GPX Embolic Device Success in Challenging Tumor Case

On January 20, 2022, In a multi-center clinical study, Fluidx Medical’s GPX Embolic Device was utilized to efficiently devascularize a massive tumor with several feeding vessels. The GPX Embolic Device is a cutting-edge embolic device that allows for easy preparation and precise delivery. The device is ready to use in a syringe, can be prepared tableside by the physician in approximately 30 seconds, and can be given using ordinary microcatheters (no complicated mixing systems or special delivery catheters are required). The GPX Embolic Device is still under development, and it has yet to get marketing authorization or approval in any market. Only for research purposes (in New Zealand).

Martin Krauss, M.D., Head of Interventional Radiology, Christchurch Hospital, Christchurch, New Zealand, said,  “This could have been a challenging case since it involved a large renal tumor fed by small, low flow, tortuous vessels.  We were able to use our standard embolic microcatheter to deliver GPX in a highly controlled fashion.  Since we were not worried about catheter entrapment, we could take our time and ensure that we occluded all targeted vessels completely.  GPX flowed distally very well, completely filling the targeted region. Based on our case experiences, GPX is a great product for effectively filling distal vasculature.”

Libble Ginster, CEO of Fluidx Medical Technology, said, “Treating a tumor with multiple feeding vessels in a controlled, thorough manner without risk of catheter entrapment can improve patient care and minimize the need for follow-on procedures. GPX demonstrates improved control and precision. GPX does not require 20+ minutes of preparation time or the clinician to use a special catheter system.  The simplicity of GPX preparation makes real-time clinical decision-making possible. We continue to be excited about the GPX portfolio and its future in advancing cancer care.”

According to DelveInsight’s ‘Transcatheter Embolization And Occlusion Devices Market Insights and Competitive Landscapereport, the global Transcatheter Embolization And Occlusion Devices market was valued at USD 3.71 billion in 2020, growing at a CAGR of 9.14% during the forecast period from 2021 to 2026, to reach USD 6.25 billion by 2026. The demand for Transcatheter Embolization and Occlusion Devices is primarily attributed to the rising technological advancement, surge in the prevalence of chronic diseases like cardiovascular diseases, respiratory disorders, and cancer, highly structured health care industry, increased adoption of minimally invasive surgeries, and increasing geriatric population across the globe. In addition, as per the Delveinsight analyst, Non-Coiled Transcatheter Embolization and Occlusion Devices are expected to hold a significant market share attributed to the use of these devices as this helps avoid complications, among others.

Cardiovascular Systems, Inc., and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

On January 20, 2022, Cardiovascular Systems, Inc. and OrbusNeich Medical Company Ltd announced FDA PMA approval of OrbusNeich’s Scoreflex®NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (Scoreflex NC). Scoreflex NC is a dual-wire focused force PTCA scoring balloon with a focal stress pattern that allows for safe and controlled plaque alteration at lower resolution pressure. Scoreflex NC is used to improve myocardial perfusion by dilating a de novo stenotic segment of a coronary artery and treating in-stent restenosis in patients with coronary ischemia.

Dr. David Kandzari, Chief of the Piedmont Heart Institute and Cardiovascular Service Line; Director, Interventional Cardiology of the Piedmont Heart Institute; and Chief Scientific Officer for Piedmont Healthcare in Atlanta, Ga., and Principal Investigator of the study, said, “The pivotal study demonstrated the effectiveness of Scoreflex NC to safely modify stenotic coronary arteries, demonstrating excellent deliverability, luminal gain, and a high rate of procedural success. Scoreflex NC will be a welcomed addition to the interventional toolbox to treat complex coronary artery disease.”

David Chien, OrbusNeich’s CEO and Chairman said, “We are extremely pleased to receive FDA PMA approval for our Scoreflex NC device and are delighted to introduce this scoring balloon to U.S. physicians through our distribution partner, CSI.” In our continued commitment to delivering innovative products that can change the lives of many patients, we are confident our product will provide increased treatment options.”

According to DelveInsight’s “Balloon Catheters Market Insight and Competitive Landscape,” report, B. Braun Melsungen AG, Boston Scientific Corporation, Medtronic, among others are the key players operating in the Balloon Catheters market. The significant drivers of the global balloon catheter market are the increasing incidences of cardiac diseases, the rising geriatric population, growing demand for minimally invasive surgery, and increasing government initiatives like favorable reimbursement policies. Technological advancements and increasing R&D are also expected to drive the market. Additionally, the patient population suffering from end-stage renal disease of which the majority of these patients undergoing catheters surgery is also likely to increase the use of balloon catheters for treatment.

Successful First-In-Human Use of BENDIT21 Neurovascular Catheter Performed at the University of Texas Southwestern Medical Center

On January 20, 2022, The BENDIT21 neuro catheter was successfully used in a life-saving therapy for the first time in the United States, according to BENDIT Technologies. The patient in this instance was a 57-year-old woman who had been suffering from an inoperable symptomatic internal carotid artery aneurysm for years. Due to its three-dimensional clinician-controlled movement and independent control of catheter tip deflection, the BENDIT steerable microcatheter is designed to provide access to difficult-to-reach vascular sites. These improved capabilities are designed to allow surgeons to explore the brain, peripheral, and coronary vasculature efficiently and accurately.

Dr. John Barr, Professor of Radiology and Neurological Surgery, UT Southwestern Medical Center, used the BENDIT21 steerable microcatheter under compassionate use granted by the FDA, said, “We were pleased to be granted FDA approval for the compassionate use for this first case in the U.S. Previous access attempts had failed both here at UT Southwestern and at an outside facility because the neck of the giant aneurysm could not be crossed using other catheters.” 

