September 22, 2021

W. L. Gore & Associates améliore le portefeuille d’endoprothèses GORE® VIABAHN® avec la pose d’un profil plus bas

Les améliorations apportées aux dispositifs de grand diamètre comprennent l’accessibilité par des gaines plus petites tout en permettant une meilleure visualisation grâce à l’ajout de marqueurs radio-opaques

25 ans d’innovation continue

PUTZBRUNN, Allemagne, 22 septembre 2021 /PRNewswire/ — Dans le cadre de ses efforts pour améliorer continuellement les solutions médicales pour les patients souffrant de maladies vasculaires complexes, W. L. Gore & Associates, Inc. (Gore) a annoncé le lancement dans la région EMEA de l’endoprothèse GORE^® VIABAHN^® à profil plus bas et à grand diamètre avec surface bioactive PROPATEN. Les améliorations apportées à ce dispositif s’appuient sur une endoprothèse leader sur le marché, qui est devenue un outil important pour le traitement des maladies vasculaires complexes. La conception innovante du dispositif VIABAHN^® réduit le profil de pose des grandes endoprothèses de 9 à 13 mm de diamètre jusqu’à 3 CH, ce qui permet de les poser dans des gaines plus petites. Des gaines d’introduction plus petites ont permis de réduire le risque de complications liées à l’accès vasculaire chez certaines populations de patients.¹ En outre, de nouveaux marqueurs radio-opaques, désormais présents sur les configurations de dispositifs de plus grand diamètre, améliorent la visualisation sous fluoroscopie, facilitant le positionnement et la pose du dispositif, ainsi qu’un placement précis et prévisible. « Outre les marqueurs radio-opaques qui facilitent le positionnement et le déploiement, le nouveau profil plus bas permet d’utiliser une gaine plus petite, ce qui réduit potentiellement le risque de dommages au niveau du site d’accès », a déclaré Manuel Alonso, docteur en médecine, chirurgien vasculaire, Oviedo, Espagne. « Associée à la traçabilité et à la flexibilité, cette nouvelle offre de profil plus bas deviendra très utile dans ma pratique pour traiter les patients complexes dans tous les états pathologiques. »

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

« L’histoire de l’endoprothèse GORE^® VIABAHN^® est l’histoire d’une collaboration entre médecins pour quatre indications centrées sur le patient et d’une performance prouvée à maintes reprises », a déclaré Benjamin Beckstead, responsable de la catégorie vasculaire chez Gore.

Depuis son lancement dans l’UE en 1996, le dispositif a évolué grâce à de nombreuses améliorations et a pris en charge des centaines de milliers de patients dans le monde entier. Actuellement, le dispositif VIABAHN^® est utilisé dans de nombreuses indications cliniques telles que les lésions de l’artère fémorale superficielle (AFS), les lésions iliaques, la resténose intra-stent des lésions de l’AFS et les lésions du circuit d’accès artério-veineux (AV).*

Pour plus d’informations, rendez-vous sur le site https://www.goremedical.com/eu/products/viabahn

* Pour obtenir des indications complètes et d’autres informations importantes sur la sécurité des produits commerciaux Gore mentionnés dans le présent document, reportez-vous aux instructions d’utilisation.

1. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. JACC : Cardiovascular Interventions 2008;1(3):317-326.

Gore conçoit des dispositifs médicaux qui traitent toute une série de maladies cardiovasculaires et d’autres problèmes de santé. Avec plus de 50 millions de dispositifs médicaux implantés pendant plus de 45 ans, Gore s’appuie sur sa réputation pour améliorer le pronostic des patients à travers la recherche, la formation et la démarche qualité. L’efficacité des produits, la facilité d’utilisation et la qualité du service permettent aux médecins, aux hôpitaux et aux assureurs de réaliser des économies significatives. Gore est au service des cliniciens et grâce à cette collaboration, nous améliorons des vies.

