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Medical Devices

Glaukos Announces Australia’s TGA Regulatory Approval for PRESERFLO™ MicroShunt

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SAN CLEMENTE, Calif.–(BUSINESS WIRE)– Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that the Therapeutic Goods Administration (TGA) of Australia has granted regulatory approval for the PRESERFLO MicroShunt intended for the reduction of intraocular pressure (IOP) in eyes of patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.

“We are delighted to receive regulatory approval from Australia’s TGA for the MicroShunt, marking a notable milestone in advancing our goal to bring this important late-stage glaucoma technology to ophthalmic surgeons and patients,” said Thomas Burns, Glaukos president and chief executive officer. “We believe there is a strong appetite within the global ophthalmic community for the MicroShunt as a more elegant, ab-externo alternative to conventional filtration surgeries for late-stage glaucoma management. We are excited for the opportunity to leverage our best-in-class sales organization to bring this novel technology to patients in Australia.”

The PRESERFLO MicroShunt is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications or where glaucoma progression warrants surgery. IOP reduction is the most effective means of preventing the progression of glaucoma and vision loss. Made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], the PRESERFLO MicroShunt is a flexible, 8.5-mm-long tube with planar fins to help fixate the device in the tissue through a micro-incision and prevent leakage and migration.

Glaukos plans to commence initial commercial launch activities for the MicroShunt in Australia in late 2021, with a full commercial launch targeted in mid-2022 following the establishment of formal reimbursement.

Under its current development and commercialization license agreement with Santen Pharmaceutical Co., Ltd. (Santen), Glaukos has exclusive commercialization and development rights for the MicroShunt in Australia. In addition, Glaukos also has exclusive commercialization rights and control of all development activities, including over clinical development and regulatory affairs activities, for the MicroShunt in the United States, Canada, New Zealand, Mexico, Brazil and the remainder of Latin America.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.

About Santen

As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing and sales of pharmaceuticals, over-the-counter products and medical devices, and its products now reach patients in over 60 countries. Toward realizing “WORLD VISION” (Happiness with Vision), the world Santen ultimately aspires to achieve, as a “Social Innovator”, the company aims to reduce the social and economic opportunity loss of people around the world caused by eye diseases and defects by orchestrating and mobilizing key technologies and players around the world. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (www.santen.com).

Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the continued efficacy and safety profile of our products, including the PRESERFLO MicroShunt, the extent to which we may obtain regulatory approval for the MicroShunt in other markets, our ability to successfully commercialize such products in accordance with our targeted launch plans, and the ability to obtain adequate financial coverage and reimbursement. These and other risks, uncertainties and factors related to Glaukos and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which was filed with the Securities and Exchange Commission (SEC) on May 6, 2021, and our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 1, 2021. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210608005219/en/

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Source: https://www.biospace.com/article/releases/glaukos-announces-australia-s-tga-regulatory-approval-for-preserflo-microshunt/?s=93

Medical Devices

New Research Shows Nearly Half of Elderly Suffer Decreased Mobility During Lockdown

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Decreased Mobility During Lockdown: Kepler Vision Technologies, a global leader in computer vision monitoring technology, reveals that while people are still concerned about the possibility of elderly relatives catching Covid, day-to-day concerns such as loneliness, mental health and falling over are of an almost equal concern according to new research.

decreased mobility during lockdown, Kepler Vision Technologies

Parental Loneliness and Falls a Huge Worry for Brits

In a survey of UK adults with parents over the age of 75, while over half (52%) of respondents remain worried about their parents catching Covid, 48 percent are concerned about parental loneliness, and 46 percent about their parents falling alone and not being able to get up or get help. This figure remained high even among those whose parents are in care homes, with 37% of respondents still most concerned about parents falling over.

Physical Mobility in Elderly People Massively Impacted During Lockdown

There is also concern that the long-term effects on the mental and physical health of the elderly are still being felt. Four in ten respondents (41 percent) revealed that their parent’s physical fitness and mobility have decreased during the lockdown, as a result of being confined to homes for months at a time with little opportunity to exercise or physically engage with others.

Dr. Harro Stokman, CEO of Kepler Vision Technologies said: “With fears about Covid beginning to recede, those with older relatives are rightly concerned with the more common problems faced by the elderly both in care and while living alone. Issues such as loneliness and falling over are both exacerbated by the ongoing staffing crisis in the care industry and, with no new influx of care staff on the horizon, the children of elderly parents should be looking for solutions that provide them with the best possible care and dignity in their old age.”

Getting up from the floor after a fall is a challenge for the elderly. According to a study on the effects of falling among elderly people[1], even when not injured, 47% cannot get up without assistance. Remaining on the floor after a fall for a prolonged period increases morbidity and mortality, with an early study [2] finding that half of those who remained on the floor after a fall for an hour or longer passed away within 6 months. Another study [3] showed that 60% of those who were on the floor after a fall for more than an hour were admitted to the hospital in the follow-up year.

