Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia 

On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.

Bernard Ross, CEO and Founder, said that achieving this latest 510(k) clearance is a major milestone for Sky, which will enable them to start a controlled market release of the geko™ device to address venous insufficiency and ischemia in the first instance, a therapy area sorely in need of innovation. With this 510(k) and in partnership with leading US clinicians, they can now press ahead to redefine the way vascular-related conditions can be treated.

The geko™ device is an easy-to-use, non-invasive, wearable therapy device with the size of a wristwatch and worn at the knee. It is a disposable device that gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, leading to an increased blood flow in the deep veins of the calf. The device operates without external pressure to the leg and allows complete mobility.

According to DelveInsight’s “Critical Limb Ischemia Market, critical limb ischemia is found in approximately 12% of the U.S. adult population, with men affected slightly more than women. Moreover, the prevalence of the indication is high in the geriatric population.

BD launched a new MX instrument for infectious diseases testing 

On December 17, 2021, BD (Becton, Dickinson, and Company), a leading global medical technology company, announced the expansion of the BD COR™ System to incorporate a new MX instrument for high-throughput molecular testing for infectious diseases. The new instrument and its first test for sexually transmitted infections have received CE marked to the IVD directive 98/79/EC.

The leading test available on the MX instrument is the BD CTGCTV2 for BD COR™ System, which is intended to use a single test to detect the three most prevalent non-viral sexually transmitted infections, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV).

Nikos Pavlidis, vice president of Molecular Diagnostics at BD, commented that the BD COR™ PX/GX system is already utilised at laboratories across Europe and Israel to enhance diagnostics and positively influence patient care. The availability of the MX instrument expands the use of the platform. It automated testing for an expanding list of high-demand, essential assays for women’s health and STI testing using multiplex PCR assay design, commencing with BD’s CTGCTV2 test.

According to DelveInsight’s Molecular Diagnostic Market & Competitive Landscape, the global molecular diagnostic market is valued USD 9.56 billion in 2020, increasing at a CAGR of 9.21% during the forecast period from 2021 to 2026, to touch USD 16.12 billion by 2026. The demand for molecular diagnostics is increasing because of the growing incidence of infectious diseases such as the sudden outbreak of COVID-19 and the increasing burden of cancers globally. Moreover, rapid technological advancement in the molecular diagnostic product arena and rising demand for point-of-care diagnostics, along with increasing consumer awareness regarding quick diagnostics and the launch of new molecular diagnostic systems, among others, are some of the critical factors responsible for the molecular diagnostic market growth during the forecasted period.

Fist Assist Devices obtains FDA “Breakthrough Device” designation for the world’s first wearable Vein Dilation Device for ESRD patients  

On December 16, 2021, Fist Assist Devices, LLC, a medical device company focused on vein dilation to ease the Chronic Kidney Disease (CKD) patient’s journey through End-Stage Renal Disease (ESRD), secured Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the First Assist Model FA-1 device.

Hrishikesh Gadagkar, Ph.D., Fist Assist regulatory advisor and CEO, Idonea Solutions, said that this is a first-of-its-kind wearable device for hemodialysis patients zeroed in on pre-surgery vein dilation; they are ecstatic to have the FDA identify this innovative approach to vein dilation and the potential of this therapeutic wearable device supporting the patient’s journey through ESRD. They appreciate the FDA’s thorough review of Fist Assist’s Breakthrough Device designation request and seek a collaborative relationship as the company develops its FDA de novo classification application.

Dr. Tej Singh, Founder, and CEO of Fist Assist Devices, LLC, commented that this designation is another significant milestone for Fist Assist Devices, LLC. They anticipate it to modify the algorithm for patient care. The recently published data from the FACT trial on stage 4 vein dilation and pFACT trial on perforator vein dilation validates the value of intermittent vein compression to CKD patients. The FA-1 device benefits patients, physicians, and health care delivery systems since more prominent veins confer patients more treatment options regarding surgical or endoAVF procedures. Eventually, their goals are to advantage patients, achieve better results, and have more hope. This Breakthrough Designation gets them one step closer to accomplishing our goals.

The Fist Assist Model FA-1 device is an intermittent pneumatic compression wearable device to promote vein dilation. It is an automated device that compresses the outflow vein with biological and physiological benefits. 

According to DelveInsight’s “Chronic kidney disease (CKD) Market, approximately 10 million people across the globe are affected by CKD. Around 2 million people receive treatment with dialysis or a kidney transplant worldwide. Moreover, it is also estimated that the increase in the old age population in the Asia Pacific countries would substantially increase kidney failure cases.

Zynex Monitoring initiated enrolment in a Hemodialysis clinical trial for its Fluid Monitoring System 

On December 20, 2021, Zynex, Inc., an innovative medical technology company operating in the manufacturing and marketing of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, initiated enrollment in a hemodialysis clinical trial with its fluid monitoring system, CM-1500. DaVita Clinical Research clinics are conducting the study, which is aimed at characterizing deviations in the device’s patented Relative Index during hemodialysis procedures where a large volume of fluid is removed from patients. 

In February 2020, the company received FDA clearance for CM-1500, a non-invasive monitor intended to monitor patients’ fluid balance in hospitals and surgical centers.

Thomas Sandgaard, the CEO, Chairman, and Founder, said that engaging in these trials will refine their devices and technology and push the monitoring division forward to serve patients better worldwide. They are excited to take this next step in innovating the clinical value.

Donald Gregg, VP of Zynex Monitoring Solutions, added that investing in clinical evidence is critical to articulating how their device performs in multiple care settings. The hemodialysis population is of particular interest because of the controlled setting and known volume removed from patients regularly.