À propos de Gore

W. L. Gore & Associates est une entreprise internationale spécialisée dans la science des matériaux et dont l’objectif est l’amélioration du secteur et des conditions de vie. Depuis 1958, Gore répond à des défis techniques complexes dans des environnements exigeants – de l’espace aux plus hauts sommets du monde en passant par le fonctionnement interne du corps humain. Avec plus de 11 000 associés et une forte culture axée sur le travail en équipe, Gore génère un chiffre d’affaires annuel de $3,8 milliards de dollars.

gore.com

Les produits énumérés peuvent ne pas être disponibles sur tous les marchés.

GORE, together, improving life, PROPATEN et HELEX, et les modèles sont des marques déposées de W. L. Gore & Associates.

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September 22, 2021

W. L. Gore & Associates Enhances GORE® VIABAHN® Endoprosthesis Portfolio With Lower Profile Delivery

Improvements to large diameter devices include accessibility through smaller sheaths while providing enhanced visualization by adding radiopaque markers

25 years of continued innovation

PUTZBRUNN, Germany, Sept. 22, 2021 /PRNewswire/ — As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. (Gore) announced the EMEA launch of the lower profile, large diameter GORE^® VIABAHN^® Endoprosthesis with PROPATEN Bioactive Surface. The device enhancements build on a market-leading stent graft device, which has become an important tool for treating complex vascular disease. The innovative VIABAHN^® Device design reduces the delivery profile for larger 9–13 mm diameter stent grafts by up to 3 Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations.¹ Additionally, new radiopaque markers, now also on the larger diameter device configurations, enhance visualization under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement. “In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site,” said Manuel Alonso, M.D., Vascular Surgeon, Oviedo, Spain. “Combined with the trackability and flexibility this new lower profile offering will become very instrumental for treating complex patients across disease states in my practice.”

“The story of the GORE^® VIABAHN^® Endoprosthesis is a story of physician collaboration across four patient-centric indications and of proving performance over and over,” said Benjamin Beckstead, Gore Vascular Category Leader.

Since its EU launch in 1996, the device has evolved with numerous enhancements and supported hundreds of thousands of patients worldwide. Currently, the VIABAHN^® Device is used in various clinical indications such as in superficial femoral artery (SFA) lesions, iliac lesions, in-stent restenosis of SFA lesions and AV Access circuit lesions.*

For more information, visit https://www.goremedical.com/eu/products/viabahn

* For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

1. Applegate RJ, Sacrinty MT, Kutcher MA, et al. Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. JACC: Cardiovascular Interventions 2008;1(3):317-326.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives.

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 11,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.8 billion.

gore.com

Products listed may not be available in all markets.

GORE, Together, improving life, PROPATEN, VIABAHN and designs are trademarks of W. L. Gore & Associates.

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September 22, 2021

Report: Drugmakers Fall Short on Offering COVID Vaccines to Poorer Nations

Amnesty International is accusing the world’s leading pharmaceutical companies of creating an “unprecedented human rights crisis” by failing to provide enough COVID-19 vaccines for the world’s poorest nations.

In a report issued Wednesday, the human rights advocacy group says AstraZeneca, Johnson & Johnson, Moderna, Novavax and the partnership of Pfizer and BioNTech have “failed to meet their human rights responsibilities” by refusing to participate in global vaccine sharing initiatives and share vaccine technology by waiving their intellectual property rights.

Amnesty says only a “paltry” 0.3% of the 5.76 billion doses of COVID-19 vaccines distributed around the world have gone to low-income countries, while 79% have gone to upper-middle and high-income countries. It says the disparity is “pushing weakened health systems to the very brink and causing tens of thousands of preventable deaths every week,” especially in parts of Latin America, Africa and Asia.

The organization says Pfizer, BioNTech and Moderna alone are set to make $130 billion combined by the end of 2022.

“Profits should never come before lives,” said Agnès Callamard, Amnesty International’s secretary general.

