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iSTAR Medical receives U.S. FDA approval to start pivotal trial for MINIject in glaucoma patients

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World-leading surgeons to join iSTAR Medical’s STAR-V study

WAVRE, Belgium, July 15, 2021 /PRNewswire/ — iSTAR Medical, a med-tech company developing minimally-invasive implants for glaucoma surgery (MIGS), announced today that the U.S. Food and Drug Administration (FDA) granted it Investigational Device Exemption (IDE) to start a pivotal trial with MINIjectTM. The STAR-V study will investigate MINIjectTM in over 350 patients with primary open angle glaucoma. World-leading glaucoma surgeons in the US, Canada and Europe will join the trial.

MINIject implant made of proprietary STAR material

The STAR-V trial evaluates MINIject’s efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving at least a 20 percent reduction in eye pressure. This study will report on safety and efficacy of MINIject alone, in a procedure not combined with simultaneous cataract surgery. Key study findings will become available when all patients have completed 2 years in the study. Patients will also be followed to evaluate long-term benefits and tolerability of MINIjectTM in the treatment of mild to moderate glaucoma.

iSTAR Medical logo

Dr. Brian E. Flowers, a glaucoma specialist at Ophthalmology Associates of Fort Worth, TX, USA said “On behalf of the investigators, I would like to share our excitement to start the STAR-V trial. The supraciliary space of the eye is a natural outflow pathway which has demonstrated great promise. There is the potential to deliver increased efficacy in lowering eye pressure for our patients in a less invasive fashion. Access to an effective pressure lowering device that is used in a standalone procedure will enable us to offer treatment to many more glaucoma patients with a minimally-invasive treatment option.”

Michel Vanbrabant, CEO of iSTAR Medical, commented “We are very pleased that the FDA has granted us approval to bring this innovative technology to North American patients suffering from primary open angle glaucoma in the STAR-V trial. Results from clinical trials in over 130 patients in Europe, Asia and Latin America have consistently demonstrated that MINIjectTM maintains a positive safety profile, and delivers a significant reduction of pressure thanks to our proprietary STAR material and the power of the supraciliary space.”

About iSTAR Medical

iSTAR Medical SA is a private med-tech company developing minimally invasive ophthalmic implants for the treatment of glaucoma patients. iSTAR Medical has exclusive rights for ophthalmic use of the STAR® material, developed by the University of Washington, Seattle (USA). STAR has outstanding anti-fibrotic and anti-inflammatory properties and a unique porous structure that enhances natural fluid outflow. iSTAR Medical was founded in 2011 and is headquartered in Wavre, Belgium. www.istarmed.com

About MINIjectTM

MINIject is iSTAR Medical’s revolutionary MIGS device for patients with primary open-angle glaucoma. MINIject combines the unique porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.

About Glaucoma

Glaucoma is a progressive disease and the second leading cause of adult blindness,1 affecting over 100 million people globally.2 IOP reduction, through medication or surgery, helps delay disease progression.1 Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.1,2 Invasive surgery can present risks with irreversible complications.1,2 MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile.2 MINIject is potentially best-in-class for its promising long-term efficacy and safety.

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Source: https://www.biospace.com/article/releases/istar-medical-receives-u-s-fda-approval-to-start-pivotal-trial-for-miniject-in-glaucoma-patients/?s=93

Medical Devices

Cartessa Aesthetics’ Innovative Multi-Modality Treatment Leads Demand for Non-Invasive Body Procedures

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MELVILLE, N.Y., July 28, 2021 /PRNewswire/ — Cartessa Aesthetics recently launched its newest device, PHYSIQ, leading the demand for the latest advancement in body treatments. PHYSIQ is a novel, dual-modality system that offers deep heat to target tissue and electrical muscle stimulation (EMS) to re-educate muscle – all from one device and in one session. An incredibly versatile device, PHYSIQ’s four applicators can be individually adjusted to tailor the energy and modality delivered to one or more body areas. Providers can select EMS or deep heat only or they have the unique ability to deliver both modalities sequentially within one treatment to maximize results and overall comfort. Treatments are hands-free, require no downtime and can be completely customized to meet each patient’s unique body goals.

Cartessa Aesthetics has made a name for itself by working with leading global aesthetic manufacturers to introduce best-in-class devices to the North American market. With PHYSIQ, aesthetic providers and patients have an optimized body treatment distinct from existing technology in the space. 