Kepler Vision’s Night Nurse solution is designed to alert relevant staff or carers immediately to elderly people that have experienced a fall, ensuring that they get assistance within minutes not hours, reducing the chances of further injury and health complications.

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Source: https://infomeddnews.com/decreased-mobility-during-lockdown-elderly-suffer/

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British Columbia First Province to Cover Dexcom G6 Continuous Glucose Monitoring System for People With Type 1 and Type 2 Diabetes on Intensive Insulin Therapy

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BURNABY, British Columbia–(BUSINESS WIRE)– Dexcom, Inc. (NASDAQ: DXCM), a leader in real-time continuous glucose monitoring (CGM), announced today that people with diabetes who are on intensive insulin therapy, age two years or older, may now be eligible for provincial coverage of the Dexcom G6 CGM System through BC PharmaCare. This coverage expansion is in line with Dexcom’s mission to make it easier for people living with diabetes to experience the benefits of using a CGM system for their diabetes management.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005428/en/

The Dexcom G6 CGM System now covered by BC PharmaCare for people living with diabetes who are on intensive insulin therapy. Back of the upper arm wear is available for users 18+. (Photo: Business Wire)

The Dexcom G6 CGM System now covered by BC PharmaCare for people living with diabetes who are on intensive insulin therapy. Back of the upper arm wear is available for users 18+. (Photo: Business Wire)

“Improved access to CGM technology elevates diabetes management for everyone in a patient’s circle of care. As an endocrinologist and medical director at a clinic specifically dedicated to diabetes care, I am appreciative that today’s announcement will benefit so many people in the province,” said Dr. Tom Elliott, Medical Director of B.C. Diabetes. CGM leads to better glycemic control for patients1,2 and gives physicians better insight into patients’ glucose levels to make treatment decisions. CGM use may lead to fewer trips to the emergency room by helping users avoid severe hypoglycemic episodes.4

British Columbia joins Yukon, Quebec and Saskatchewan to offer public coverage of CGM systems under provincial health plans. In addition, Prince Edward Island and Manitoba have also recently announced plans for funding based on their 2021 budget platforms. For coverage in B.C., patients must meet the coverage criteria, be enrolled in eligible PharmaCare plans, and meet any deductible requirements. Today’s announcement marks a significant accomplishment in increasing access to life changing technology used in the management of diabetes and recognizes the impact CGM technology can have on those who require intensive insulin therapy to manage their type 2 diabetes as well as those living with type 1 diabetes.

“As a BC-based company, we are thrilled by today’s announcement and the province’s commitment to the diabetes community,” says Laura Endres, Vice President and General Manager of Dexcom Canada. “We have seen the impact of improved access to CGM to truly change lives, and we look forward to continuing our work toward access for all those impacted by diabetes across Canada.”

The Dexcom G6 CGM System includes a small, wearable sensor that measures glucose just below the skin; a transmitter to continuously and wirelessly send glucose levels to a display device; and a compatible smart device* or receiver that displays real-time glucose data to users without the need for fingersticks or scanning. And with real-time alerts, including a predictive Urgent Low Soon alert, the Dexcom G6 can warn the user in advance of hypoglycemia — allowing time to take appropriate action before it happens — day or night. As part of the BC PharmaCare coverage program, users will now be able to pick up their Dexcom CGM supplies through a participating local pharmacy.

For more information about the coverage criteria for BC PharmaCare, please visit https://www.dexcom.com/en-CA/public-coverage and BC PharmaCare’s website section related to Diabetes Supplies.

About Dexcom, Inc.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California in the United States, and with operations in Canada, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.

If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

* For a list of compatible devices, please visit dexcom.com/compatibility

Dr. Tom Elliott was not compensated for any media work. He has been a paid speaker for Dexcom Canada, Co.

References


1 Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial. JAMA 2017;317(4):371-8.

2 Welsh JB, Gao P, Derdzinski M, et al. Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems. Diabetes Technol Ther 2019;21(3):128-32.

3 Roze S, Isitt J, Smith-Palmer J, Lynch P. Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor Versus Self Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. Poster presentation presented at: 2020 Canadian Association for Population Therapeutics; October 27, 2020.

4 Mulinacci G, Alonso GT, Snell-Bergeon JK, Shah VN. Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. Diabetes Technol Ther 2019;21(1):6-10.

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Source: https://www.biospace.com/article/releases/british-columbia-first-province-to-cover-dexcom-g6-continuous-glucose-monitoring-system-for-people-with-type-1-and-type-2-diabetes-on-intensive-insulin-therapy/?s=93

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Orthofix Announces Participation in Upcoming JMP Securities Life Sciences Conference

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June 11, 2021 11:01 UTC

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced that President and Chief Executive Officer Jon Serbousek and Chief Financial Officer Doug Rice will participate in a fireside chat during the upcoming JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 11:00 a.m. ET. The conference will be held in a virtual format, and one-on-one meetings will be held before and immediately following the fireside chat.

A live audio webcast will be available on the Company’s website at ir.orthofix.com/events-and-presentations/.

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions while partnering 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210611005084/en/

Source: Orthofix Medical Inc.

