“This approval strengthens our broader initiative to provide physicians with LBBA-specific tools and educational resources, while reinforcing our commitment to developing safe and effective pacing technologies,” said Scott Olson, senior vice president and president, Cardiac Rhythm Management and Diagnostics, Boston Scientific. “We believe the expanded indication for the INGEVITY+ Pacing Lead will enhance the implant experience for physicians and connect this technology to the growing number of patients who can benefit from LBBA pacing.”
“This expanded indication provides physicians using the INGEVITY+ Pacing Lead the flexibility to determine the most appropriate pacing strategy based on individual patient characteristics,” said Kenneth Stein, M.D., Senior Vice President and Global Chief Medical Officer, Boston Scientific. “Data has demonstrated this lead to be safe and effective for LBBA pacing – a rapidly growing pacing technique – allowing us to provide a new therapeutic option on a proven lead that will further the quality of patient care.”
The FDA was provided with clinical evidence to support the expanded indication, which included data from about 400 patients in the INSIGHT-LBBA study, where INGEVITY+ pacing leads had been previously implanted in the LBBA for anti-bradycardia pacing, along with results from bench testing and LATITUDE™ Programming System data.
During its implantation, the INGEVITY+ Pacing Lead was guided by a stylet, allowing for optimal positioning within the heart and ensuring continuous pacing along with impedance monitoring for secure placement. The expanded indication was granted after the release of Boston Scientific’s CSP portfolio, which included tools such as the OneLINK™ Splitter Cable, INGEVITY+ Helix Locking Tool, and pacing delivery catheters, all aimed at supporting the safe implantation of the INGEVITY+ lead in the LBBA. The lead had initially received FDA approval in 2019 for use with pacemakers and defibrillators.
As per DelveInsight’s “Pacemakers Market Report”, the global pacemakers market was valued at USD 4.88 billion in 2023, growing at a CAGR of 5.85% during the forecast period from 2024 to 2030, to reach USD 6.84 billion by 2030. 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 among others during the forecast period.
Philips Received FDA Approval For Its Advanced LumiGuide Guidewire and Marked The Occasion by Treating Its 1000th Patient With The Breakthrough 3D Device Guidance Technology
On September 17, 2024, Royal Philips, a global leader in health technology, announced the FDA approval and launch of the 160cm version of its LumiGuide endovascular navigation wire. The enhanced LumiGuide guidewire, which incorporated the company’s groundbreaking Fiber Optic RealShape (FORS) technology, was first utilized by Professor Carlos Timaran, MD, an internationally recognized vascular surgeon. The procedure, involved a complex aortic aneurysm repair, and marked the 1000th patient treated with FORS technology since its initial clinical use in 2020. This new, longer FORS-enabled LumiGuide Navigation Wire had provided US clinicians with the capability to visualize a broader range of catheters, thereby extending the technology’s application to more patients across American centers.
“The new enhanced Philips LumiGuide navigation guidewire represents a significant leap forward in endovascular surgery, offering unprecedented 3D visualization and precision during complex procedures, as the first to use this guidewire for a complex aortic repair, I experienced firsthand its potential to revolutionize how we approach minimally invasive vascular interventions. The patient who underwent this groundbreaking procedure is doing well, further validating the efficacy of this innovative technology.” said Carlos Timaran, MD, an internationally recognized expert in advanced endovascular techniques.
“LumiGuide unlocks the color visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically unachievable using conventional C-arm systems, it has already been shown to improve workflows, reduce procedure times, and decrease patient and staff radiation dose,” said Dr. Atul Gupta, Chief Medical Officer for Diagnosis and Treatment at Philips and a practicing interventional radiologist.
Traditionally, minimally-invasive surgeries typically required doctors to use live X-ray imaging (fluoroscopy) to guide interventional devices like catheters inside patients. This method presented radiation risks for both patients and physicians and only delivered grayscale, 2D images. The LumiGuide system, powered by Philips’ FORS technology, had transformed this practice by providing real-time, 3D, color images of guidewires and catheters from any angle with minimal radiation exposure. Philips’ FORS technology had eased navigation through tortuous vessels, allowing complex aortic repair procedures to be performed 37% faster and using 70% less X-ray imaging. The introduction of the 160cm LumiGuide wire had enhanced reach and catheter loading capabilities compared to the 120cm guidewire, enabling US physicians to utilize 3D device guidance with a greater variety of catheters and extending the technology’s use to more patients and procedures.
