Micro Medical Solutions Announced Completion of Enrollment in Pivotal STAND Clinical Trial

On December 6, 2023, Micro Medical Solutions (MMS) made an announcement on the completion of a pivotal clinical study enrollment in the United States. MMS microvascular intervention is intended to improve clinical outcomes and quality of life in patients with CLI / CLTI in the US comparing the safety and efficacy of the MicroStent technology to PTA (percutaneous transluminal angioplasty), the current gold standard of treatment. The MicroStent system is already approved for usage in the EEA with a CE mark.

The last patient was enrolled in STAND (a clinical evaluation of MicroStent Peripheral Vascular Stent in participants with below-the-knee vascular disease) earlier this month, bringing the trial to a close. A vascular stent called a MicroStent is intended to attain and preserve patency in the tibiofibular arteries, hence promoting wound healing and blood flow and minimising below-knee amputation in patients suffering from progressive peripheral artery disease (PAD)-related critical limb ischemia (CLI).

“I would like to thank the investigators and research teams for their dedication, participation, collaboration and tremendous effort in helping this complex and difficult patient population. I am excited to continue providing research expertise to the company and discuss the study results when they become available,” said lead researcher Dr. Robert E. Beasley of Palm Vascular Centers in Miami Beach, Florida.

“CLI/CTI is the most severe clinical manifestation of PAD. We are excited to see how the data develop to better understand the impact of angiosome-directed endovascular intervention and its impact on wound healing, limb salvage, and independence of life for the patient. We warmly thank our patient population who participated in the study. The goal of the study has always been to demonstrate a lower amputation rate, thereby reducing the devastating mortality rate associated with limb loss,” commented Rita Jacob, vice president of Clinical Affairs.

“This is an encouraging step forward for MMS, the millions of patients who battle CLI every day, and the physicians who treat and care for these patients,” said CEO Gregory Sullivan. “MMS developed the MicroStent platform in response to patient needs and we are excited to move closer to putting the MicroStent in the hands of American interventionalists treating CLI.”

As per DelveInsight’s “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 a positive growth owing to the factors such as increasing prevalence of chronic diseases, rise in geriatric population, increasing demand of minimally invasive procedures, increase in unhealthy lifestyle, thereby all factors contributing to the growth of stents market during the forecast period from 2023-2028. 

Kaneka Acquired Japan Medical Device Technology 

On November 30, 2023, Kaneka Corporation acquired all shares of Japan Medical Device Technology Co, Ltd., a developer and manufacturer of medical devices, and made it a wholly-owned subsidiary.

Kaneka produces and markets endovascular catheters, which are devices used in the treatment of cardiac, peripheral vascular and cerebrovascular diseases. In particular, stenting for the treatment of coronary heart diseases such as atherosclerosis represents a 30 billion yen market in Japan, and Kaneka aims to expand its business in this area.

JMDT enjoys high technological capabilities in the research and development of coronary stents and is one of the leaders in the development of bioresorbable stents.

A tubular metal mesh stent is often positioned over the lesion to expand the lumen and improve blood flow in coronary arteries. If restenosis recurs, it is frequently impossible to implant a new stent in the same spot because the original one is still in the blood vessel. The magnesium alloy utilised in JMDT’s bioresorbable stent is biodegradable, which reduces the possibility of vessel blockage brought on by the stent staying in the conduit. Furthermore, 1.5 years after implantation, the body reabsorbs and absorbs 95% of the stent, guaranteeing that it does not obstruct the treatment for restenosis.

The bioresorbable stent from JMDT has a reduced risk of thrombosis due to its thin [100 µm] but fully expandable stent body, which is constructed of a very safe magnesium alloy. A layer covering its surface regulates the elution of the medicine (sirolimus) and the deterioration of the magnesium alloy. Furthermore, it is the only bioresorbable stent in Japan at the moment that has advanced to the FIH [First In Human] study in preparation for initial human usage.

