Integra LifeSciences to Buy Johnson & Johnson’s Acclarent and its ENT Tech

On December 13, 2023, Integra LifeSciences entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent strengthens Integra’s position in the ENT treatment market. Acclarent is a component of J&J MedTech’s Ethicon subsidiary. Integra already sells the ENT instrument MicroFrance series. After the transaction closes, the company thinks it will be in a leadership position offering ENT goods and solutions.

Integra agreed to acquire Acclarent for $275 million in cash at closing. The deal also includes an additional $5 million upon the achievement of regulatory milestones.

“This acquisition presents Integra with a rare opportunity to become a key player in the ENT segment. Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives,” said Jan De Witte, president and CEO of Integra LifeSciences. “We are looking forward to welcoming the Acclarent employees to the Integra team. Together, we can make a profound impact on the future of ENT and neurosurgery.”

Innovative balloon technologies for sinus dilation and eustachian tube dilatation are available in Acclarent’s portfolio. The firm, located in Irvine, California, additionally provides surgical navigation systems. In 2022, its product sales in the US brought in roughly $110 million.

Integra anticipates that the deal will be finalized by 2024’s second quarter. Integra’s Codman Specialty Surgical (CSS) business will welcome Acclarent.

“The ENT segment is an anatomical adjacency to neurosurgery. For example, this acquisition will provide opportunities for ENT and neurosurgeons to closely collaborate on tumor care using skull base approaches,” said Mike McBreen, president of the CSS division. “Acclarent’s strong commercial capabilities, R&D expertise, advanced portfolio and deep clinical knowledge will be important assets to Integra, allowing us to deliver future innovation not only within ENT, but also across our other CSS technology platforms.”

As per DelveInsight’s “Sinus Dilation Devices Market” report, the global Sinus Dilation Devices market was valued at USD 1.52 billion in 2021, growing at a CAGR of 9.10% during the forecast period from 2023 to 2028, to reach USD 2.55 billion by 2028. The rise in demand for Sinus Dilation Devices is primarily attributed to the growing burden of rhinosinusitis both acute and chronic among the worldwide population. Moreover, the rising preference for the minimally invasive procedures and benefit of balloon sinuplasty over conventional treatment methods is also expected to surge the market for Sinus Dilation Devices. Also, increasing technological advancement and the presence of several reimbursement policies and initiatives concerned with the treatment of sinusitis, among others, are the factors responsible for the global Sinus Dilation Devices market growth. The report covers the Sinus Dilation Devices Market By Product Type (Balloon Sinuplasty Devices, Sinus Implants/Stents, Functional Endoscopic Sinus Surgery Instruments Set, Others), By End-User (Hospitals, Ent Clinics, And Others), by geography, is expected to expand at a static CAGR forecast till 2028 due to the growing prevalence of chronic rhinosinusitis across the globe and increasing preferences for minimally invasive surgeries such as balloon sinuplasty among the population. 

Medtronic Creates History With FDA Approval of its Novel PulseSelect Pulsed Field Ablation System to Treat Atrial Fibrillation

On December 13, 2023, Medtronic plc announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November.

“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency1.  It’s a major step towards fulfilling our vision of providing disruptive electrophysiology solutions for patients,” said Rebecca Seidel, SVP and President of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. “The PulseSelect PFA system, together with the CE Marked Affera™ mapping and ablation system and our strong Cryo platform, enables us to provide a broad portfolio of solutions to clinicians and their patients, all developed with years of research and supported by compelling scientific evidence.”

Through consistent and predictable energy supply and catheter flexibility, the PulseSelect PFA system offers quick and efficient pulmonary vein isolation (PVI). It was designed with unique safety features. A clinician’s chosen workflow can seamlessly migrate to PFA thanks to the system’s design. The PULSED AF research, which demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AF patients, provides evidence for the safety, effectiveness, and efficiency of the PulseSelect PFA system.

“The PulseSelect PFA system ushers the EP community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice,” said Dr. Amin Al-Ahmad, clinical cardiac electrophysiologist at St. David’s Medical Center in Austin, TX and one of 67 global operators in the PULSED AF trial. “In my clinical experience with the catheter, it was designed for AF ablation procedures. The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation.”

The PulseSelect PFA system also includes the following:

  • Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with just fluoroscopy2.
  • Built-in safety features such as a phrenic nerve test pulse, a non-therapeutic low voltage pulse that provides a preemptive assessment of catheter proximity to the phrenic nerve prior to delivering a therapeutic application.
  • Fixed spacing for the nine-electrode catheter, which produces a predictable and consistent electric field for contiguous ablation2. In addition to ablation, the nine electrodes can also be used for pacing and sensing.
  • The small, 9Fr bidirectional catheter enhances maneuverability and access to various anatomical structures and is compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour™ sheath.

“We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the U.S.,” said Khaldoun Tarakji, MD MPH, Chief Medical Officer of the Cardiac Ablation Solutions business at Medtronic. “Every patient deserves the best care. What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients’ needs.”