As per DelveInsight’s “Coronary Guidewires Market Report”, the global coronary guidewire market is estimated to grow at a CAGR of 5.7% during the forecast period from 2024 to 2030. The demand for coronary guidewire is primarily being boosted due to the increasing prevalence of coronary artery disease (CAD) across the globe. Further, the rising adoption of advanced and innovative technologies, the rising awareness about minimally invasive heart surgeries, the increasing geriatric population prone to various cardiovascular diseases, rising figures of various risk factors causing coronary heart diseases, and the increasing product launches and approval among others, are thereby contributing to the overall growth of the coronary guidewire market during the forecast period from 2024 to 2030.
Microbot Medical Announced The Successful Enrollment of 50% of The Patients in Its Pivotal Human Clinical Trial For The LIBERTY Endovascular Robotic Surgical System
On September 17, 2024, Microbot Medical Inc., the developer of the LIBERTY® Endovascular Robotic Surgical System, announced that it successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial. The company had enrolled and completed follow-up for 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The company had anticipated completing enrollment and follow-up in the fourth quarter of 2024 and filing its 510(k) submission with the U.S. Food and Drug Administration (FDA) by the end of 2024.
ACCESS-PVI is a prospective, multi-center, single-arm, clinical trial designed to evaluate the performance and safety of LIBERTY® in human subjects undergoing Peripheral Vascular Interventions. The trial is expected to support the future 510(k) submission to the FDA and, when approved, subsequent commercialization.
“I have performed several procedures using LIBERTY® during the trial and I am continuing to enroll patients,” commented Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology) at Brigham and Women’s Hospital in Boston. “I am pleased with the ease of use and quick set-up of the robot, requiring, in my experience, a very short learning curve.”
“We are excited by both the achievement of this milestone, and physician feedback. We remain on track to complete the trial and subsequent submission of the 510(k) to the FDA before year end,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer.
The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.
According to DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
Innovent Delivered Oral Presentations on The Clinical Data of IBI354 in Advanced Ovarian Cancer, Breast Cancer, and Other Solid Tumors at the 2024 ESMO Congress
On September 18, 2024, Innovent Biologics, Inc., known for its development, manufacturing, and commercialization of high-quality treatments for various serious diseases, revealed that the clinical data for IBI354 (HER2 monoclonal antibody-camptothecin derivative conjugate) in advanced solid tumors was showcased at the 2024 ESMO Congress.
The data presented was from a Phase 1/2 study designed to assess the safety, tolerability, and preliminary efficacy of IBI354 in patients with advanced solid tumors. A total of 368 participants were enrolled in the study, receiving various doses of IBI354 monotherapy. This cohort included 178 individuals with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other types of tumors. Of these participants, 42.7% had previously undergone five or more systemic treatment regimens.
IBI354 monotherapy demonstrated an excellent safety profile. The dosage was escalated to 18mg without any dose-limiting toxicity (DLT) events observed. The most common treatment-related adverse events (TRAEs) were nausea, decreased white blood cell count, and anemia. Interstitial lung disease (ILD) occurred in only 1.6% of patients, all at grade 1 severity. Overall, 21.5% of patients experienced TRAEs of grade 3 or higher, 2.4% had TRAEs that led to dose reduction, and 1.6% experienced TRAEs that resulted in discontinuation. No TRAEs led to death.
Doctor Daphne Day from the Medical Oncology Department at Monash Health in Melbourne, Australia, stated, “Breast cancer is the second most commonly diagnosed cancer globally, the most common cancer in women, and a cause of cancer-related deaths. HER2 amplification or overexpression has been proven to play a significant role in the occurrence and progression of breast cancer, underscoring the importance of HER2-directed therapy. IBI354, as an anti-HER2 monoclonal antibody-camptothecin derivative conjugate, has shown promising preliminary results, with meaningful objective response and disease control rates in HER2-positive and -low breast cancer. Additionally, IBI354 has demonstrated excellent clinical safety and tolerability. Existing clinical data suggest that IBI354 has substantial development potential in the breast cancer population.”
According to DelveInsight’s “Cancer Monoclonal Antibodies Market Report”, the cancer monoclonal antibodies market was valued at USD 80.59 billion in 2023, growing at a CAGR of 10% during the forecast period from 2024 to 2030 to reach USD 156.59 billion by 2030. The demand for cancer monoclonal antibodies is primarily being boosted owing to the rising cases of cancers, the growing number of risk factors for cancers such as smoking, exposure to radiation, faulty lifestyle, and others, rising research and developmental activities by market players, during the forecast period from 2024 to 2030.
