Apyx Medical Corporation Received FDA 510(k) Clearance for the Use of Renuvion® for Coagulation of Subcutaneous Soft Tissues Following Liposuction for Aesthetic Body Contouring
On April 28, 2023, Apyx Medical Corporation, the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, received 510(k) US Food and Drug Administration clearance for the utilization of the Renuvion APR Handpiece for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring purposes.
With this, the Renuvion APR handpiece became the only device to have a 510(k) clearance for use following liposuction.
Charlie Goodwin, President, and Chief Executive Officer, of Apyx Medical Corporation, said, “We are pleased to receive 510(k) clearance for the use of the Renuvion APR Handpiece for coagulation of subcutaneous soft tissues specifically following liposuction for aesthetic body contouring. The Renuvion APR handpiece is the only device to have a 510(k) clearance for use following liposuction.” Goodwin added, “This 510(k) clearance further demonstrates the safety and effectiveness of our Renuvion technology and our continued commitment to working with the FDA to secure specific clinical indications.”
As per DelveInsight’s “Body Contouring Devices Market” report, the global body contouring devices market was valued at USD 1.40 billion in 2021, growing at a CAGR of 7.34% during the forecast period from 2022 to 2027 to reach USD 2.25 billion by 2027. The increase in demand for body contouring devices is primarily attributed to the rising prevalence of obesity worldwide due to unhealthy lifestyles, which will increase the demand for the devices in the market.
Additionally, a rise in awareness regarding non-invasive and minimally invasive body contouring procedures, a surge in aesthetic consciousness and its demand, and improved safety and efficacy of these techniques across the world are anticipated to bolster the market, thereby contributing to the growth of the body contouring devices market during the forecast period from 2022-2027. As per the Delveinsight analysis, in the product type segment of the body contouring devices market, the non-invasive segment is estimated to hold a significant share of the body contouring devices market in the year 2021. This can be ascribed to the various advantages that are associated with the segment. Non-invasive body contouring devices are safe, cost-effective, and give less pain experience to the patients as the procedures require zero cuts on the skin.
Concept Medical Received IDE Approval to Investigate the Safety and Efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the Treatment Of Small Coronary Artery Disease
On April 25, 2023, Concept Medical Inc., was granted investigational device exemption (IDE) approval by US FDA for its novel MagicTouch Sirolimus Coated Balloon (SCB) which is intended for the treatment of Small Vessels (SV) in coronary arteries.
The MagicTouch SCB is the first Sirolimus-coated balloon in the world, and it is widely used in commerce in Europe, key Asian markets, and Middle Eastern markets. In these markets, MagicTouch SCB has treated more than 100,000 patients.
Small Vessel Disease is commonly witnessed in patients undergoing percutaneous coronary intervention (PCI) procedures and also remains an independent predictor of major adverse cardiac events (MACE).
In addition to this most recent IDE approval for the treatment of small vessel indication, Concept Medical also received two other IDE approvals for the MagicTouch SCB family of products for the treatment of below-the-knee indication (PTA) and coronary in-stent restenosis (ISR) indication.
With IDE approval, Concept Medical intends to initiate the pivotal clinical study to support the safety and effectiveness of the MagicTouch SCB in small vessel coronary disease. The data generated from this IDE clinical study will support a future pre-market approval (PMA) application in the USA.
FDA-approved drug-coated balloons for the treatment of CAD are currently unavailable in the USA. Only uncoated balloons and Drug Eluting Stents are available to doctors. The EASTBOURNE Registry (2123 patients), NANOLUTE, and current trials like the TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and Hybrid Bifurcation DEB have all extensively researched MagicTouch SCB on a global scale. The therapy of coronary artery disease with sirolimus has already been shown to be safer.
The FDA-approval to initiate the MAGICAL-SV Clinical trial using the MagicTouch sirolimus-covered balloon with novel coating technology represents a landmark event in our decades-long quest to find an optimal therapy to manage patients with small vessel coronary obstructive disease. Our US clinical investigators are thrilled and anxious to begin enrolment in close collaboration with the Cardiovascular Research Foundation and Concept MedicalDr. Martin Leon, MD (Founder and Chairman Emeritus, Cardiovascular Research Foundation), who will lead the coming IDE Trials
According to DelveInsight’s “Balloon Catheters Market” report, the global balloon catheters market was valued at USD 4.60 billion in 2021, growing at a CAGR of 8.78% during the forecast period from 2022 to 2027 to reach USD 7.62 billion by 2027. Factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, growing geriatric population base where age itself plays a major role in disease etiology and technical innovation in product development such as the manufacture of drug-coated balloon catheters aimed at drug delivery at the site of action among other factors are expected to drive the balloon catheters market.