“Optimizing clinical outcomes while providing best-in-class return on investment to physicians is at the core of Cartessa’s mission statement,” said Gabe Lubin, Cartessa Aesthetics Founder and CEO. “More people are favoring non-invasive procedures, even for treatments that address challenging body aesthetics. Patients want results, but without the pain and downtime that comes with surgery. Being able to offer a more complete patient treatment in a 30-minute session will offer providers a unique competitive advantage in the robust body market.”

The non-invasive body treatment category has erupted in the last decade. From 2011 to 2018 the number of procedures grew four-fold and it is estimated that by 2025, the North American market will hit $1.6 billion growing at an 8% compounded growth rate. PHYSIQ’s low consumable costs, minimal required staff-time and healthy patient demand makes it a premier investment opportunity for aesthetic providers. Sessions range from 24 to 36 minutes and the ability to address multiple body areas with multiple modalities in one session has established PHYSIQ as being truly unique in the body space.

Those interested in PHYSIQ can learn more by visiting www.physiqbody.com or reach out to a Cartessa Aesthetics agent via email at [email protected].

Approximate pricing, $500/session and up. Although results may be noticed after only the first treatment, PHYSIQ is administered in a series of 5 treatments/sessions, 1 treatment every 2 weeks.

About Cartessa Aesthetics, LLC.
Cartessa Aesthetics, LLC sources leading aesthetic medical devices for distribution to dermatologists, plastic surgeons, cosmetic physicians and medical spas. Cartessa selects the most cutting-edge technologies that offer clinically proven efficacy, patient safety, and the best possible investment for patients and professionals. The company’s portfolio includes VirtueRF, Motus AX & Motus AY, Tetra CO2 with CoolPeel and Luxea (all manufactured by DEKA), Subnovii Advanced Plasma Technology and Skinwave.  Cartessa is also the exclusive US partner for Quanta Systems.  

For more information visit: www.cartessaaesthetics.com 

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Source: https://www.biospace.com/article/releases/cartessa-aesthetics-innovative-multi-modality-treatment-leads-demand-for-non-invasive-body-procedures/?s=93

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Orthofix Announces US Launch and First Patient Implants with New fiberFUSE Strip – An Advanced Fiber Bone-Graft Solution Containing Cancellous Bone

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LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the launch and first patient implants with the fiberFUSE Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone. The fiberFUSE Strip is formulated as a convenient preformed bone-graft strip to enable optimized application for posterior cervical, posterior lumbar and degenerative spinal procedures.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728005105/en/

Image of the Orthofix fiberFUSE™ Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone. (Photo: Business Wire)

Image of the Orthofix fiberFUSE™ Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone. (Photo: Business Wire)

Comprised of natural 100-percent bone, the fiberFUSE Strip contains a unique mixture of mineralized cancellous and demineralized cortical bone, with no carrier added, to create a natural scaffold allowing for revascularization, cellular ingrowth and new bone formation.

“We are pleased to introduce this next-generation formulation in the fiberFUSE allograft line,” said Kevin Kenny, President of Orthofix Global Spine. “The fiberFUSE Strip delivers a high-quality advanced bone-graft option in a convenient, easy-to-use strip preparation. This technology advancement was developed as part of our strategy to provide procedurally-focused solutions for spine surgeons and their patients.”

MTF Biologics is the exclusive processor of the Orthofix fiberFUSE Strip. Their proprietary, validated aseptic processing methods retain the natural growth factors within the cortical fibers. The fibers interconnect, resulting in a pliable, cohesive graft. The cancellous matrix component provides a porous scaffold to allow ingrowth of host vasculature, osteoblasts and mesenchymal stem cells. The fiberFUSE Strip can be rapidly rehydrated with the surgeon’s reconstitution solution of choice.

About Orthofix

Orthofix Medical Inc. is a global medical device with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 60 countries via the Company’s sales representatives and distributors. For more information, please visit www.Orthofix.com.