Additionally, the PulseSelect PFA system is the first PFA technology to be authorized by the FDA with a Breakthrough designation. The designation is meant to facilitate faster patient access to medical devices that could significantly improve the diagnosis or treatment of life-threatening illnesses. The PulseSelect PFA system will go on sale in the first part of 2024.

According to DelveInsight’s “Ablation Devices Market” report, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2023 to 2028. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmia such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028. 

B. Braun Launches the CARESITE Micro Luer Access Device and Extension Sets 

On December 6, 2023, B. Braun Medical Inc. announced the launch of its new CARESITE Micro Luer Access Device, designed to reduce exposure to harmful chemicals and decrease infection risk, making IV access safer for patients and healthcare providers. 

The only needleless connector that isn’t produced with Bisphenol A (BPA), a dangerous substance that can be damaging to multiple organs, is the CARESITE Micro Device. The CARESITE Micro Device, which is composed of a material that is resistant to drugs, can lessen the possibility of drug exposure and infections due to stress cracks brought on by incompatibilities between the material and the medicine.

A leading cause of morbidity and death is still hospital-acquired bloodstream infections (HA-BSIs), which are frequently connected to catheter insertions. In order to minimize the danger of HA-BSI, the CARESITE Micro Device has a smooth, flat surface that enables adequate disinfection and a straight fluid route design that aids in the thorough flushing of blood and drugs with a modest flush volume.

“We are excited to introduce the CARESITE Micro Luer Access Device. Helping to reduce HA-BSIs and accidental drug exposure supports our commitment to the safety of the patients and providers we serve,” said Angela Karpf, MD, Corporate Vice President, and Medical Affairs.

According to DelveInsight’s “Needle-Free Injections Market” report, he global needle-free injection systems market was valued at USD 12.49 billion in 2022, growing at a CAGR of 14.16% during the forecast period from 2023 to 2028 to reach USD 27.65 billion by 2028. The demand for needle-free injection systems is witnessing growth due to the rising prevalence of chronic diseases, expanding number of needle-stick injuries, increasing requirement of self-injection devices, growing number of vaccination programs, and technological innovation in product development, among other factors.

Sight Sciences Touts Positive Six-Month Results For Heat Therapy Device 

On December 19, 2023, Sight Sciences revealed further positive results from its SAHARA trial investigating TearCare technology for the treatment of dry eye disease.

Published in Clinical Ophthalmology, the six-month results show that the company’s heat therapy device, TearCare, is superior to Allergan (AbbVie)’s Restasis eyedrops (cyclosporine ophthalmic emulsion). The usual course of treatment for dry eye illness is restasis. In the first phase of the Phase I trial (NCT04795752), US-based Sight Sciences compared twice-daily administration of the eyedrops to TearCare procedures, and a follow-up at five months. Patients who did not respond well enough were given a further nine months.

Tear break-up time, the trial’s primary outcome, improved by 2.4 seconds with TearCare. When it came to the trial’s other main outcome, patient-reported outcomes as measured by Ocular Surface Disease Index (OSDI) scores, TearCare and Restasis both showed similar improvements. The Phase I data was first presented in October 2023, and the results come after that.

The main cause of dry eye disease is failure of the meibomian glands, which results in a disruption of the lipid layer in the tear film. According to Sight Sciences, TearCare outperformed the other two functional tests for the meibomian gland secretion score, the number of glands producing any liquid, and the number of glands producing clear liquid.

Both TearCare and Restasis demonstrated comparable improvements in measures of corneal and conjunctival health measures, as well as patient-reported outcome measures. The prospective, randomised, masked, controlled trial enrolled 350 patients with dry eye disease. Each therapy session lasted 15 minutes.

The TearCare system, which was cleared by the US Food and Drug Administration in December 2021, uses localised heat therapy via non-surgically affixed electrothermal devices. The procedure is used in conjunction with manual expression of the meibomian glands by blinking.

The SAHARA trial’s Restasis cohort will have an interventional TearCare procedure and be followed up on for an additional six months. For a further 18 months, the TearCare cohort will undergo additional procedures to assess the treatment’s durability. According to SightSciences, the one-year crossover data should be accessible by the end of the next year.

According to DelveInsight’s “Artificial Tears Market” report, the global artificial tears market is estimated to grow at a CAGR of 5.1% during the forecast period from 2023 to 2028. The demand for artificial tears is primarily being boosted by the increasing figures of dry eye syndrome due to prolonged exposure to chronic conjunctivitis, regular air travel, digital layouts, poor eyelid, scars of eye injury, poor diet, malnutrition, the surge in level of pollution, dry weather spells, and drastic climatic changes. Further, the increasing demand for preservative-free artificial tears, the growing requirement for advanced care for post-surgery dry eyes, technological advances, the mounting number of mobile and smartphone addicts, the escalating number of people wearing contact lenses, and the increasing product launches and approval among others are thereby contributing to the overall growth of the artificial tears market during the forecast period from 2023-2028.

Perfuze Announces FDA Clearances for Novel Neurovascular Aspiration and Access Catheters for Stroke Treatment 

On December 20, 2023, Perfuze announced FDA clearance for the Millipede 070 Aspiration Catheter and the 2nd generation of the Millipede 088 Access Catheter. 