Eitan Medical Launched the Connected Avoset™ Infusion Platform
On April 27, 2023, Eitan Medical, a global leader in advanced infusion therapy and drug delivery solutions with reliable innovations that put patients at the center of care, announced the launch of its new cutting-edge connected infusion multi-therapy ambulatory infusion system Avoset™.
With compact and simplified technology that can monitor infusion treatment data remotely, the connected Avoset™ Infusion System is designed to transform post-acute care and aims to enhance patient safety and improve the user experience.
The Sapphire Infusion portfolio is completed by the AvosetTM Infusion Platform, which is particularly well suited to satisfy infusion requirements for therapies that demand safe pharmaceutical reservoirs and long battery life at modest flow rates. The MDR-certified Avoset Infusion Pump is now offered in a few European nations. In 2023, Eitan Medical anticipates launching Avoset on a global scale.
The recent spinout of Eitan Medical’s Sorrel wearable injection device business, allows Eitan Medical to focus on its core connected infusion system solutions. The launch of Avoset will transform infusion therapy in alternate sites and is not only a triumph of innovation and technology but also a testament to the dedication of Eitan Medical to providing the best possible care for patients. It is a moment of excitement and hope, as we look forward to the transformative impact these solutions will have on the lives of many patients and caregivers around the world.Shaul Eitan, GM and President of Eitan Medical, Medication Delivery Solutions
We are thrilled to launch the Avoset Infusion Platform, an innovative connected ambulatory infusion pump that will transform the way patients receive treatment in post-acute care. We are confident that this new infusion pump will make a positive impact on the lives of patients and their caregivers, providing them with the freedom and flexibility to manage their treatment from the comfort of their own homes. This confirms that Eitan Medical is set for sustainable growth with a focus on a strong innovation roadmap that will redefine the drug delivery market.Roger Massengale, Chief Commercial Officer of Eitan Medical
According to DelveInsight’s “Infusion Pumps Market” report, the global infusion pumps market was valued at USD 13.80 billion in 2021, growing at a CAGR of 9.54% during the forecast period from 2022 to 2027, to reach USD 23.85 billion by 2027. The demand for infusion pumps is primarily motivated by the increasing prevalence of chronic diseases, the increase in the demand for remote patient monitoring, growing research and development activities to launch home infusion systems, and the increasing cost of hospital-based infusion therapies.
Medtronic Received FDA Approval for its Next-generation Micra Leadless Pacing Systems
On May 1, 2023, Medtronic plc, the global leader in medical technology, got the US Food and Drug Administration (FDA) approval for its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniaturized, leadless pacemakers.
The tiniest pacemakers in the world, the Micra AV2, and Micra VR2, offer a longer battery life and simpler programming than previous Micra models while still providing the many advantages of leadless pacing, such as fewer problems compared to conventional pacemakers.
The median expected battery life of the Micra AV2 and Micra VR2 is about 16 and 17 years, respectively, with over 40% greater battery life compared to earlier generations. According to projections, more than 80% of individuals who receive a Micra will only require one device for the rest of their lives.
Advanced algorithms that automatically program AV synchronization and so synchronize the upper and lower chambers of the heart are also a feature of the new Micra AV2. Additionally, the Micra AV2 has a higher tracking capability for faster heart rates for active patients.
Camille Frazier-Mills, M.D., MHS, an electrophysiologist at Duke University Health System, said “Improved AV synchrony – requiring less in-office reprogramming thanks to algorithm optimization – and longer battery life are major wins for patients.” Camille commented I’m excited to offer my patients the new Micra devices. This best-in-class technology transforms the patient experience by eliminating pocket-related complications, and now reduces the chance that patients will need their device changed in the future.”
According to DelveInsight’s “Pacemakers Market” report, the global pacemakers market was valued at USD 4.88 billion in 2021, growing at a CAGR of 5.85% during the forecast period from 2022 to 2027, to reach USD 6.84 billion by 2027. The demand for pacemakers is primarily motivated due to the rise in cardiovascular diseases (CVDs), superior treatment outcomes of sudden cardiac arrests, and growing technological advancements.
