Ergo-Series of the OMNI® Surgical System Launched by Sight Sciences

On March 9, 2023, Sight Sciences, Inc., an eyecare technology company focused on developing and commercializing innovative technology, providing solutions for transforming care and improving patients’ lives, announced the launch of the Ergo-Series of the OMNI® Surgical System in the United States. 

The OMNI® Surgical System facilitates surgeons to perform implant-free glaucoma, through a minimally invasive procedure in adults with primary open-angle glaucoma. It enables minimally invasive glaucoma surgery (MIGS) that addresses the trabecular meshwork, Schlemm’s canal, and collector channels—the three known points of resistance in the aqueous outflow system. It can be applied before, concurrently with, or after cataract surgery. Some of the new features of the OMNI® Surgical System are as follows:

  • Improved Handle Ergonomics: With new improvements, surgeons are now better able to precisely rotate and position the cannula tip within Schlemm’s canal using their fingers as opposed to their wrists.
  • Simplified Viscoelastic Preparation: The viscoelastic luer connector on the handle is now detachable and separates when the viscoelastic cartridge is removed, giving the surgical microscope more clearance.
  • New Cannula Tip Design: The Ergo-Series cannula tip has a new profile that permits gentle and accurate access to Schlemm’s canal while maintaining the ability to perform the full 360-degree catheterization necessary for the OMNI procedure.

“For me, the new cannula tip technology is the biggest improvement. The profile of the tip enables me to score the trabecular meshwork more confidently and makes entry into Schlemm’s canal gentler. In addition, when I deploy the catheter, I can follow the path of Schlemm’s canal a bit more naturally. In our glaucoma surgery practice, access to the OMNI Surgical System lets us provide these new technology procedures for the benefit of our patients”

Zarmeena Vendal, MD, glaucoma surgeon and founder of Westlake Eye Specialists in Austin, Texas.

“OMNI is an innovative technology developed to enable a surgeon to perform a circumferential and complete outflow procedure that addresses all three known points of resistance in the aqueous outflow system through a single clear corneal incision. We are committed to continually innovating and improving our core technologies alongside our surgeon partners to provide the greatest benefit to patients suffering from primary open-angle glaucoma. Based on the initial feedback, we are confident the Ergo-Series of the OMNI Surgical System will continue to raise the bar.”

Paul Badawi, CEO and co-founder of Sight Sciences, said,

As per DelveInsight’s “Glaucoma Drainage Devices Market” report, the global glaucoma drainage devices market was valued at USD 640.57 million in 2021, growing at a CAGR of 11.95% during the forecast period from 2022 to 2027, to reach USD 1,184.39 million by 2027. The increase in demand for glaucoma drainage devices is primarily due to the rising prevalence of glaucoma across the globe, increasing lifestyle disorders such as diabetes and hypertension, the growing burden of the old age population, and technical innovation in product development are expected to boost the market for glaucoma drainage devices during the forecast period.

LivaNova Received US FDA 510(k) Clearance for Essenz Heart-Lung Machine for Cardiopulmonary Bypass Procedures

On March 9, 2023, LivaNova PLC, a market-leading medical technology and innovation company, announced that it has received the US Food and Drug Administration (FDA) 510(k) clearance for its Essenz™ Heart-Lung Machine (HLM).

The Essenz™ Perfusion System, which is made up of the Essenz HLM and Essenz™ Patient Monitor, enables a patient-tailored perfusion approach built on data-driven decisions that enhance clinical workflows and patient care quality during cardiopulmonary bypass (CPB) procedures.

Key characteristics of the Essenz Perfusion System include:

  • Safety and Reliability: The LivaNova S5™ HLM, which has supported millions of patients for secure CPB procedures, is the foundation upon which the system is built. On Essenz, each pump is individually controlled for easy, uncomplicated operation. Before the CPB procedure begins, HLM sensor checks confirm readiness. To further guarantee dependability, the Essenz HLM cockpit and Essenz Patient Monitor are connected but run independently.
  • Patient-Tailored Care: The Essenz Patient Monitor’s precise sensing technology and user-friendly dashboard provide essential information to support individualized, data-driven patient care throughout a case. To assist perfusionists in implementing goal-directed perfusion (GDP), a treatment that effectively lowers the risk of acute kidney injury, Essenz Patient Monitor makes use of official formulas. Mast-mounted pumps let the user position the disposables (such as the oxygenator and perfusion tubing set) in the best possible way, minimizing priming volumes and lowering hemodilution.
  • Intuitive: To help the perfusionist throughout a procedure, the Essenz Patient Monitor offers an intuitive user interface and continuously records and displays data and events. Data is transferred automatically and seamlessly, reducing the need for manual data entry and giving the perfusionist in the OR more time. The technology platform is a wise long-term investment because it is designed to support a steady stream of future software features and functionalities.
  • Flexible and efficient: The Essenz Perfusion System can be customized to meet the unique requirements of adult and pediatric patients, as well as user workflows and user groups. It has a sleek, hygienic design with advanced cable management, a mast-mounted construction, and ergonomic features to reduce distractions. The novel cockpit offers a centralized view from which to control the apparatus and monitor all perfusion and patient parameters. Additionally, Essenz has seamless integration with hospital information systems and external OR devices.

LivaNova began the commercial launch of Essenz in the United States after receiving FDA approval. Additionally, the company has the approval of the Japanese Pharmaceuticals and Medical Devices Agency and Health Canada for their Essenz HLM (PMDA). Following a successful limited commercial release that helped more than 200 adults, pediatrics, and neonatal patients in Europe, LivaNova also started a broad commercial release there.

“The Essenz Perfusion System has tremendous potential to become a key addition to our clinical practice, fusing a new era of technology with the skill and expertise of the perfusionist. Since we participated in the Essenz HLM validations and the early release of the Essenz Patient Monitor, we’ve witnessed the System’s immense ability to unlock the potential of individualized care throughout all phases of CPB procedures,”

Larry Garrison, Chief Perfusionist at Franciscan Health Indianapolis in Indianapolis, Indiana.

“A perfusion system acts as a patient’s heart and lungs during an open-heart procedure, so having the highest-quality system backed by the expertise of a skilled perfusionist is paramount. When we were designing Essenz, perfusionists told us they needed a system that gives them access to comprehensive data to drive more informed decision-making throughout the entire procedure. We’ve done that with Essenz. Through next-generation hardware and software, Essenz empowers perfusionists to better serve their patients with increasingly tailored care.”

Damien McDonald, Chief Executive Officer of LivaNova

According to DelveInsight’s “Cardiopulmonary Bypass Equipment Market” report, the global cardiopulmonary bypass equipment market was valued at USD 405.18 million in 2021, growing at a CAGR of 4.14% during the forecast period from 2022 to 2027, to reach USD 516.82 million by 2027. The demand for cardiopulmonary bypass equipment is primarily motivated by the increase in the prevalence of cardiovascular diseases like atrial fibrillation, atrial flutter, and supraventricular tachycardia, decrease in heart muscle elasticity, decrease in heart output, rising burden of cardiovascular diseases, and rising geriatric population during the forecast period. 

Occlutech Announced First Patient Enrolment in the US Pivotal Study for Atrial Flow Regulator (FROST-HF)

On March 13, 2023, Occlutech Holding AG, one of the world’s leading providers of minimally invasive structural heart disease devices, announced the first patient enrolment in the FROST-HF study, investigating Occlutech’s Atrial Flow Regulator (“AFR”) in the treatment of patients with heart failure with either preserved ejection fraction (“HFpEF”) or reduced ejection fraction (“HFrEF”). 

This investigation is randomized, double-blinded, multi-center, and sham-controlled, enabling Occlutech to gather information on the security and efficiency of the AFR device in patients. The information will help in a marketing application for US commercial use to the US Food & Drug Administration. In the US, Canada, and Europe, 588 patients and an additional roll-in cohort of 110 patients will be randomly assigned for the FROST-HF Investigational Device Exemption study.

With its Atrial Flow Regulator therapy, Occlutech hopes to improve the lives of the several hundred thousand patients who suffer from this debilitating condition each year. For a growing number of patients for whom there are few available treatments, the AFR has the potential to save lives and enhance the quality of life. 

“Inter-atrial shunt devices represent an important promise for heart failure patients who remain symptomatic despite medications. At Lenox Hill Hospital we are proud to be participating in this clinical trial, offering our patients cutting-edge technology for the potential treatment of this serious condition. We look forward to continuing our collaboration for the advancement of the field”.