Zynex Monitoring Solutions initially targets operating rooms and surgeries that typically display substantial blood loss along with recovery rooms and intensive care units where internal bleedings are more common and difficult to detect until serious complications occur. The study is expected to complete enrolments in the first quarter of 2022.

According to DelveInsight’s ‘Hemodialysis Catheter Market & Competitive Landscape“, the market leaders in the segment Fresenius Se & Co. Kgaa, B. Braun Melsungen Ag, Baxter International Inc., Nipro Medical Corporation, Toray Medical Co., Ltd., among others.

Edwards obtains FDA approval for Sapien 3 with Alterra Present for Transcatheter Pulmonic Valve Replacement 

On December 20, 2021, Edwards Lifesciences announced the approval from the US Food and Drug Administration (FDA) for using the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive present (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation.

Dr. Evan Zahn, M.D., Director of Guerin Family Congenital Heart Program at the Smidt Heart Institute, Cedars-Sinai Medical Center, and principal investigator for the ALTERRA clinical trial said that the FDA approval of the SAPIEN 3 with Alterra is excellent news for patients worldwide, many of whom have endured several surgical procedures for congenital heart disease treatment. The outstanding outcomes achieved by SAPIEN 3 with Alterra will expand the range of patients who need pulmonary valve replacement that they can now treat with minimally invasive therapy. This will lead to significant improvements in quality of life and a decrease in the number of surgeries and procedures that congenital heart patients need throughout their lifetime.

The Edwards SAPIEN 3 TPV system with Alterra adaptive present is indicated for use in the management of adult and pediatric patients with severe pulmonary regurgitation as measured by echocardiography, who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.

According to DelveInsight’s ‘Transcatheter Aortic Valve Replacement/Implantation Market & Competitive Landscape”, global Transcatheter Aortic Valve Devices Market was worth to be USD 2.80 billion in 2020, increasing at a CAGR of 15.41% during the forecast period from 2021 to 2026 to touch USD 6.60 billion by 2026. The transcatheter aortic valve replacement devices demand is rising because of the increasing aortic stenosis disorder prevalence, rise in cardiovascular diseases, increasing demand for TAVR procedures, rising aortic regurgitation prevalence, and the technological advancements about the transcatheter aortic valve replacement arena, are anticipated to increase in the product demand.

GE Healthcare completes acquisition of BK Medical

On December 21, 2021, GE finished its previously declared acquisition of BK Medical, a leader in advanced surgical visualization, from Altaris Capital Partners, LLC. The companies entered into a definitive agreement where GE purchased BK Medical for a cash purchase price of USD 1.45 billion on September 22, 2021.

Roland Rott, President, and CEO of GE Healthcare Ultrasound, said that they are thrilled to bring their extraordinary teams together, learn from each other and continue to build on their deep, shared expertise as they grow their portfolio that their customers turn to and trust.  Together as one family, they are looking forward to an even brighter future.

Brooks West, President and CEO of BK Medical, said that they have been on a journey to change the standard of care for surgery by making it possible for surgeons to make critical decisions in the operating room using advanced real-time visualization, enabling better care, faster surgeries, and decreased complications.  Together with GE, this journey will continue, and they can look forward to making a more significant impact in healthcare worldwide.

The company’s acquisition added the fast-growing and relatively new field of real-time surgical visualization to GE’s pre-and post-operative Ultrasound capabilities.

Foldax® announced the publication of the first clinical results for its TRIA™ biopolymer heart valve

On December 21, 2021, Foldax®, Inc. announced the publication of the first clinical results for its TRIA™ biopolymer heart valve – the first polymer valve to be implanted in humans. The early feasibility study indicated that the TRIA surgical aortic valve met its primary endpoints at one year, comprising enhancement in valve effective orifice area (EOA), clinically significant improvement in New York Heart Association (NYHA) class, and safety. The company published the data in the December 2021 issue of the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.  

Dean Kereiakes, MD, FACC, FSCAI, lead author on the publication and President of The Christ Hospital Heart and Vascular Institute at The Christ Hospital Health Network in Cincinnati, Ohio, summarized the study results that the heart valve options they have today are not perfect. Mechanical valves require daily utilisation of anticoagulants, which may violate on patient lifestyles and are associated with major bleeding complications, while tissue or bioprosthetic valves have limited durability. The biopolymer valve they studied proffers the potential to enhance patient outcomes, as the polymer and design work together to optimize the properties and performance of the valve leaflets. The TRIA valve showed marked and sustained improvements in transvalvular gradients, valve EOA and NYHA clinical class out to one-year following valve implant. Safety outcome measures appear comparable to those reported for bioprosthetic (animal tissue) heart valves.

Frank Maguire, Chief Executive Officer of Foldax, said that they are pleased that the TRIA valve showed the best hemodynamics it was designed to achieve and expected to see in its first clinical study. The combination of their novel, proprietary polymer, optimized design, and robotic manufacturing promises a level of performance, durability, and precision that has never been seen before in a prosthetic heart valve. They seek to see results from the expanded study early next year and move forward with their U.S. pivotal trial next year.

The TRIA valves are the first and only heart valves to be robotically manufactured, decreasing variability and allowing high precision, repeatability, and quality, while substantially enhancing the economics of heart valve manufacturing.According to DelveInsight’s “Transcatheter Aortic Valve Replacement Devices Market & Competitive Landscape”, the global Transcatheter Aortic Valve Devices Market was valued at USD 2.80 billion in 2020, growing at a CAGR of 15.41% during the forecast period from 2021 to 2026 to reach USD 6.60 billion by 2026. The transcatheter aortic valve replacement devices demand is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular diseases, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation, and the technological advancements about 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 2021-2026.