About MTF Biologics

MTF Biologics is a global nonprofit organization that saves and heals lives by advancing tissue and organ donation, transplantation, and research. They provide unmatched service, resources, and expertise to donors and their loved ones who give the gift of life, people who depend on tissue and organ transplants, healthcare providers, and clinicians and scientists. MTF Biologics subsidiary, The International Institute for the Advancement of Medicine (IIAM), honors donors of non-transplantable organs by providing their gifts to the medical research community to combat and cure diseases. Their subsidiary, Statline, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospitals and patients that they serve. MTF Biologics sister organization, The German Institute for Cell and Tissue Transplantation (Deutsches Institute for Zell-und Gewebeersatz – DIZG) expands their reach to patients across the globe. For more information, visit mtfbiologics.org.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2020 (the “2020 Form 10-K”). In addition to the risks described there, factors that could cause or contribute to such differences may include, but are not limited to: the risk that surgeons may be slow to adopt the fiberFUSE Strip; the risk that future patient studies or clinical experience and data may indicate that treatment with the fiberFUSE Strip does not improve patient outcomes as much as previously believed, or otherwise call into question the benefits of its use to patients, hospitals and surgeons; the risk that the product may not perform as intended and may therefore not achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; the risk that insurance payers may decline to reimburse healthcare providers for the use of our products.

This list of risks, uncertainties and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005105/en/

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Source: https://www.biospace.com/article/releases/orthofix-announces-us-launch-and-first-patient-implants-with-new-fiberfuse-strip-an-advanced-fiber-bone-graft-solution-containing-cancellous-bone/?s=93

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Vyaire Medical Advances the Standard of Care in Low-Flow Oxygen Delivery

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CHICAGO, July 28, 2021 /PRNewswire/ — Vyaire Medical, the world’s largest medical device maker fully dedicated to improving breathing for every person around the world, today announced the availability of AirLife Open oxygen mask, a revolutionary new low-flow oxygen therapy device designed to advance the standard of care and improve the satisfaction of patients receiving low-flow oxygen therapy. The AirLife Open oxygen mask combines the best elements of traditional nasal cannula, oxygen mask and non-rebreather benefits in a single device that is revolutionary for low-flow oxygen therapy. This is achieved through the patented design and unique geometry of the mask openings that maintain higher oxygen concentrations without obtrusive structures. The mask’s design distributes oxygen flow through unique jet orifices, creating a soft curtain of oxygen around the nose and mouth, reducing the risk of rebreathing carbon dioxide resulting in a more comfortable patient experience. The AirLife Open mask is designed to allow patients to drink, eat and easily communicate without removing the mask, while delivering uninterrupted oxygen therapy.

For clinicians, AirLife Open provides the ability to adjust oxygen delivery from 1—15 LPM without disturbing the patient. What’s more, the unique design of AirLife Open allows access for certain procedures and the easy transfer of patients between areas of care. AirLife Open reduces the need to change out interfaces, improving workflow, reducing waste and cost while effectively delivering continuous oxygen therapy without compromising safety or quality.  

“Vyaire is leveraging our rich history of innovation and expansive knowledge in respiratory care to bring to market revolutionary devices like the AirLife Open mask that will advance patient comfort and care while reducing the burden on clinicians,” said Gaurav Agarwal, chief executive officer, Vyaire. “We incorporated feedback from customers and patients from across the world and we are thrilled that the results we have seen confirm that the new design delivers the revolutionary benefits AirLife Open provides.”

“The novel design of AirLife Open is the culmination of customer inputs and extensive benchtop testing,” said Michael Pedro, M.D., chief medical officer, Vyaire, and board-certified anesthesiologist. “The feedback from our limited commercial release exceeds our initial expectations as AirLife Open is delivering superior results both in maintaining oxygen concentrations and reducing the risk of rebreathing while providing patients with an enhanced, updated and more comfortable method of oxygen therapy.”

“We believe that when it comes to compliance and comfort, there shouldn’t be a tradeoff. AirLife Open is the first of many new innovations Vyaire will introduce that are patient-centric and improve the standard of care,” added Agarwal. “For far too long, innovation within the respiratory space has been dormant, and Vyaire is working to fill that void, bringing meaningful new consumable products to market that will help everyone breathe better.”

About Vyaire Medical
Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what’s possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.

