TecTraum’s pro2cool® receives FDA Breakthrough Device Designation for the Concussions treatment
On November 03, 2021, TecTraum Inc., working to develop the world’s first point-of-care treatment for concussions, announced that the US Food and Drug Administration (FDA) has provided a Breakthrough Device to its flagship technology, pro2cool®. This system is a novel, non-invasive hypothermic therapy device designed to decrease the cruelty of concussion symptoms and let patients return to their pre-injury baseline sooner. It offers localised cooling for the head and neck to lower blood temperature before it enters the brain.
TecTraum CEO John Zak, MD, MBA, said that they are incredibly proud to have TecTraum recognised by the FDA as a leader in concussion therapy as they work to commercialise the first-ever FDA approved concussions treatment. Although their initial focus is on filling an unmet medical need for athletes, they expect showing in the future that people suffering from concussions also can benefit from the pro2cool® medical device.
As per DelveInsight’s ‘Concussions Market’, the Breakthrough Devices designation to pro2cool® System will help the TecTraum position its place in treating concussions and provide a virtual medical device for young athletes.
Joseph Congeni, MD, director of Sports Medicine at Akron Children’s Hospital and the lead principal investigator of the pivotal multisite trial of pro2cool®, said that the FDA had provided input on the design and implementation of the trial. They all recognise that concussion is a growing burden in the U.S. Based on previously published data; they are hopeful that their current trial will show the efficacy, safety, and tolerability of this noninvasive treatment for mild traumatic brain injury that is also known as concussion.
Medtronic declares early data for the Intrepid™ transcatheter mitral valve replacement (TMVR) system using a new transfemoral delivery system
On November 06, 2021, Medtronic plc, a global leader in healthcare technology, shown early data for its self-expanding Intrepid™ transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation (MR) developing the transfemoral access route.
This result was presented as Late-Breaking Clinical Science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. The data comprising the first 15 patients enrolled in an Early Feasibility Study of the Intrepid Transfemoral System showed 100% survival and no stroke, a median procedure time of 46 minutes, and none/trace MR in all implanted patients at 30 days. The data were published simultaneously in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.
Firas Zahr, M.D., interventional cardiologist and co-director of the Complex Heart Valve Program at Oregon Health and Science University and investigator in the study, said that these data hint the new Intrepid Transfemoral Delivery System is a potential option for the delivery of the Intrepid valve with all patients in the study showing almost finish elimination of MR at 30 days. The addition of transfemoral access into the Apollo Trial will offer study investigators with an access route, which could present less risk to patients during the procedure.
According to DelveInsight’s ‘Mitral Valve Regurgitation Treatment Devices Market & Competitive Landscape, the leading companies working in the Mitral Valve Regurgitation Treatment Devices Market are Abbott, Medtronic, Livanova, Edwards LifeSciences, Braile Biomedica, Comed B.V., CMI’NOV, Neohord Inc, and many others. These positive results will boost the company’s share in the market.
Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic, said that the development of the Intrepid Transfemoral Delivery System is an essential milestone for the Intrepid TMVR program, and they are excited to introduce it into the Apollo Trial. They believe this advancement will expand their clinical trial offerings to more patients.
Alcon to buy Ivantis, Inc. and its Hydrus Microstent for Surgical Glaucoma, boosting Global Ophthalmology Portfolio
On November 08, 2021, Alcon, the global leader in eye care dedicated to helping people see brilliantly, plans to takeover Ivantis®, developer and manufacturer of the novel Hydrus® Microstent, a minimally-invasive glaucoma surgery (MIGS) device designed to decrease intraocular pressure for open-angle glaucoma patients in connection with cataract surgery. This acquisition will help the company bolster its glaucoma portfolio and a portfolio across cataract, refractive, and retina.
Alcon plans to pay USD 475 million to acquire Ivantis, Inc. and is expected to close in the first quarter of 2022.
David Endicott, CEO of Alcon, said that Glaucoma is the second-largest cause of blindness after cataracts, affecting more than 75 million people worldwide, with major unmet patient need. This transaction will let them add a uniquely effective product to their glaucoma portfolio around the world. Their global commercial footprint and development capabilities make them well-positioned to build on the success of Ivantis and help even more patients see brilliantly with Hydrus Microstent.
Dave Van Meter, President and CEO of Ivantis, added that with more than 85,000 Hydrus devices implanted, now is the time to extend access worldwide, and Alcon is the right partner as the global leader in eye care. They started this with a mission to bring unprecedented scientific rigour to the MIGS space, and they have been gratified and humbled by the rapid adoption of Hydrus since their launch in late 2018. Thanks to the continuous, resolute commitment of Ivantis employees and their investors, they now have the chance to bring the clinically proven Hydrus technology to more glaucoma patients globally.
According to DelveInsight’s “Glaucoma Drainage Devices Market & Competitive Landscape”, the market is expected to grow at a CAGR of 5.39% during the forecast period from 2021 to 2026. The demand for glaucoma drainage devices is primarily being boosted by rising geriatric population base, growing prevalence of lifestyle disorders such as hypertension and diabetes, increasing prevalence of glaucoma, and technical innovation in product development which are expected to drive the product demand, thereby contributing to the glaucoma drainage devices market growth in the forecast period.
The total diagnosed prevalent population of Glaucoma in the 7MM was 10,104,188 in 2020, which is expected to increase in the forecast period (2021-2030), according to DelveInsight’s “Glaucoma Market”.