Boston Scientific Closed Acquisition of Silk Road Medical, Inc.
On September 17, 2024, Boston Scientific Corporation announced the completion of its acquisition of Silk Road Medical, Inc., a medical device company known for pioneering a new approach to stroke prevention and treating carotid artery disease through a minimally invasive procedure called transcarotid artery revascularization (TCAR).
“Completing this acquisition enables Boston Scientific to strengthen our vascular technology solutions by bringing the innovative TCAR platform to a greater number of physicians and their patients through our significant commercial reach,” said Cat Jennings, president, Vascular, Peripheral Interventions, Boston Scientific. “The integration of the TCAR platform into our portfolio means we can offer a treatment option for patients suffering from carotid artery disease that can reduce the risk of stroke and lead to improved patient outcomes.”
The acquisition included a purchase price of $27.50 per share, resulting in an enterprise value of approximately $1.18 billion. The impact on Boston Scientific’s adjusted earnings per share was expected to be immaterial in 2024 and 2025, with a positive effect anticipated thereafter. However, the impact on GAAP earnings per share was projected to be less accretive or potentially dilutive, due to amortization expenses and acquisition-related net charges.
According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market Report”, the global MIS devices market was valued at USD 28,873.25 million in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030, to reach USD 42,499 million by 2030. The MIS devices market is witnessing positive market growth owing to factors such as the rising prevalence of various cancers such as lung cancer which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2023, and other indications such as cardiovascular diseases, and neurodegenerative diseases among others. Furthermore, the presence of factors such as growth in the aging population wherein age plays a key role in the development of various indications is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development such as the development of surgical robots are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.
Argon Medical Launched CLEANER Vac™ Thrombectomy System to Remove Blood Clot in The Peripheral Venous Vasculature
On September 16, 2024, Argon Medical Devices, a prominent provider of medical device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announced the launch of the CLEANER Vac™ Thrombectomy System. This new system was designed for the removal of blood clots from the peripheral venous vasculature.
The CLEANER Vac Thrombectomy System is a disposable, large-bore aspiration system designed to quickly and effectively remove blood clots, also known as thrombus, from vessels with restricted blood flow. The device empowers physicians to manually control powered aspiration, enabling procedures with precise clot removal that may minimize vessel damage and reduce blood loss.
“Removing thrombus from the venous anatomy can be very challenging depending on the patient’s condition. Interventionalists need a simple and intuitive tool that allows them to easily navigate through the vasculature to the treatment area and control the removal of any obstructive thrombus. The streamlined design of the CLEANER Vac enables easy assembly, quick navigation, and efficient treatment, making it a welcomed treatment option for patients with this disease state.” said Fakhir Elmasri, Interventional Radiologist, Lakeland Vascular Institute in Lakeland. Fl. Dr. Elmasri was the first physician in the United States to treat a patient with the CLEANER Vac Thrombectomy System.
“We are committed to advancing healthcare and we are excited to deliver the newest thrombectomy solution to interventionalists who prioritize efficient, successful outcomes for their patients. The CLEANER Vac Thrombectomy System is a testament to our dedication to improving treatment for this disease state, and we are confident this device will easily integrate into the current standard of care,” said George Leondis, President & CEO, Argon Medical.
“Nearly 900,000 people in the United States are diagnosed with problematic blood clots in the venous system, every year, leading to between 60,000 and 100,000 deaths annually1. The CLEANER Vac Thrombectomy System offers physicians more control to remove those clots and the streamlined design can simplify traditionally complex procedures,” said Tom Younker, Senior Vice President of Global Marketing, Argon Medical.
According to DelveInsight’s “Peripheral Vascular Devices Market Report”, the global peripheral vascular devices market size was valued at USD 9 billion in 2023, and it is expected to continue growing at a CAGR of 7.88% from 2024 to 2030. The demand for peripheral vascular devices is witnessing a surge due to rising prevalence of peripheral vascular diseases (PVDs), including peripheral artery disease (PAD) and deep vein thrombosis (DVT), due to aging populations and increasing rates of diabetes and hypertension, technological advancements in device design, such as the development of minimally invasive techniques, increasing awareness and diagnosis of vascular conditions lead to higher treatment rates and ultimately contributing in the overall growth of the peripheral vascular devices market during the forecast period from 2024 to 2030.