Yossi Mazel, CEO of the Petach Tikva-based medical device company added, “This first-in-human case in the US together with other cases done in Israel and Europe, has demonstrated the potential of our steerable microcatheter to access torturous anatomies. This feature allows successful endovascular treatments in most complex situations and demonstrates how our catheter can ease access and intra vascular navigation.”

According to DelveInsight’sNeurovascular Catheters Devices Market Insight and Competitive Landscape” report, Medtronic, Stryker, Terumo Corporation among others are the key players operating in the Neurovascular Catheters Devices market. The increasing prevalence of neurological conditions such as brain aneurysm and stroke, the adoption of an unhealthy lifestyle, increasing awareness among the population about the treatment of neurological conditions, increasing disposable income, and new product launch by the key market players are some of the prime factors driving the market.

Cook Medical receives FDA breakthrough designation for new drug-eluting stent

On January 21, 2020, The US Food and Drug Administration (FDA) has given Cook Medical’s innovative drug-eluting stent for below the knee (BTK), a Breakthrough Device designation. This novel stent is intended to help patients with chronic limb-threatening ischemia (CLTI).

Mark Breedlove, vice president of Cook Medical’s Vascular division, said, “CLTI is a debilitating disease of growing prevalence around the globe and this is Cook Medical’s latest innovation within our peripheral artery disease (PAD) program,” This new product leverages our deep understanding of stent design and drug elution for lower limb anatomies, and it complements our dedicated portfolio of BTK products for limb preservation. Our goal is to improve the long-term clinical outcomes for CLTI patients.” 

According to DelveInsight’s “Drug-Eluting Stents Market Insight and Competitive Landscapereport, in 2019, Cardiovascular Diseases were the leading cause of death across the globe accounting for an estimated 17.9 million deaths which represent 32% of all the global death. The increase in demand for Drug-Eluting Stents is predominantly attributed to the rise in the prevalence of cardiovascular disorders, increasing geriatric population; technological advancement in the product line, increase in demand for minimally invasive surgeries, among others are anticipated to bolster the demand for these stents thereby leading to an increase in the global market for Drug-Eluting Stents during the forecasted period.

Zimmer Biomet’s ZimVie spinoff moves forward

On January 21, 2022, Zimmer Biomet Holdings, Inc. has filed a Form 10 registration statement with the US Securities and Exchange Commission (“SEC”) in conjunction with the planned spinoff of its Dental and Spine businesses as ZimVie, a separate publicly listed company.

In addition, on Monday, February 7, 2022, from 11:00 a.m. to about 3:00 p.m. Eastern Time, ZimVie will hold a virtual Investor Day. The virtual event will have presentations by ZimVie executives highlighting the company’s Dental and Spine services, as well as the addressable market potential, financial forecast, business strategy, and the broader organizations that support these businesses. ZimVie has applied to have its stock listed on the Nasdaq under the ticker ZIMV.

Zimmer Biomet will receive a USD 501 million cash payment from ZimVie as part of the acquisition, putting the new company’s debt at USD 561 million.

In February 2021, Zimmer Biomet announced its intention to create a new independent, publicly listed firm to better allocate resources and achieve market leadership. The transaction is still on track, with a completion date set for the first quarter of 2022.

Smith+Nephew’s PICO◊ 7 and PICO 14 Negative Pressure Wound Therapy Systems are the first systems indicated to aid in reducing the incidence of both deep and superficial incisional surgical site infections and dehiscence

On January 24, 2022, Smith+Nephew, a worldwide medical technology company announced that its PICO 7 and PICO 14 Single Usage Negative Pressure Wound Therapy (sNPWT) Systems now have additional indications for use.

The U.S. Food and Drug Administration (FDA) cleared the systems for use on closed surgical incisions, to aid in reducing the incidence of:

  • Superficial and deep incisional surgical site infections (SSIs) for high-risk patients in Class I and Class II wounds
  • Post-operative Seroma
  • Dehiscence

Dr. Bashyal, Director of Outpatient Total Joints, NorthShore University Health System, Chicago, Illinois, said, “As a high-volume elective hip and knee replacement surgeon, I am sending more patients home the same day with outpatient surgery. The PICO System has been a game-changer in managing closed incisions in my practice by helping to reduce the incidence of wound complications including drainage, seromas, and superficial infections.”

The PICO 7 sNPWT System showed statistical effectiveness when compared to traditional dressings in meta-analyses studies, including a decrease in the incidence of superficial and deep incisional SSIs for class I and class II wounds. The PICO System also lowered the risk of seroma and dehiscence after surgery.

PICO sNPWT has been used on an estimated 2.3 million surgical incisions, helping to avoid surgical site problems. The PICO System has reduced hospital stays while also saving healthcare systems costs on nursing time and resources. Additionally, the PICO System is beneficial in lowering the incidence of surgical site infection for up to 7 days.

According to DelveInsight’s “Negative Pressure Wound Therapy Systems Market Insights and Competitive Landscape report, the global Negative Pressure Wound Therapy Systems market was valued at USD 3.19 billion in 2020, growing at a CAGR of 5.03% during the forecast period from 2021 to 2026, to reach USD 4.28 billion by 2026. Factors such as the rising incidence of chronic wounds associated with various chronic disorders such as diabetes, ulcers, obesity, and also with the rising incidence of active wounds comprising burns, surgical wounds, among others are driving the overall NPWT market growth in the coming years. Further, an increase in the aging population, increasing awareness of proper wound care management, rising funding for wound care research, and technological advancements in wound care product offerings are also driving the market.