Vektor Medical obtains FDA Clearance for vMap™, First Technology designed to recognise Arrhythmia hot spots anywhere in the heart in minutes using only ECG data
On November 09, 2021, the US Food and Drug Administration (FDA) provided 510(k) clearance to Vektor Medical, Inc. for its novel computational ECG mapping system, vMap™. This mapping system is developed to map potential arrhythmia sources (hot spots) associated with stable or unstable arrhythmias anywhere in the heart, including all four chambers, the septal wall, and the outflow tracts, in less than three minutes using only ECG data, to improve outcomes in ablation procedures.
Amir Schricker, MD, MS, Medical Director of Cardiac Electrophysiology at Mills-Peninsula Medical Center, a Sutter Health hospital, said that traditional arrhythmia mapping techniques are labour- and time-intensive and physicians are only able to achieve complete success in a limited number of ablation procedures owing to the lack of information on arrhythmia source locations. To decrease procedure times and enhance ablation success, electrophysiologists require to visualise arrhythmia hot spots in the heart quickly and accurately. Their clinical experience with vMap has been incredibly positive. Using non-invasive ECG data, the system is straightforward and fast to use and quickly provides a hot spot map. Hence, they know where to target their efforts without navigating the whole heart or ordering additional imaging.
Vektor Medical CEO Mike Monko added Cardiac arrhythmias affect millions of people globally, raising the risk of serious health-related issues. Yet, today’s therapies have significant problems – drug therapy can have severe side effects, and non-targeted ablation has disappointingly low success rates. With vMap, they are modifying how electrophysiologists contemplate about mapping. By offering a hot spot map in only minutes based on non-invasive ECG data, physicians can develop a more effective ablation plan and spend less time recognising target locations. Their goal is to increase first-pass success rates, lower risk, and decrease the healthcare system’s current cost burden of ablation.
According to DelveInsight’s “ECG Monitoring Equipment Market & Competitive Landscape”, the approval of a novel computational ECG mapping system, vMap™, will boost the non-invasive devices market and help treat patients with the risk of serious health-related issues, such as stroke and heart failure.
Philips to acquire Cardiologs to expand its cardiac diagnostics and monitoring portfolio
On November 08, 2021, Royal Philips, a global leader in health technology, signed an agreement to acquire Cardiologs, a France-based medical technology company developing cardiac diagnostics using artificial intelligence (AI) and cloud technology. This acquisition will enhance Philips’ cardiac monitoring and diagnostics portfolio with innovative software technology, electrocardiogram (ECG) analysis, and reporting services. Both companies did not disclose the transaction details.
Roy Jakobs, Chief Business Leader Connected Care at Royal Philips stated, proffering superb clinical data, as well as automated clinical reporting, Cardiologs’ medical-grade AI technology and data scientists will be a solid addition to their growing portfolio of cardiac solutions for hospital and ambulatory settings. Philips’s global footprint can accelerate the availability of Cardiologs’ technology to patients worldwide and further offer on the quadruple focus of an enhanced patient care experience, better health outcomes, enhanced staff experience, and decreased cost of care.
Yann Fleureau, Co-Founder and CEO of Cardiologs, added that they are happy to be a part of Philips and continue innovating together to offer solutions empowering clinicians worldwide. They look forward to the opportunity to expand the business as part of Philips, maintaining vendor neutrality and continuing to work with third-party vendors to drive further adoption of digital health solutions globally.
This acquisition will help Philips as Cardiologs’ technology is CE-marked and FDA cleared for diagnosis of cardiac arrhythmias, and its database has more than 20 million ECG recordings. The technology has gained support from several clinical publications. Under the agreement, approximately 70 employees, primarily software engineers and data scientists with expertise in AI and deep learning algorithms, of Cardiologs will join Philips. They will expand the company’s continued AI-focused innovation activities together with its R&D lab in Paris.
Sight Sciences announces FDA authorisation for the PRECISION Trial, a Ground-breaking Three-Arm Randomized, Controlled IDE Trial of Canal Viscodilation in combination with Cataract Surgery in adults with Primary Open-Angle Glaucoma (POAG)
On November 10, 2021, Sight Sciences, Inc., an eye care technology company working on developing innovative solutions intended to renovate standards of care and improve patients’ lives, announced the approval of Investigational Device Exemption (IDE) authorisation by the Food and Drug Administration (FDA) to conduct a clinical study to evaluate the safety and effectiveness of a new, higher volume (21 microliters of viscoelastic fluid dispensed), investigational OMNI® device (“higher volume OMNI”) to perform canal viscodilation alone to decrease intraocular pressure (IOP) in primary open-angle glaucoma adults.
The PRECISION clinical trial, which will be the first of its kind and represents the largest MIGS clinical trial ever initiated, is designed as a three-armed randomised controlled trial (RCT). OMNI (Sight Sciences) and the iStent Inject Canal Implant (Glaukos) devices will be evaluated in the study. The patients will receive one of the following treatments in conjunction with cataract surgery: (1) ab interno canaloplasty alone using higher volume OMNI; (2) sequential canaloplasty followed by trabeculectomy using higher volume OMNI; or (3) implantation of two trabecular micro bypass canal implants using iStent Inject.
Paul Badawi, Co-Founder, and CEO, Sight Sciences, said that they believe in their technology, comprising the potential of the higher volume OMNI to fulfil an unmet medical needs in POAG patients, and they are happy to develop robust clinical data under this IDE that could support an expanded indication for use for canal viscodilation alone without trabeculectomy. Compelling, multi-centre safety and effectiveness clinical data was necessary for FDA 510(k) clearance of their current combined OMNI indication for use in canaloplasty and trabeculectomy. They are now making the following needed clinical investments under this IDE to offer the FDA with robust clinical data, which could support the safety and effectiveness of a canaloplasty alone indication.