Amnesty is calling on governments and pharmaceutical companies to immediately deliver 2 billion doses of COVID-19 vaccines to low and lower-middle income countries to meet the World Health Organization’s goal of vaccinating 40% of the population of such countries by the end of the year.

COVID Summit

The report was issued ahead of U.S. President Joe Biden’s virtual COVID Summit, held in conjunction with this week’s United Nations General Assembly. Biden is expected to announce a global vaccination target of 70% along with an additional purchase of 500 million doses of the two-shot Pfizer vaccine, bringing the United States’ overall donations to more than 1.1 billion doses.

“America is committed to beating COVID-19. Today, the United States is doubling our total number of global donated vaccines to more than 1.1 billion. For every shot we’ve put in an American arm to date, we are donating three shots globally,” U.S. Secretary of State Antony Blinken said Wednesday on Twitter.

Extreme poverty

The Asian Development Bank says the pandemic likely pushed as many as 80 million people in Asia’s developing nations into extreme poverty last year. A report issued Tuesday by the Manila-based institution said the region’s developing economies will likely grow at a slower-than-expected pace in 2021 due to lingering COVID-19 outbreaks and the slow pace of vaccination efforts

The ADB is predicting Southeast Asian economies to grow by just 3.1 percent this year, a drop from the 4.4 percent rate forecast in its economic outlook back in April.

Source: Voice of America

September 22, 2021

Researchers Detect Malaria Resistant to Key Drug in Africa

Scientists have found evidence of a resistant form of malaria in Uganda, a worrying sign that the top drug used against the parasitic disease could ultimately be rendered useless without more action to stop its spread.

Researchers in Uganda analyzed blood samples from patients treated with artemisinin, the primary medicine used for malaria in Africa in combination with other drugs. They found that by 2019, nearly 20% of the samples had genetic mutations, suggesting the treatment was ineffective. Lab tests showed it took much longer for those patients to get rid of the parasites that cause malaria.

Drug-resistant forms of malaria were previously detected in Asia, and health officials have been nervously watching for any signs in Africa, which accounts for more than 90% of the world’s malaria cases. Some isolated drug-resistant strains of malaria have previously been seen in Rwanda.

“Our findings suggest a potential risk of cross-border spread across Africa,” the researchers wrote in The New England Journal of Medicine, which published the study Wednesday.

The drug-resistant strains emerged in Uganda rather than being imported from elsewhere, they reported. They examined 240 blood samples over three years.

Malaria is spread by mosquito bites and kills more than 400,000 people every year, mostly children under 5 and pregnant women.

Resistance has ‘a foothold’

Dr. Philip Rosenthal, a professor of medicine at the University of California- San Francisco, said that the new findings in Uganda, after past results in Rwanda, “prove that resistance really now has a foothold in Africa.”

Rosenthal, who was not involved in the new study, said it was likely there was undetected drug resistance elsewhere on the continent. He said drug-resistant versions of malaria emerged in Cambodia years ago and have now spread across Asia. He predicted a similar path for the disease in Africa, with deadlier consequences given the burden of malaria on the continent.

Dr. Nicholas White, a professor of tropical medicine at Mahidol University in Bangkok, described the new paper’s conclusions about emerging malaria resistance as “unequivocal.”

“We basically rely on one drug for malaria, and now it’s been hobbled,” said White, who also wrote an accompanying editorial in the Journal.

He suggested that instead of the standard approach, where one or two other drugs are used in combination with artemisinin, doctors should now use three, as is often done in treating tuberculosis and HIV.

White said public health officials need to act to stem drug-resistant malaria, by beefing up surveillance and supporting research into new drugs, among other measures.

“We shouldn’t wait until the fire is burning to do something, but that is not what generally happens in global health,” he said, citing the failures to stop the coronavirus pandemic as an example.

Source: Voice of America

September 22, 2021

Malians March Against ‘Foreign Meddling’ on Independence Day

An estimated 3,000 Malians marched Wednesday through the streets of Bamako on the country’s day of independence from France.