The groundwork for the innovative and unique technology behind the Millipede 070 Aspiration Catheter allows doctors to treat patients with ischemic strokes and meet important unmet needs. Its purpose is to remove clots quickly and securely. This new and innovative catheter offers a more sophisticated method of reestablishing blood flow to the brain during endovascular thrombectomy treatments. It is engineered for exceptional deliverability and excellent procedural efficiency.

“In our initial experience with Millipede 070, the system easily delivered to the target occlusion allowing rapid, effective and safe reperfusion,” stated David Fiorella, Director of the Stony Brook Cerebrovascular Center, NY, USA. Millipede 070 has a unique design with a rib-and-recess surface architecture designed to improve navigability and reduce tip stiffness, while maintaining durability.

“Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, CEO of Perfuze. “The 510(k) clearance for the Millipede 070 Aspiration Catheter is a key addition to our portfolio of products and is designed to simplify removal of the clot and improve clinical outcomes.”

The Millipede 070 Aspiration Catheter is one of the expanding range of endovascular interventional devices from Perfuze that are intended to enhance and optimize stroke therapy. Patients are being enrolled by the business for the pivotal clinical study MARRS, which will help with the Millipede System’s regulatory applications.

Furthermore, Perfuze’s second-generation Millipede 088 Access Catheter was cleared for 510k use. The purpose of this catheter is to make it easier to insert and guide microcatheters safely during neurointerventional or diagnostic operations. The U.S. FDA granted 510(k) clearance for the Millipede 088 Access Catheter in 2022. Perfuze works to improve all facets of stroke treatment, from vessel access to thrombectomy, using a physician-led approach to device innovation. These 510(k) approvals represent a significant accomplishment for the business and demonstrate its dedication to consistently improving neurovascular treatment.

About 16 million individuals worldwide are affected by strokes each year, which is thought to be the cause of 6 million fatalities. Every year, acute ischemic stroke affects around 1.5 million people in the US and Europe, costing the healthcare systems more than $100 billion. Stroke is a highly time-sensitive illness, and most patients die or become permanently disabled if they do not receive the proper diagnosis and care. Merely 10% of eligible stroke patients currently undergo thrombectomy treatment, despite recent advancements in life-saving endovascular treatment. 

According to DelveInsight’s “Diagnostic Catheters Market” report, the global diagnostic catheter market was valued at USD 4,497.47 million, growing at a CAGR of 6.65% during the forecast period from 2023 to 2028 to reach USD 6,601.68 million by 2028. The diagnostic catheter market is observing remarkable market growth due to the factors such as the growing prevalence of various chronic disorders such as cardiovascular, neurological, and urological, among others. Furthermore, the rising demand for imaging devices in disease diagnosis, growing technological developments in the imaging catheter, an increasing number of imaging and diagnostic centers, an increasing product launch and approvals, and the presence of key players in the market, among other factors will create a requisite for the diagnostic catheters market. Therefore, the market for diagnostic catheters is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

ShiraTronics Successfully Implants First Migraine System

On December 20, 2023, ShiraTronics has successfully implanted its Chronic Migraine System in six patients, a significant advancement in migraine treatment, marking a major step forward in the field of neuromodulation.

The implantation is a component of the clinical study RELIEV-CM, which is being conducted in conjunction with Australian researchers. A group of neurologists and specialists in pain management are in charge of supervising and gathering data for this investigation. It serves as a performance evaluation tool for the ShiraTronics Chronic Migraine System and establishes the framework for further study.

The fully implantable system has been designed for the head using a minimally invasive technique and is aimed at chronic migraine management. 

ShiraTronics CEO Rob Binney said: “The achievement of this crucial milestone has validated all aspects of our procedure, system, and therapy settings. Notably, it is encouraging that all six patients who completed the trial procedure opted for the permanent implantation of the ShiraTronics system.”

In order to interfere with migraine pain impulses, the technology delivers precise electrical pulses. This fully implantable, programmable gadget offers patients and doctors a potentially novel approach to treatment.

Australian clinical research organisation Cercare director Dr Matthew Green implanted the ShiraTronics Chronic Migraine System in the patients.

Green said: “With two successful implants completed at our centre, we are highly encouraged by the results. This technology introduces a new therapy option previously unavailable to patients and offers great hope where previously there was none for those grappling with chronic migraine.”

About 2% of people have chronic migraines, which impair the quality of life for sufferers by causing excruciating headaches and other severe symptoms for at least 15 days every month. The fact that many current treatments are insufficient emphasizes the need for novel therapeutic approaches. The technology from ShiraTronics is designed especially to counteract the crippling effects of persistent migraines.

According to DelveInsight’s “Neuromodulation Devices Market” report, the global neuromodulation devices market was valued at USD 5.71 billion in 2022, growing at a CAGR of 8.95% during the forecast period from 2023 to 2028, to reach USD 9.56 billion by 2028. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target applications, technological advancement in the product portfolio, rising government initiatives to raise awareness among patient regarding neurological disorders, among others.