Dr. Miquel Alvarez, Principal Investigator at Lenox Hill Hospital

“In this regard, The FROST-HF trial is the most comprehensive trial comparing inter-atrial shunting to the latest guideline-directed therapies across the broad heart failure phenotype with the potential to impact on advancing the existing standard of care,”

Prof. Dr. Stefan Anker, FROST-HF executive committee co-chair, and professor at the German Heart Center of Charité University Medicine Berlin.

According to DelveInsight’s “Congestive Heart Failure Treatment Devices Market” report, the global congestive heart failure treatment devices market was valued at USD 17.41 billion in 2021, growing at a CAGR of 8.26% during the forecast period from 2022 to 2027 to reach USD 27.96 billion by 2027. The congestive heart failure (CHF) treatment devices market is witnessing positive growth owing to the rising incidence of cardiovascular diseases (CVDs), a surge in research and development activities, and increasing incidences of the aging population who are susceptible to these diseases. 

Moreover, the sedentary lifestyle and extreme benefits of these devices in heart failure cases during the COVID-19 pandemic and the growing popularity of minimally invasive interventions had further pushed the demand for these devices, thereby contributing to the growth of congestive heart failure (CHF) treatment devices market during the forecast period from 2022-2027. 

HeartBeam Announced the Acquisition of LIVMOR Assets 

On March 14, 2023, HeartBeam, Inc., a cardiac technology company that developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection, announced the strategic acquisition of substantially all assets from LIVMOR, a digital health solutions company providing a patient-engaging remote monitoring system of critical physiological biomarkers. The acquisition expands HeartBeam’s reach in remote monitoring and detection with full control over an existing cutting-edge FDA-cleared product.

According to the acquisition agreement, HeartBeam paid an undisclosed sum for LIVMOR’s intellectual property, which included three United States patents that had been granted, LIVMOR technology, such as the Halo AF Detection System, business contracts and relationships, and all of the company’s stock of Samsung watches and tablets. HeartBeam also hired key technical personnel from LIVMOR.

LIVMOR, which was founded in 2016, created the Halo+™ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. The Halo system continuously monitors pulse rhythms to detect AF on-demand during the day and automatically overnight. LIVMOR’s technology has been commercially deployed within the Dallas VA Healthcare System.

In addition, to connect doctors and patients, HeartBeam and LIVMOR partnered in February 2022 to create a HeartBeam-branded version of the FDA-cleared Halo cloud-based software platform. HeartBeam was able to meet its deadline for FDA submission of the HeartBeam AIMI™ software for acute care settings, which offers a 3D vector electrogram (VECG) comparison of baseline and symptomatic 12-lead ECG to more precisely identify a heart attack. This was made possible by using the Halo cloud-based platform.

“We’re very pleased to complete this acquisition as it is a natural fit and extension of our successful partnership with LIVMOR and our complementary goals to dramatically improve patient outcomes and to significantly reduce healthcare system costs. The fact that these intellectual property and product assets were developed by the technical team that is now part of HeartBeam means that we will be able to integrate the Halo cloud-based software platform with our AIMGO solution in an efficient and cost-effective manner.”

Branislav Vajdic, Ph.D., HeartBeam CEO, and Founder

According to DelveInsight’s “Digital Health Market” report, the global digital health market was valued at USD 178.37 billion and is estimated to grow at a CAGR of 18.25% during the forecast period from 2022 to 2027 to reach USD 486.55 billion by 2027. The digital health market is observing remarkable market growth due to the growing awareness of health, the adoption of digital healthcare, and the rising demand for IoT, AI, and others in the healthcare industry. 

Further, the increasing patient pool suffering from chronic disease and the rising burden of the geriatric population across the globe will increase the need for remote and virtual patient care, leading to the increased demand for digital health, increasing penetration of smartphones in the healthcare industries, among others during the forecast period from 2022 to 2027. 

PADM Medical Received the US Food and Drug Administration (FDA) 510(k) Clearance for PRECISION ECO™ 

On March 13, 2023, PADM Medical Group of Companies (PADM Medical Canada and PADM Medical USA), a global leader in the design and development of sustainable medical consumables and eco-friendly sustainable medical products, announced the 510(k) clearance from the US Food and Drug Administration (FDA) to market its PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops, which is the world’s first plant-based, procedural mask for use in healthcare and medical settings in the United States of America. 

