Centinel Spine® Completed Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

On June 13, 2023, Centinel Spine®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust and clinically-proven total disc replacement technology platform in the world, announced the completion of enrollment in a first-of-its-kind Investigational Device Exemption (IDE) study which aims to evaluate the safety and effectiveness of the prodisc C Vivo and prodisc C SK cervical total disc replacement (TDR) system.

The trial which enrolled 431 subjects at 29 sites throughout the US will be evaluating prodisc C Vivo and prodisc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

The trial allows surgeons to select from two different TDR control devices based on the patient’s anatomy, as well as other surgical factors to treat each surgical level individually.

Orthopedic spine surgeon Jason Tinley, MD, founder of the DFW Center for Spinal Disorders in Dallas-Fort Worth, Texas, said, “Each of my patients is unique in their cervical spine operative symptoms and anatomy. This IDE study was the first ever to evaluate the safety and efficacy of multiple total disc replacement devices that empower surgeons to tailor their surgical solution to the patient’s needs. I’ve found that prodisc C Vivo and prodisc C SK provide a powerful means to customize my surgical treatment to each patient.” 

“This is the first study ever to compare two different spinal devices to an approved TDR product, making it a unique opportunity to extend Centinel Spine’s Match-the-Disc™ cervical total disc replacement system to the treatment of two-level disease,” commented Centinel Spine CEO Steve Murray. Murray added, “The continued adoption of this cervical total disc replacement technology at one level propelled Centinel Spine to record revenues and a top market position in the first quarter of 2023. We look forward to further expanding the body of clinical evidence supporting this system and to enabling more surgeons to treat each patient’s unique needs.”

As per DelveInsight’s “Global Orthopedic Implants Market” report, the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2023 to 2028. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents and other injuries, and the growing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period (2023-2028).

BD Launched New Robotic System to Automate Clinical Flow Cytometry

On June 12, 2023, BD (Becton, Dickinson, and Company), a leading global medical technology company, announced the worldwide commercial launch of BD FACSDuet™ Premium System, a new automated instrument that prepares samples for clinical diagnostics using flow cytometry. 

The system uses liquid-handling robotics to automate the entire sample preparation process – including cocktailing, washing, and centrifuging – for both in vitro diagnostics (IVD) and user-defined tests and then automatically transfers samples to the physically integrated BD FACSLyric™ Clinical Flow Cytometry System, without human intervention. 

Due to its integration with the flow cytometer, the system allows a walkaway workflow solution with fewer manual processes, fewer resources, and less time.

Flow cytometry is considered an essential tool for clinical diagnostics and is often utilized in the diagnosis and management of diseases including cancer, and others. 

Steve Conly, worldwide president, of BD Biosciences said, “Our clinical customers have long trusted BD and our best-in-class products to standardize every step of the clinical lab workflow – from panel creation to sample preparation to analysis to report.” Steve added, “The flagship BD FACSLyric™ Flow Cytometry System is one of the fastest adopted clinical instruments in the world and now together with the FACSDuet™ Premium System, which has achieved IVD status in the U.S. and Europe, we usher in greater levels of automation so that our customers can focus more of their valuable time on analyzing and interpreting samples and impacting outcomes.” 

According to DelveInsight’s “Global Flow Cytometry Market” report, the global flow cytometry market was valued at USD 4,942.02 million in 2022, growing at a CAGR of 7.52% during the forecast period from 2023 to 2028 to reach USD 7,587.63 million by 2028. The increase in demand for flow cytometry is primarily attributed to the rising research and development activities in the healthcare industry. Further, the rising prevalence of chronic and immunological ailments like HIV & AIDS and cancer due to gene mutations, such as smoking, radiation, viruses, cancer-causing chemicals (carcinogens), obesity, hormones, chronic inflammation, and a lack of exercise. The diagnosis of HIV & AIDS and cancer is done by flow cytometry thereby increasing the demand for the device in the market. Additionally, the rising advancements in stem cell research and recombinant DNA technology in the development of cancerous and immunology drugs and increasing advancements in flow cytometry software such as providing high-resolution imaging, fluorescence, and laser technology, and others across the world are anticipated to bolster the market, thereby contributing to the growth of the flow cytometry market during the forecast period from 2023-2028.