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Source: https://www.biospace.com/article/releases/vyaire-medical-advances-the-standard-of-care-in-low-flow-oxygen-delivery/?s=93

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Medical Devices

BIOTRONIK’s Implantable Cardiac Monitor Receives Prestigious Industry Award

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BIOMONITOR IIIm Received Frost & Sullivan’s ‘Enabling Technology Leadership Award’ 2021 for its High Precision Implantable Cardiac Monitoring

BERLIN, July 28, 2021 /PRNewswire/ — In association with Heart Rhythm 2021, BIOTRONIK today announced that the latest implantable cardiac monitor (ICM), BIOMONITOR IIIm, has been recognized by internationally-renowned research analysts Frost & Sullivan as high-performing across a range of innovation and customer value criteria.

The increased prevalence of cardiac disease, paired with the need to deliver more individualized and efficient healthcare, means that the use of ICMs, which remotely transmit vital clinical data, are now more important than ever. BIOMONITOR IIIm is a miniature electrocardiogram (ECG) device which records, stores and transmits clinical data that is integral in the diagnosis and long-term monitoring of cardiac patients, with maximum precision and for an extended period of time.

The key data ICMs need to deliver are high quality, reliable ECGs that cardiologists can rely upon to support an expedited and accurate diagnosis. BIOMONITOR IIIm’s exclusive design is central to providing high rhythm fidelity and detection accuracy due to its high amplitude R-waves that average 0.7mVs and result in noise-free, reliable ECGs.

“This award recognizes that, BIOTRONIK’s innovative ICM design—integrating a flexible antenna—delivers superior, high definition ECGs with optimal P-wave visibility and larger signal amplitude,” said David Hayes, M.D., Chief Medical Officer, BIOTRONIK, Inc. “Higher amplitudes minimize signal noise to allow uninterrupted cardiac monitoring, enabling healthcare professionals to better diagnose and monitor patients around the clock.”

BIOTRONIK’s ICM incorporates RhythmCheck®, an algorithm which minimizes the instances of false positive atrial fibrillation (AF) detection. While AF sensitivity remains favorable, at 99.1 percent, while bradycardia, asystole and sudden heart rate drop are maintained at 100 percent, the false detection rate is decreased, helping minimize the clinician workload associated with reviewing non-actionable ECGs in already stretched clinics.

Importantly, BIOMONITOR IIIm is the only ICM with an FDA-cleared vital data sensor which measures patient activity, heart rate and body temperature. The interrelationship between these vital signs and cardiac health conditions is well-documented2. This meaningful digital health innovation can potentially provide earlier detection of infection and facilitates illness screening while patients are still at home, helping to further streamline remote patient management3.

“By allowing patients’ recorded cardiac rhythm disturbance to be automatically and wirelessly transmitted to physicians, the solution enables 24-hour monitoring from anywhere. The transmission compliance rate of the BIOTRONIK Home Monitoring solution is 98%, the highest in the industry,” said Dr. M. Sneha Maria, Senior Research Analyst at Frost & Sullivan. “Such efficacy is useful, especially during the COVID-19 pandemic, as physicians can continually monitor patients for warning signs without hospital visits.”

In its report, Frost & Sullivan also references BIOMONITOR IIIm’s industry-leading battery life of five and a half years and how the device’s flexible antenna, by design, adapts to the patient anatomy. In addition, it provides a patient-centered remote monitoring experience. These design specifications are some of the unique features which help support a smoother injection with an increased physician and patient experience.

To read the full Frost & Sullivan Enabling Technology Leadership Award report, click here.

References:

  1. Mariani J et al. BIO|CONCEPT.BIOMONITOR III. Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success. Journal of Electrocardiology. (2020).
  2. Jensen MM, Brabrand M. The relationship between body temperature, heart rate and respiratory rate in acute patients at admission to a medical care unit. Scand J Trauma Resusc Emerg Med 23, A12 (2015). https://doi.org/10.1186/1757-7241-23-S1-A12.
  3. Hayes, D, Reddy R and Whittington, H. Correlation of Vital Signs Facilitates Illness Screening in an Implantable Cardiac Monitor. BIOTRONIK, Inc., Lake Oswego, OR 2Micro Systems Engineering, Inc., Lake Oswego, ORAPHRS 2020.

Media Contacts:
Sarah Lahert
[email protected]
+49 (0) 30 68905-1414

About BIOTRONIK:
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.

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Source: https://www.biospace.com/article/releases/biotronik-s-implantable-cardiac-monitor-receives-prestigious-industry-award/?s=93

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