those in the laboratory will treasure ZeroDaily Maintenance to save them time, PrecisionVision Technology to safeguard against flawed data reports, and IntelliServe to maximize system uptime. At the same time, clinical researchers are excited about the DxI 9000 Analyzer’s capability to keep pace with increasingly sensitive testing requirements as healthcare providers and pharmaceutical companies aim for ever more challenging diseases. An inspiring feat of technology, the DxI 9000 Analyzer is a comprehensive healthcare innovation.

Julie Sawyer Montgomery, President, of Beckman Coulter Diagnostics

According to DelveInsight’s “Chemiluminescence Immunoassay Market” report, the global chemiluminescence immunoassay market is estimated to grow at a CAGR of 8.83% during the forecast period from 2023 to 2028. The chemiluminescence immunoassay market is slated to witness prosperity owing to factors such as the growing prevalence of diseases such as cancer, diabetes, and cardiovascular diseases, among others. Further, the rising awareness of health especially after the COVID-19 pandemic, and the growing focus on improving the accuracy, portability, affordability, and usability of chemiluminescence immunoassay for end-users are expected to result in appreciable revenue growth in the chemiluminescence immunoassay market during the forecast period (2023-2028).

Regen Lab Received CE Certification for Three PRP Solutions 

On May 16, 2023, Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing, and commercialization of proprietary tissue engineering products, announced that the REGENKIT®, CELLULAR MATRIX fig®, and Arthrovisc® have obtained the CE marked certification.

The PRP solutions received the certificates from the notified body BSI based on the evaluation of Regen Lab’s quality management system and technical documentation.

REGENKIT® is a preparation of Platelet-Rich Plasma (PRP), CELLULAR MATRIX fig®, a combination of PRP and Hyaluronic Acid (HA), and Arthrovisc®, HA-filled syringes.According to DelveInsight’s “Platelet Rich Plasma (PRP) Market” report, the global platelet rich plasma (PRP) market was valued at USD 413 million in 2022, growing at a CAGR of 10.18% during the forecast period from 2023 to 2028 to reach USD 736 million by 2028. The demand for platelet-rich plasma (PRP) is primarily being boosted by the increasing figures of patients suffering from orthopedic diseases, sports injuries, acute and chronic wounds, gynecological diseases, and urological diseases, among others. In addition, the growing need for PRP in various aesthetic procedures such as cosmetic facials, facial rejuvenation, acne scars, facial scarring, facelift and rhytidectomy, rhinoplasty, hair restoration, fat grafting, and other aesthetic procedures, the increasing product launches and approval among others are thereby contributing to the overall growth of the platelet-rich plasma (PRP) market during the forecast period from 2023-2028.