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Source: https://www.biospace.com/article/releases/orthofix-announces-participation-in-upcoming-jmp-securities-life-sciences-conference/?s=93

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Evaluation of the use of midline peripheral catheters for the purpose of blood collection

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Midline intravenous catheters (MCs) have been used in clinical settings since the 1950s and are an alternative for intravenous (IV) access for giving infusions and medications for long-term therapy in patients who have limited IV access and can be used up to one month duration.  Accessing the midline catheter for blood sampling is sometimes used for those patients who have difficult IV access and those with the need for frequent blood sampling for testing.  Studies have reported on the outcomes of using MCs, however, little is known or reported about the procedures used to sample blood from midline catheters or outcomes from using the MC for this purpose. While the Infusion Nursing Society (INS) standards include recommendations for blood sampling from central venous and short peripheral catheters (SPCs), the newest INS 2021 standards indicate that, while midline catheters might be used to obtain blood samples, there was no evidence available regarding the processes or outcomes of performing this procedure.

In general, IV catheters are intended for giving fluids or medications in a forward, antegrade flow rather than a backwards, retrograde flow when withdrawing blood to test for patency or for laboratory testing. The impact of the flow dynamics and effects on IV catheter performance and vasculature when withdrawing blood from MC is not well known and no recommendations or procedures exist for sampling blood from midline catheters, although it is known that this is performed in the clinical setting.

Hemolysis, the injury or splitting (lysis) of red blood cells, is an unintended and unwelcome consequence of sampling blood from intravenous catheters. The release of contents in red blood cells when “lysed” can alter some blood test values, making blood samples unusable for analysis.  This may result in the need to draw another blood sample with potential delays in care, repeated venipunctures and vein injury, and financial impact. Using SPCs for blood sampling is associated with increased hemolysis and may result from mechanical shearing and turbulence encountered during withdrawal of blood. The American Society for Clinical Pathology recommends that hemolysis rates at or below 2%, and reports rates from 3-32% hemolysis occurring in acute clinical settings.

Midline Catheter Design Changes to Improve Blood Draw
Recently, anecdotal feedback from practitioners experiencing hemolyzed samples when withdrawing blood samples from midline catheters prompted a company to develop a change in their midline catheter to overcome hemolysis. After conducting laboratory studies on fluid dynamics when withdrawing blood through the catheter lumen, the company designed the MC with a reinforced tip to reduce hemolysis during backwards flow when withdrawing blood for sampling. This MC (PowerGlide Pro™; BD, Salt Lake City, UT) received 510K clearance from the U.S. Food and Drug Administration in September 2016. However, this MC had not undergone assessment in a real clinical setting to evaluate for performance and rates of hemolysis and was needed.

Given that little to no evidence was found in the literature about procedures or clinical outcomes from using MCs for blood sampling, my  colleagues and I at Orlando Health conducted an observational study to explore the practices used by clinicians and outcomes when using the MC for blood collection.

The purpose of this study was to assess the processes and outcomes of using the MC to sample blood for laboratory testing. We aimed to evaluate the MC in an acute care setting for hemolysis rates when blood was drawn from the MC for laboratory analysis, catheter outcomes, and nurses’ practices and perceptions when sampling blood from the MC. Since only the MC with the reinforced tip was used at this facility, we only studied these outcomes in that particular catheter.

Our study findings were published in the most recent issue of the Journal of the Association for Vascular Access (JAVA), Volume 25, No. 4.

Study Findings
Findings from this study showed that we had very low rates of hemolysis and withdrawing blood from the catheter did not significantly impact dwell time of the ability to complete IV therapy. Since we only tested the one type of MC designed to lessen hemolysis, it is not known if these outcomes would be achieved with other types of MCs or in different settings. We found that MCs were mostly removed at discharge from the hospital, so it was not possible to determine longer-term outcomes from blood sampling or its effects on catheter dwell time if it were to have remained for longer periods of time.  We learned from focus groups with nurses, that they learned how to withdraw blood from MCs from their preceptors or other nurses and tended to use processes recommended for phlebotomy from other types of vascular access devices, such as central venous or short peripheral catheters.  Since there are still no recommendations from the Infusion Nurses Society about using MC for blood withdrawal, more information gained from this study helped inform nurse actions used for blood withdrawal from MCs and opportunities still exist to develop procedures and practices for this purpose.

Recommendations for Practice
This was the first study of this kind known to evaluate the outcomes and processes used for blood withdrawal for sampling from a midline catheter. Thus, more information and studies are needed to develop and evaluate outcomes using other types of MCs and in other settings.  Further, other recommendations are to develop and test procedures for blood sampling from MCs to contribute to and establish standards of practice in this area.

Editor’s Note: The study mentioned in the article was funded by Becton Dickinson. The author has no financial relationship with BD .

Photo: Anastasia Usenko, Getty Images

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Source: https://medcitynews.com/2021/06/evaluation-of-the-use-of-midline-peripheral-catheters-for-the-purpose-of-blood-collection/

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