PADM Medical’s PRECISION ECO™ Plant Based procedural masks are made with ECOFUSE™ plant-based materials manufactured by Roswell Textiles, a sister company of PADM Medical in Calgary, Alberta. ECOFUSE™ materials are made from renewable crop resources and help to reduce the environmental impact of petroleum-based, single-use disposable face masks. The ECOFUSE™ materials are industrially compostable and, because they are plant-based, help PRECISION ECO™ reduce CO2 emissions by approximately 55% when compared to conventional petroleum-based masks. As a result of the net carbon reduction, PRECISION ECO™ procedural masks generate carbon credits.

Furthermore, with an 82% bio-based content, the PRECISION ECO™ Compostable/Plant-Based Procedural Mask with Earloops is a USDA Certified Bio-based product under the USDA BioPreferred Program.

“The FDA 510(k) clearance is the highest level of validation available for the use of ECOFUSE™ materials in one of the strictest regulatory environments possible – healthcare. Roswell Textiles’ ECOFUSE™ materials are allowing manufacturers to reduce the carbon footprint of their existing product lines, without sacrificing performance or technical standards. We are honored to have worked alongside PADM Medical as they pursued this momentous achievement. This opens the doors to ECOFUSE™ materials becoming the new standard plant-based material for healthcare single-use disposables (gowns, drapes, sheets, wraps, and others). If a hospital could reduce their carbon emissions by up to 55% per product line as a result of a more sustainable supply chain decision, why wouldn’t they do that?”

Kyle Fiolka, President of Roswell Textiles and Chief Innovation Officer for the PADM Group.

“The 510(k) Clearance on the 82% plant-based PRECISION ECO™ product is a tremendous milestone, not only for PADM Medical but also for the healthcare industry and our planet. For the first time, the US healthcare system now has a plant-based medical-grade face mask alternative that provides the same level of protection as a traditional synthetic plastic product. Our PRECISION ECO™ mask achieves a net 55% reduction in carbon emissions and minimizes the larger environmental damage caused by the millions of tonnes of synthetic plastic medical waste that is generated on an annual basis by traditional face masks. It is this commitment to our planet that drives us as a company as we continue to innovate for a greener and more sustainable world.”

Martin Petrak, PADM Medical Group CEO

According to DelveInsight’s “Surgical Mask and Respirator Market” report, the global surgical mask and respirator market is estimated to grow at a CAGR of 5.31% during the forecast period from 2022 to 2027. The increase in demand for surgical masks and respirators is primarily attributed to the increasing number of surgeries due to the increasing prevalence of chronic disorders. Further, the surge in epidemic and pandemic outbreaks will increase the overall market of surgical masks and respirators, as these devices are used to prevent the transmission of the virus. 

Additionally, the increasing prevalence of airborne and respiratory disorders due to excessive exposure to pollution and chemicals worldwide is anticipated to bolster the market, thereby contributing to the growth of the surgical mask and respirator market during the forecast period from 2022-2027.

Kardium Announced Treatment Delivery to the First Patients in Pulsed-Field Ablation Study

On March 15, 2023, Kardium announced that it had successfully treated the first patient in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system.

Based in Vancouver, British Columbia, Kardium recently obtained an investigational device exemption (IDE) from the FDA to conduct the study. The international, multicenter PULSAR study aims to assess the safety and efficacy of Globe PF for the treatment of AFib with PFA.

Kardium anticipates that the PULSAR study will enroll over 400 patients across up to 35 sites. These locations are spread across the United States, Canada, and Europe. The principal investigators for the study are Dr. Vivek Reddy (Mt. Sinai Hospital, New York) and Dr. Atul Verma (McGill University Health Centre, Montreal). 

“From our experience with the PULSE-EU study, we have found the Globe System can provide rapid and durable treatment of AFib and has so far demonstrated exceptional rates of effectiveness. I am excited to begin treating patients in the PULSAR IDE study,”

Dr. Vivek Reddy, Mt. Sinai Hospital, New York

According to DelveInsight’s “Cardiac Ablation Devices Market” report, the global cardiac ablation devices market was valued at USD 2.25 billion in 2021, growing at a CAGR of 12.77% during the forecast period from 2022 to 2027, to reach USD 4.63 billion by 2027. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Further, growth in new therapies, technological advancements, increasing geriatric population, and penetration and acceptance of cardiac ablation devices in emerging countries will drive the market growth during the forecast period from 2022-2027.