Endologix Received FDA Approval for its Detour System 

On June 08, 2023, Endologix announced that it has received the US Food and Drug Administration (FDA) approval for its Detour system, described as a breakthrough in the treatment of peripheral arterial disease (PAD). 

The detour system offers a new approach called percutaneous transmural arterial bypass (PTAB) and is presently recommended for open surgical bypass, an invasive procedure.

The system treats patients with long (20 cm to 46 cm in length), complex superficial femoropopliteal lesions in an effective manner by allowing physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg.

Patients who have already undergone failed end-vascular procedures or patients that may be sub-optimal candidates for open surgical bypass can be treated with a detour system. 

“We are delighted to receive FDA approval of the Detour system,” commented President and CEO Matt Thompson, Endologix. Matt added, “PTAB therapy represents a significant step forward for patients with complex PAD, they have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the U.S. through a targeted market release in the coming weeks.” 

According to DelveInsight’s “Global Peripheral Artery Disease Market” report, the global peripheral artery disease market was valued at USD 3,757.64 million in 2022, growing at a CAGR of 6.64% during the forecast period from 2023 to 2028 to reach USD 5,469.02 million by 2028. The peripheral artery disease (PAD) market is observing remarkable market growth due to the factors such as the escalating burden of the geriatric population and the rising prevalence of peripheral artery disease (PAD) and arteriosclerosis across the globe. Further, the rising prevalence of obesity, diabetes, and high blood pressure, increasing product launches and approvals, and others will create a necessity for peripheral artery disease (PAD) in the market. Therefore, the market for peripheral artery disease (PAD) is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Reflow Medical’s DEEPER OUS Trial Evaluating Bare Temporary Spur Stent System Showed Positive Results at Six Months

On June 13, 2023, Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial which aims to evaluate the safety and efficacy of the Bare Temporary Spur Stent System. The results were presented in Leipzig, Germany.

The study of the Bare Temporary Spur Stent System used in combination with a commercially available paclitaxel-coated balloon met:

  • The primary effectiveness endpoint with an 86% primary patency rate at six months, and
  • The primary safety endpoint, i.e., freedom from target limb major adverse limb event (MALE) and all-cause perioperative death (POD) at 30 days, in 100% of subjects

The results based upon the treatment of 38 patients with a total of 40 lesions with the Bare Temporary Spur Stent System, showed: 

  • An impressive reduction in vessel recoil of more than 50%, 42.5% compared to previously reported rates of 97% with percutaneous transluminal angioplasty (PTA)
  • A trend toward improved six-month patency in subjects without vessel recoil

The system is designed and developed to deliver a temporary stent with integrated radial spikes to the peripheral vasculature via a sheathed delivery system, for stent-like results while leaving nothing behind.

Dr. Lichtenberg commented, “It’s gratifying to see the improvement in our patients six months after treatment with the Spur Stent System.” Dr. Lichtenberg added, “We observed improvements in their Rutherford class scores, and fewer than 8% required revascularization during the six months.” 

“We’re very grateful to Dr. Lichtenberg, Prof. Zeller, and the other investigators and teams involved in the trial, as well as to the patients for their participation,” said Teo Jimenez, Senior Vice President for Research and Development at Reflow Medical. Teo commented, “We’re looking forward to continuing to see great results from the study.”

According to DelveInsight’s  “Global Stents Market” report, the global stents market is estimated to grow at a CAGR of 5.61% during the forecast period from 2023 to 2028. The stents market is witnessing positive growth owing to the factors such as the increasing prevalence of chronic diseases, rise in the geriatric population, increasing demand for minimally invasive procedures, and increase in unhealthy lifestyles, thereby all factors contributing to the growth of the stents market during the forecast period from 2023-2028.

SunMed Acquired Avanos Medical’s Respiratory Health Business

On June 08, 2023, SunMed, a leading North American manufacturer and distributor of consumable medical devices for anesthesia and respiratory care, announced that the company has entered into a definitive agreement with Avanos Medical, Inc., under which SunMed will acquire Avanos’ respiratory health business, expanding the breadth of SunMed’s leading product offering, providing customers with a one-stop source for the most trusted and highest-quality brands in anesthesia and respiratory care, which support the best outcomes for patients.

