Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™

Pi-Cardia Ltd., a prominent player in advancing catheter-based leaflet modification solutions for heart valve treatment, revealed that its ShortCut™ device has attained Breakthrough Device Designation from the US Food and Drug Administration. ShortCut™, recognized as the world’s inaugural device tailored for leaflet modification, is designed to aid valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures for patients susceptible to coronary obstruction. This milestone follows the conclusion of the ShortCut™ Pivotal Study’s enrollment in the US and Europe in September 2023.

“After participating in Pi-Cardia’s extensive clinical program, I am excited to witness the acknowledgment of the significance of ShortCut™,” expressed Dr. Philippe Genereux from Morristown Medical Center in New Jersey. “The lifelong management of aortic stenosis necessitates solutions like ShortCut™ for leaflet modification, ensuring careful consideration of the risk of coronary obstruction before valve implantation. Based on our observations of the procedure’s ease of teaching and execution, it seems that ShortCut™ could be readily embraced by TAVR centers as a crucial pre-implantation step. This would enable the safe treatment of patients at risk of coronary obstruction without disrupting the TAVR workflow.”

ShortCut™ constitutes a segment of Pi-Cardia’s range of products designed to modify leaflets. This assortment encompasses the ShortCut™ Mitral, devised for dividing leaflets in individuals vulnerable to left ventricular outflow tract obstruction after Transcatheter Mitral Valve Replacement (TMVR). Additionally, the portfolio features Leaflex™, an autonomous mechanical scoring device without implantation, aimed at enhancing leaflet mobility and optimizing hemodynamics in patients with aortic stenosis. Presently, global clinical trials for Leaflex™ are in progress.

As per DelveInsight analysis, the Global Transcatheter Aortic Valve Devices market achieved a value of USD 3.23 billion in 2021. It is projected to experience a compound annual growth rate (CAGR) of 15.41% from 2023 to 2028, reaching a valuation of USD 7.64 billion by the end of the forecast period. The escalating prevalence of aortic stenosis disorder, an increase in cardiovascular disorders, a growing demand for transcatheter aortic valve replacement (TAVR) procedures, a rise in cases of aortic regurgitation, and advancements in transcatheter aortic valve replacement technology are key factors propelling the demand for these devices. This surge in demand is expected to contribute significantly to the expansion of the transcatheter aortic valve replacement devices market between 2023 and 2028.

AbSolutions Med, Inc. Receives FDA Breakthrough Device Designation for its REBUILD Bioabsorbable Abdominal Wall Closure Device

AbSolutions Med, Inc., a privately owned company specializing in medical devices, revealed today that the Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to its REBUILD Bioabsorbable abdominal wall closure device. The FDA recognized that REBUILD fulfilled its criteria for Breakthrough Devices, offering a potential innovative solution for the challenging issue of incisional hernia—a condition often characterized by irreversible debilitation. Notably, fewer than 7% of Breakthrough Devices are dedicated to general surgery, highlighting REBUILD as a distinguished product in the medical sector facing challenges in achieving significant progress.

REBUILD aids in securing the closure of the abdominal wall by evenly spreading suture tension across a considerable tissue area. This helps in preserving the alignment of midline fascial structures crucial for healing after surgery. Subsequently, it is absorbed to reduce the potential for enduring complications associated with foreign body presence. Extensive testing in both animal and human studies has yielded encouraging results for REBUILD.

“The realm of hernia repair and prevention has primarily centered around the use of different mesh products. REBUILD adopts a unique perspective by addressing the underlying issue, promoting natural tissue healing to eliminate the presence of foreign bodies in the long term. This approach has the potential to enhance patient quality of life by disrupting the cycle of repairs, complications, and subsequent re-operations, as stated by Dr. Daniel Jacobs, CEO of AbSolutions Med, Inc.“

According to DelveInsight analysis, the global Hernia Repair Devices market achieved a valuation of USD 4 billion in 2021. It is anticipated to experience a CAGR of 5.08% from 2023 to 2028, reaching a projected value of USD 5.38 billion by 2028. The increased need for Hernia Repair Devices is mainly driven by the growing prevalence of hernia, an escalation in hernia treatment surgeries, advancements in product technology, and favorable reimbursement conditions, among other factors.

AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter to Treat Peripheral Arterial Disease

AngioDynamics, Inc. (NASDAQ: ANGO) announced on January 23, 2024, that its Auryon XL Catheter, a 225-cm radial access catheter, has received clearance from the United States Food and Drug Administration (FDA) for utilization alongside the Auryon Atherectomy System in treating Peripheral Arterial Disease (PAD). Employing cutting-edge technology, the Auryon Atherectomy System provides robust treatment for arterial occlusions. As the first laser atherectomy system of its kind, it effectively addresses lesions of any type, length, and location while minimizing impact on vessel walls.

Offering diameters of 0.9 mm and 1.5 mm, the Auryon XL Catheter broadens the scope of access points for atherectomy procedures addressing Peripheral Arterial Disease (PAD). Utilizing a radial access catheter in general may significantly lower the occurrence of major bleeding by over 70%, as compared to femoral access. Moreover, it has the potential to obviate the necessity for femoral closure devices, enabling the treatment of bilateral disease in a single session. This not only enhances patient mobility but also supports quicker discharge and expedited recovery times.