According to DelveInsight’s “Central Venous Catheters Market” report, the global central venous catheters market was valued at USD 2.73 billion in 2022, growing at a CAGR of 6.85% during the forecast period from 2023 to 2028 to reach USD 4.04 billion by 2028. The central venous catheters market is slated to witness prosperity owing to factors such as growing prevalence of chronic diseases such as cancer, cardiovascular and kidney diseases among others, increasing sedentary lifestyle, rising number of blood transfusions, and rising number of technological advancements with respect to the products are further expected to result in the appreciable revenue growth in the central venous catheters market during the forecast period (2023-2028). 

Tandem Diabetes Care Launched t:slim X2 Insulin Pump Software with Dexcom G7 CGM Integration in U.S. 

On December 6, 2023, Tandem Diabetes Care launched the updated t:slim X2 insulin pump software with Dexcom G7 Continuous Glucose Monitoring (CGM) integration in the United States. Tandem’s top-rated automated insulin delivery (AID) system with Control-IQ technology is the only AID option in the world today to use Dexcom’s latest CGM technology.

Tandem will provide all in-warranty parties email instructions and offer the free option to add the new feature via remote software update to t:slim X2 users in the United States. New clients will now be receiving t:slim X2 pumps that are pre-loaded with the latest firmware.

“With this launch we are offering more than 300,000 current t:slim X2 users the ability to integrate with Dexcom’s most advanced CGM technology, demonstrating our commitment to continued leadership in advancing AID systems,” said John Sheridan, president and chief executive officer of Tandem Diabetes Care. “As we celebrate our 10-year partnership with Dexcom, we remain committed to sustaining our rapid pace of innovation to further our mission of helping improve the lives of people with diabetes.”

With the integration of Dexcom G7, t:slim X2 insulin pump users can now:

  • Spend more time in closed loop with little to no wait time between Dexcom G7 CGM sensor sessions.
  • Use either a Dexcom G6 or Dexcom G7 CGM sensor, allowing even more choice in their diabetes management.

Dexcom G7, which is 60 percent smaller than its Dexcom G6 predecessor, offers a range of new features, including:

  • Improved accuracy
  • A 30-minute sensor warmup time, compared to 2 hours previously
  • A 12-hour grace period to replace finished sensors for a more seamless transition between sessions and flexibility for when to change sensors

“The Dexcom G7 and t:slim X2 insulin pump integration is the culmination of years of partnership and a shared commitment to improve the lives of people with diabetes,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “We’re excited to bring our newest technology to Tandem users so they can experience the benefits of the smallest, most accurate, easy to use CGM connected to AID systems.”

The t:slim X2 pump with Dexcom G7 integration is expected to launch in additional countries outside the U.S. in early 2024.

According to DelveInsight’s “Insulin Infusion Pumps Market” report, the global insulin infusion pumps market was valued at USD 6.48 billion in 2022, growing at a CAGR of 8.69% during the forecast period from 2023 to 2028 to reach USD 10.68 billion by 2028. The insulin infusion pumps market is slated to witness prosperity owing to factors such as growing prevalence of diabetes, increasing sedentary lifestyle, growing aging population base which is susceptible to the development of diabetes, and the growing focus on improving the safety and usability of insulin infusion pumps are further expected to result in the appreciable revenue growth in the insulin infusion pumps market during the forecast period (2023-2028).

AcelRx Pharmaceuticals Announced Publication of Study Evaluating Anticoagulation Practices for Continuous Renal Replacement Therapy in the United States

On December 12, 2023, AcelRx Pharmaceuticals announced the publication of a quantitative market research study evaluating current U.S. physician anticoagulation use during continuous renal replacement therapy (CRRT) in patients with acute kidney injury in the intensive care unit. 

Heparin is the sole FDA-approved anticoagulant for dialysis circuits, and it has a 1-3 hour half-life. Because heparin circulates back into the patient from the dialysis circuit, causing anticoagulation in the patient, which is frequently harmful, it is consequently categorised as a “systemic” anticoagulant. Citrate is categorised as a “regional” anticoagulant by the FDA because its anticoagulant action is limited to the circuit and is reversed by a calcium infusion given to the patient. As a result, the FDA has granted an Emergency Use Authorization (EUA) for citrate.