The transaction allows SunMed to add market-leading brands including the BALLARD, MICROCUFF, and endOclear® product lines to its expansive and growing portfolio. 

The brands BALLARD, MICROCUFF, and endOclear® include closed suction catheters, endotracheal tubes, and oral care solutions, and have achieved strong trust, recognition, and respect among healthcare providers around the world for their high quality and advanced technology. 

Additionally, SunMed is acquiring two Avanos manufacturing facilities in Mexico and R&D expertise that support these brands. The proposed transaction, which is subject to customary closing conditions, is expected to be completed by late 2023.

Hank Struik, CEO of SunMed said, “Adding these complementary brands into our growing portfolio solidifies SunMed’s leadership as the premier manufacturer of the anesthesia and respiratory consumables that define product excellence and serve patients across the continuum of care.” Hank added, “These products are the standard-bearers of closed suction and endotracheal consumables, and we deeply admire the clinical results that these exceptional products provide for patients in critical care and the trust they have built with practitioners. Leveraging the expertise behind these successful brands, this transaction also supports our ability to drive growth and innovation, not just for the respiratory brands we are acquiring, but for our comprehensive breathing care platform. Combined with our expansive anesthesia and respiratory consumables business, we are further strengthening SunMed’s ability to serve more clinicians around the world, so they can provide the best patient outcomes.”

“Divesting our Respiratory Health business is a key element of Avanos’ ongoing three-year transformation process,” said Joe Woody, Avanos CEO. Woody mentioned, “We’re confident that SunMed is an excellent fit for our RH brands – including BALLARD*, MICROCUFF*, and endOclear® – and that these products will be strong additions to the company’s robust portfolio.”

According to DelveInsight’s “Global Anesthesia Machines Market” report, the global anesthesia machines market is estimated to advance at a CAGR of 8.2% during the forecast period (2023-2028). The rise in demand for anesthesia machines is primarily attributed to the growing burden of various surgeries that requires the administration of anesthesia to the patient during the operation among the worldwide population, increasing chronic diseases, and amassed old age population. In addition, an increase in investment and funds by the companies for the development of anesthesia machines are also the factors responsible for the global anesthesia machines market growth during the forecast period.

Smith+Nephew Received the US FDA clearance for the Shoulder Replacement System

On June 12, 2023, Smith+Nephew announced that it has received the US FDA 510(k) clearance for its Aetos shoulder system which is designed to restore patients’ range of motion and help minimize arthritic shoulder pain. 

Featuring the Aetos Meta Stem, the system offers maximum stability, preserves bone, and maintains patient anatomy. Adding to the company’s upper extremity portfolio, the Aetos system complements S+N’s sports medicine shoulder repair and biologics products and services. 

The system is cleared for both anatomic and reverse total shoulder arthroplasty. It offers a compact yet comprehensive portfolio of solutions that enhance the surgical experience. The Aetos shoulder system enables intraoperative flexibility and simplifies the operating room flow, as it requires fewer steps for conversion and fewer instruments for primary anatomic and reverse arthroplasty.

“Receiving FDA clearance for the Aetos shoulder system is a major milestone for Smith+Nephew. This platform is the culmination of years of research and development and represents our commitment to providing healthcare professionals with the best possible technology for their patients,” said Brad Cannon, president of global orthopedics for Smith+Nephew. Brad added, “We are confident that this platform will further evolve the standard of care for shoulder surgery and are excited to see the impact it has on patient outcomes.”

According to DelveInsight’s “Global Shoulder Replacement Devices Market” report, the global shoulder replacement devices market was valued at USD 1.80 billion in 2022, growing at a CAGR of 7.28% during the forecast period from 2023 to 2028, to reach USD 2.74 billion by 2028. The demand for shoulder replacement devices is primarily attributed to the rapid success rate and increase in the number of surgeries due to advancements in technology, the rising popularity of reverse total shoulder arthroplasty for rotator cuff arthropathy in the growing geriatric population due to the widespread occurrence of bone-related disorders, the prevalence of sports injuries and accidents, and growing medical infrastructure and medical facilities. Moreover, the growing life expectancy for the population and increasing cases of arthritis due to a sedentary lifestyle are the key reasons responsible for the development of the shoulder replacement sector.