Protesters, many of whom were against what they perceive as “foreign meddling,” marched in support of the military government, as Colonel Assimi Goita, Mali’s interim president, faced pressure from Western governments to cancel a deal with Russian security firm Wagner.

Over the past week, Paris in particular has expressed concern over a reported deal between Bamako and Moscow to hire 1,000 mercenaries.

“Such a choice would be one of isolation,” French Defense Minister Florence Parly said Monday during a visit to Mali.

Germany and the European Union have also expressed concern about the deal.

But demonstrators throughout the country Wednesday seemed to support the deal, with some carrying Russian flags in addition to Malian flags and pro-military placards, Agence France-Presse reported.

France, the country’s former colonial ruler, has thousands of troops in Mali to help fight a jihadist resurgence throughout the country. But many in Mali consider the mission a failure, and protests against the French military presence have taken place before.

In addition to their worries about the deal with Russia, many Western powers and Malian neighbors have expressed concern that the military government may fail to hold elections early next year as promised.

Goita and his military government took power in a coup in May, just months after new leadership had been chosen. Goita, who also led a coup that overthrew the elected government last October, said the transitional government had violated an agreement to advise him on a cabinet reshuffle.

Source: Voice of America

September 22, 2021

Rights Groups Condemn Rwandan Court Conviction of Paul Rusesabagina

Rights groups in Africa have condemned the Rwandan High Court’s sentencing of Paul Rusesabagina, made famous in the Hollywood film Hotel Rwanda, to 25 years in prison. The court on Monday found Rusesabagina and 20 other suspects guilty of terrorism. Rusesabagina denies the charges, and critics say his arrest and trial did not meet international standards for justice.

Bahima Macumi fled to Kenya more than 20 years ago following Rwanda’s civil war, but has been following Rusesabagina’s trial closely.

He said Rusesabagina clearly did not get a fair trial.

He says this shows the Rwandan government does not want to be corrected, because if it did, they would have at least listened to this person who saved over 1,000 people. He says if the person who saved over 1,000 people can be called a terrorist, what would they call the one who did not save anybody?

To the world at large, Rusesabagina is a hero for sheltering at-risk Tutsis and Hutus in the Kigali hotel he managed during the 1994 Rwandan genocide.

To the Rwandan government, he is a threat, a fierce critic of President Paul Kagame who allegedly supported a militia group that seeks to overthrow the Rwandan government.

Human rights advocates are condemning his conviction.

According to Amnesty International, the Monday court ruling puts in question the fairness of Rwanda’s judicial system when it comes to high-profile and sensitive cases.

Sarah Jackson is Amnesty’s deputy regional director for East Africa, the Horn of Africa and the Great Lakes.

“We found many fair trial violations, including his unlawful rendition to Rwanda, his imposed disappearance at the beginning of the case and his initial inability to select a lawyer of his own choosing and all of these things during the pretrial period impact the fairness of the trial itself,” Jackson said.

Rusesabagina has 30 days to appeal his conviction, but rights groups doubt that judges can make an impartial decision on the case. Human Rights Watch’s Lewis Mudge explains.

“Unfortunately, this case has become an emblematic case in Rwanda so much that it really does highlight the lack of independence in the judiciary,” Mudge said. “It’s difficult for us to say that an appeal should happen or will happen because that will imply a degree of confidence in the judicial system that is currently in Rwanda.”

Rusesabagina says he was tricked into going to Rwanda in August of 2020. He had boarded a flight in Dubai that he believed was bound for Burundi, only for the flight to land in Kigali, where he was quickly arrested.

He went on trial along with 20 others in February. U.S State Department spokesman Ned Price Monday said the reported lack of fair trial in Rusesabagina’s case calls into question the fairness of the verdict. Rwandan prosecutors maintain the trial was fair.

Source: Voice of America