The publication, entitled “Anticoagulation Practices for Continuous Renal Replacement Therapy: A Survey of Physicians from the United States,” is lead authored by Dr. David Boldt, and published in the journal Renal Failure. Dr. Boldt is an Associate Professor at the University of California, Los Angeles School of Medicine, Critical Care Intensivist and Division Chief of Trauma and Adult Multi-Specialty Anesthesiology. In the study, a total of 150 U.S. board-certified physicians consisting of critical care medicine specialists (n=80) and nephrologists (n=70) who specialize in CRRT were surveyed by MedSurvey from November to December 2022 regarding their current CRRT anticoagulation practices.

 This study resulted in a number of key findings:

  • CRRT machine use increased by approximately 30% from pre-pandemic era to late 2022.
  • On average, physicians use heparin in the CRRT circuit for 43% of patients, with citrate being used in 28% of patients and no anticoagulation used in 29% of patients.
  • The top reason for use of heparin is that it is readily available, but concerns with heparin included systemic bleeding and heparin-induced thrombocytopenia, which were ranked 3.5 and 3.4 respectively, on a 1-5 scale of “not challenging” to “very challenging”.
  • Hypocalcemia (52% of physicians) and citrate safety (42% of physicians) were ranked as the top two reasons for not using citrate in heparin-intolerant patients. Physicians who do use citrate reported that hypocalcemia occurs in 37% of patients.
  • When no anticoagulation is used in the CRRT circuit, 84% of physicians stated filter clogging was a problem and almost a quarter of the physicians stated an increase in transfusions was required as a result.

One of the study’s drawbacks was that it was an online survey; still, in order to participate, doctors had to answer eight screening questions confirming that they were board-certified in nephrology or critical care medicine, had experience working in an ICU, and were knowledgeable about the procedures and details of using CRRTs in their respective hospitals.

“It is clear from this study that physicians in charge of CRRT at their institutions are not completely satisfied with the currently available anticoagulants, heparin and citrate, for use in the dialysis circuit,” stated Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. “Niyad as a potentially new regional anticoagulant for patients who cannot tolerate heparin could provide a meaningful improvement to the current standard of care in this field. Allowing physicians to avoid the complexities associated with citrate and reducing the number of patients who receive no anticoagulation by offering a new alternative can hopefully improve the quality of CRRT for these very fragile patients.”

Dr. Boldt stated, “We really don’t have any great choices as it relates to CRRT anticoagulation, which is why I am excited about the potential approval of Niyad as a new anticoagulant option. Nafamostat’s ultra-short half-life of 8 minutes and its limited systemic effect could really change how we approach anticoagulation of CRRT circuits. Heparin is fraught with potentially significant, and often life-threatening, complications such as systemic bleeding and heparin-induced thrombocytopenia, as well as heparin resistance, all of which make using heparin challenging in many patients.” Dr. Boldt continued, “While citrate avoids the risk of systemic bleeding, its complicated administration protocol, requirement for a calcium infusion, frequent testing of calcium levels, and citrate toxicity risks can lead many clinicians to avoid its use altogether.”

According to DelveInsight’s “Continuous Renal Replacement Therapy Machines (CRRT) Market” report, the global Continuous Renal Replacement Therapy (CRRT) Machines Market was valued at USD 1.25 billion in 2022, growing at a CAGR of 7.39% during the forecast period from 2023 to 2028, to reach USD 1.92 billion by 2028. The demand for CRRT machines is predominantly attributed to the rise in the prevalence of acute renal failure or Acute Kidney Injury (AKI) across the globe, the growing burden of ICU patients with AKI along with an increase in the incidence of sepsis, significant technological advancements in the product line. The clinical advantage of CRRT over intermittent blood purification systems is also a prominent driving factor for the CRRT machines market.