Vivasure Medical Announced Enrolment of First Patient in Pivotal PATCH Study
On May 2, 2023, Vivasure Medical, a company pioneering novel fully absorbable technology for percutaneous vessel closure, announced the enrolment of the first patient in the company’s PerQseal® PATCH Clinical Study, at Kaleida Health’s Buffalo General Medical Center-Gates Vascular Institute in Buffalo, New York by Dr. Vijay Iyer, Chief of Cardiology at the University of Buffalo and Director, Structural Heart Interventions at Buffalo General Hospital.
The PATCH clinical study is a multi-center, single-arm, pivotal study that aims to evaluate the safety and efficacy of the Vivasure PerQseal Closure Device System which is the first suture-less, fully absorbable synthetic implant for large-bore vessel punctures. PerQseal is placed from inside the vessel, which makes the deployment simpler and offers more control than conventional closure techniques.
The trial expects to enroll up to 171 patients across the US and up to 90 patients in up to eight European investigational sites. The data will support a pre-market approval submission to the US Food and Drug Administration (FDA).
PerQseal is meant for addressing the major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation, and abrupt closure among others because of the utilization of suture-or collagen-based closure devices for the closure of large hole arterial access made during percutaneous cardiovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD).
“With the recent proliferation of large bore arterial access, there’s a moment after each procedure when vessel management is critical and clinicians must quickly and effectively close it to reduce unnecessary, potentially life-threatening bleeding,” said Dr. William Gray, system chief in the division of cardiovascular disease at Main Line Health, co-director at the Lankenau Heart Institute in Philadelphia and the principal investigator for the PerQseal PATCH study. William added, “I look forward to evaluating the PerQseal technology and its simplified, controlled technique – with the ultimate goal of reducing vascular complications for these patients.”
According to DelveInsight’s “Vascular Patches Market” report, the global vascular market is estimated to grow at a CAGR of 7.37% during the forecast period from 20232 to 2027. The increase in demand for vascular patches is primarily attributed to the increase in the prevalence of cardiovascular diseases due to genetic factors, age, obesity, unhealthy and sedentary lifestyles, bad eating habits, and an increasing number of geriatric patients prone to vascular diseases, increasing use of vascular patches in surgeries, increased demand of minimally invasive surgeries (MIS), and technological advancements like vascular cell regeneration, cellular integration, and tissue remodeling across the world are anticipated to bolster the market, thereby contributing to the growth of the vascular patches market during the forecast period from 2022-2027.
SunMed Completed the Acquisition of the Respiratory & Anesthesia Consumables Business of Vyaire Medical
On May 1, 2023, SunMed, a leading North American manufacturer and distributor of consumable medical devices for anesthesia and respiratory care, completed the acquisition of Vyaire Medical’s business unit that manufactures and markets respiratory and anesthesia consumables.
By combining, SunMed will create a market leader wholly focused on airway management and surgical care with a more comprehensive offering for practitioners. This company will act as a one-stop shop for the best medical consumables for anesthesia and respiratory care, supporting the best patient outcomes. The acquisition’s terms weren’t made public.
“We are pleased to officially welcome Vyaire’s respiratory and anesthesia consumables team into the SunMed family and are excited by the promising opportunities created by the joining of two great businesses. As we bring our people together, we are confident in the highly complementary nature of our platforms and in our ability to strengthen our manufacturing capabilities and ensure our customer’s reliable and predictable supply of the most trusted respiratory and anesthesia consumables. Together, we will be even better positioned to drive innovation, using our combined expertise and industry-leading engineering capabilities. Our mission will continue to be focused on improving quality of life and setting the standard of care.”Hank Struik, CEO of SunMed
According to DelveInsight’s “Anaesthesia Machines Market” report, the global anesthesia machines market is estimated to advance at a CAGR of 8.2% during the forecast period. 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 Anaesthesia Machines market growth during the forecast period. As per DelveInsigt’s analysis, in the product type segment, the anesthesia delivery machines that not only allow procedures to be performed without pain to the patient but also ensure patient safety throughout, allowing surgeons to achieve the best possible results are expected to hold the major share in the global anesthesia machines market.