“Since its launch in September 2020, the Auryon Atherectomy System, with its innovative solid-state laser technology, has fundamentally changed patient treatment for PAD and quickly become an essential tool for providers and patients,” said Kimberly Nelson, Senior Director of Auryon Global Marketing at AngioDynamics, Inc. “Our entry into the Radial-to-Peripheral (R2P) space with Auryon XL is an important part of our focus on advancing the quality of care delivery and it demonstrates our commitment to meeting the unmet needs of patients and atherectomy providers.”

“Radial access is more than an entry point; it’s a transformative expressway to enhanced patient outcomes,” said Ankur Lodha, M.D., interventional cardiologist at Cardiovascular Institute of the South located in Lafayette, Louisiana. “With an innovative design and its ease-of-use, the Auryon XL Catheter brings significant advancements to radial procedures as the first non-orbital atherectomy device – setting a new standard for laser atherectomy technology.”

After receiving FDA 510(k) clearance, AngioDynamics commenced a controlled introduction of the Auryon XL Catheter into the U.S. market in January 2024. The company anticipates a complete market release by February 2024.

The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK), and In-Stent Restenosis (ISR) and to date, it has been used to treat more than 50,000 patients in the United States. Clinical studies have demonstrated the efficacy of the Auryon Atherectomy System in treating a spectrum of lesions, from soft plaque to severely calcified. The system incorporates a 355nm wavelength laser platform, facilitating the application of short UV laser pulses with precise biological targeting. This approach proves effective in treating Peripheral Arterial Disease (PAD) while mitigating the risk of perforation and maintaining the capability to vaporize lesions without resorting to thermal ablation.

As per the estimate, Peripheral Artery Disease (PAD) impacts 8.5 million Americans and a staggering 200 million people globally annually. According to DelveInsight, the global market for peripheral artery disease is expected to witness substantial growth by 2032. The increasing incidence of peripheral artery disease, particularly linked to stenosis and arteriosclerosis, is driven by the growing burden of the aging population worldwide. Additionally, the upsurge in risk factors like obesity, diabetes, and high blood pressure, combined with a steady stream of product launches, is fostering a positive market environment. These factors collectively contribute to the overall expansion of the market for peripheral artery disease and stenosis treatment devices in the years ahead.

Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System with AI-Assisted Segmentation and Treatment Planning

Enhatch Inc. announced on January 24, 2024, the successful U.S. Food and Drug Administration (FDA) 510(k) clearance for its patient-specific instrumentation system designed for Total Knee Arthroplasty. This advanced system, distinguished by its AI-driven methodology, revolutionizes total knee arthroplasty by integrating both anatomic model generation and treatment planning. Utilizing Artificial Intelligence (AI) algorithms, the system can transform patient X-rays or CT images into intricate 3D anatomic models, facilitating comprehensive treatment planning and the efficient creation of highly personalized surgical guides.

The adoption of X-ray-based systems for preoperative planning represents a notable leap forward in surgical preparation, providing a reduction in radiation exposure compared to conventional full knee CT scans. This methodology not only minimizes patient exposure to radiation but also plays a pivotal role in constructing precise anatomic models, enabling more accurate and personalized surgical strategies. X-rays are more readily available and extensively reimbursed in the U.S. healthcare system, making this approach operationally efficient and cost-effective. The integration of this technology results in a streamlined process that prioritizes safety, precision, and affordability, benefiting both patients and healthcare providers.

“The recent FDA clearance represents a major company milestone in advancing surgical precision and elevating the standard of patient care. Our Intelligent Surgery Knee software plays a pivotal role in streamlining preoperative planning and crafting patient-specific guides with enhanced efficiency. Leveraging cutting-edge AI technology for accurate modeling of individual anatomies and planning treatments, we are setting new benchmarks within the industry,” commented Michael Phipps, President and CTO of Enhatch, Inc.

“We are excited to launch this new end-to-end patient-specific system designed to seamlessly integrate into surgical practices. Surgeons can effortlessly submit X-ray or CT images, along with treatment details and preferences. Our advanced AI algorithms then go to work to generate precise anatomic models, information for preoperative plans, and surgical guide designs. Planners assess the generated outputs and actively collaborate with surgeons to ensure thorough review and approval of the preoperative plans. By harnessing the power of AI-driven technologies, we aim to optimize surgical workflows for patient-specific surgeries. This commitment aligns with our objective in providing a heightened level of professionalism to patient care,” said Scott Mozeleski, Senior Project R&D Manager, Enhatch, Inc.

As per DelveInsight, the Total Knee Arthroplasty (TKA) market is experiencing robust growth, driven by several key factors. The aging global population, coupled with an increasing prevalence of degenerative joint diseases like osteoarthritis, significantly contributes to the rising demand for knee replacement procedures. Advances in implant technologies and surgical techniques enhance the effectiveness and longevity of TKA, further fueling market expansion.

Moreover, a growing awareness among patients about the benefits of knee replacement, improved healthcare infrastructure, and a surge in healthcare expenditure collectively stimulate the market’s trajectory. Additionally, the continuous innovation in materials, such as bioactive coatings and robotics-assisted surgeries, is propelling the Total Knee Arthroplasty market forward by offering enhanced precision and quicker recovery times.