ZimVie Announced Compatibility between its Vital Spinal Fixation System and Brainlab Spine & Trauma Navigation 

On December 12, 2023, ZimVie Inc. received FDA clearance for its Vital Spinal Fixation System including instruments for use with Brainlab Spine & Trauma Navigation. 

In order to achieve compatibility between ZimVie’s Vital and Virage systems and Brainlab Spine & Trauma Navigation, which aids surgeons in the planning and execution of spinal procedures, the precise placement of pedicle screws, and the reduction of radiation exposure, the companies’ Development Cooperation Agreement was executed as of March 2023.

With its Vital and Virage lines, ZimVie intends to co-market Brainlab Spine & Trauma Navigation. The first vital sets are anticipated to be released in the US in early 2024. After obtaining such approval, the business intends to apply for a 510(k) to the FDA for Virage the following year.

“This is a positive milestone for both teams and the first of what we hope will be many FDA clearances for compatibility. The strong collaboration between our organizations resulted in an expedited project timeline,” said Rebecca Whitney, Global President of ZimVie Spine. “We have been focused on expanding our portfolio with enabling technologies to drive greater adoption, and I am excited to see the team advance toward the launch.” 

According to DelveInsight’s “Neurovascular Devices Market” Report, the global neurovascular devices market was valued at USD 2.84 billion in 2022, growing at a CAGR of 8.12% during the forecast period from 2023 to 2028, to reach USD 4.53 billion. The demand for neurovascular devices is gaining importance owing to the rising prevalence of the target patient population, increasing demand for minimally invasive neurosurgical procedures, ongoing development of technologically advanced products, and rising R&D investments, among others.

NeuroOne Received FDA 510(k) Clearance to Market its OneRF™ Ablation System

On December 11, 2023, NeuroOne Medical Technologies Corporation received U.S. Food and Drug Administration (“FDA”) 510(k) clearance to market its OneRF Ablation System for creation of radiofrequency (“RF”) lesions in nervous tissue for functional neurosurgical procedures.

“When NeuroOne was founded, one of our ambitious goals was to be the first to develop and commercialize thin-film electrodes capable of performing both diagnostic and therapeutic functions and offer a better methodology to treat patients suffering from a variety of neurological conditions,” said Dave Rosa, CEO of NeuroOne. 

“We believe we have the potential to dramatically change the way these surgeries are performed so that patients may only need to go through surgery once for both diagnostic and therapeutic procedures. This may also reduce hospital stays, number of surgeries, and adverse events, while offering significant benefits from a clinical perspective. The addition of temperature control at the point of ablation also may enhance patient safety. Our team’s achievement in reaching this milestone was the culmination of years of perseverance, and I could not be more excited for our future. We are now preparing for a commercial launch either directly or through a strategic partner in the first half of calendar 2024.”

Robert E. Gross, MD, PhD, chair of the Department of Neurosurgery at New Jersey Medical School and Robert Wood Johnson Medical School said, “The FDA clearance of NeuroOne’s OneRF system will provide neurosurgeons with an important new tool in the surgical management of epilepsy, with the ability to provide ablative therapy using already implanted depth electrodes used for diagnosing the epileptic focus as part of stereoEEG. This may lead to improved outcomes for patients with potential for fewer interventions, and an improved therapeutic window.”

The OneRF Ablation System is the third FDA-cleared device and the company’s first with a therapeutic indication. With a comprehensive range of electrode technologies, NeuroOne can now treat patients who need RF ablation with the same sEEG electrode for diagnostic brain mapping operations. Apart from the OneRF Ablation System, Evo cortical and sEEG electrode product lines from NeuroOne are other FDA-cleared devices that are mostly utilised for recording brain activity for shorter than 30 days.

According to NeuroOne, the global brain ablation industry is currently worth at least USD 100 million and is expanding quickly. Given the high number of addressable patients with unmet clinical needs, the market has the potential to increase several times over.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 2023 to 2028. 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 2023 to 2028.