Boston Scientific (NYSE:BSX) introduced in the present day that it has initiated a world, voluntary recall of its Lotus Edge aortic valve system — and is instantly retiring the Lotus program.
Marlborough, Mass.-based Boston Scientific mentioned in a information launch that the recall of all unused stock of its Lotus Edge transcatheter aortic valve restore (TAVR) system is because of complexities associated to the product supply system and solely that — because the valve has achieved constructive and clinically efficient efficiency post-implant.
Sufferers presently implanted with Lotus Edge shouldn’t have any issues of safety to be involved about, in response to the corporate.
Contemplating the extra time and funding required to develop and reintroduce an enhanced supply system, Boston Scientific officers determined to retire the Lotus product platform instantly, ceasing all associated business, scientific, analysis & improvement and manufacturing actions.
The transfer seems to cede floor to Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT), which dominate the U.S. TAVR market.
Boston Scientific expects the choice to retire Lotus will lead to estimated whole pre-tax GAAP fees of between $225 million and $300 million, whereas about $100 million to $150 million will impression the corporate’s adjusted monetary outcomes. Many of the fees shall be recorded in the course of the fourth quarter of 2020, whereas it’s anticipated to be accretive to GAAP and adjusted earnings per share in 2021 by about 1¢ or 2¢ and impartial thereafter.
“Whereas we’ve got been happy with the advantages the Lotus Edge valve has supplied to sufferers, we’ve got been more and more challenged by the intricacies of the supply system required to permit physicians to totally reposition and recapture the valve,” Boston Scientific chairman & CEO Mike Mahoney said within the launch. “The complexity of the supply system, manufacturing challenges, the continued want for additional technical enhancements, and present market adoption charges led us to the troublesome choice to cease investing within the Lotus Edge platform. We’ll as an alternative focus our sources and efforts on our Acurate neo2 aortic valve system, Sentinel cerebral embolic safety system and different excessive progress areas throughout our portfolio.”
Evaluation from Jefferies discovered that, as Acurate gained’t be within the U.S. till 2024, Edwards Lifesciences may see two-point progress in its TAVR enterprise, whereas the choice to retire Lotus Edge may sap a couple of level for Boston Scientific in 2021.
The analysts mentioned the transfer from Boston Scientific locks the corporate out of the aggressive U.S. TAVR marketplace for one other two or three years, setting the corporate again after it was anticipated that Lotus Edge can be a “main progress engine.”
In September, a study found that as a result of every TAVR machine available on the market — there are three whole between Boston Scientific, Edwards Lifesciences and Medtronic — has “elementary variations in engineering options,” each has its personal particular strengths and limitations within the efforts to deal with aortic valve stenosis by means of TAVR.
Final month, Medtronic announced its plan to begin a randomized, head-to-head study with Edwards Lifesciences comparing two TAVR systems in sufferers with extreme symptomatic aortic stenosis (ssAS), primarily in girls.
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Documentary tells stories of hidden Jews of the Southwest
ALBUQUERQUE, N.M. (AP) – Their 400-year journey started with expulsion from Spain, continuing through Mexico with persecution by the Spanish Inquisition, finally setting in the American Southwest.
The physical journeys of secret Jews – conversos or crypto-Jews – ended in colonial times, but their internal journeys continue to this day.
Filmmaker Isaac Artenstein has captured some of the powerful stories in his latest project: “A Long Journey: The Hidden Jews of the Southwest.” It will premiere Nov. 19 on New Mexico PBS.
“As an ongoing resource for both cultural and historical discovery, NMPBS was pleased to work with the producers on not only presenting a side of history that many may not know, but of also looking at the modern-day people impacted by actions taken centuries ago,” says Franz Joachim, NMPBS general manger and CEO. “The story of the conversos or ‘crypto-Jews’ of the Southwest is a story of relevance and resilience, culture, humanity and faith, of interest beyond the Jewish community and internationally.”
In 1492, the Spanish monarchs decreed that all the Jews in Spain would have to convert to Catholicism or leave the country.
Of the several hundred thousand Jews living in Spain, about half went into exile, where they could continue to practice their faith openly.
The other half remained and converted. Five years later, the king of Portugal also issued an edict forcing the Jews in the country to convert.
Some of these conversos accepted baptism sincerely, but other converted in name only, while practicing their ancestral faith in secret.
Life became very difficult for these crypto-Jews, or secret Jews, as there developed within the Spanish Catholic Church an institution known as the Holy Office of the Inquisition. The Inquisition had no jurisdiction over Jews, but as Catholics, these crypto-Jews were vulnerable to persecution.
According to the New Mexico Jewish Historical Society, vestiges of this crypto-Jewish heritage can still be found among the Hispano community.
“Some families retain only suggestive practices, disconnected from any consciousness of a Jewish past, such as the lighting of candles on Friday night, observance of the Sabbath on Saturday, refraining from eating pork products, and male infant circumcision,” the historical society says. “In other cases, knowledge of a Jewish past has been passed down through the generations to the present time.”
The documentary brings to life the fascinating stories of contemporary individuals living an outwardly Catholic life whose secret was their hidden Jewish roots.
“This is the second documentary that I’ve done primarily in New Mexico,” he told the Albuquerque Journal. “I know settlers came to New Mexico very early, and there’s this deep history. You had a viceroy in New Mexico. The history is so rich.”
Artenstein says the documentary recounts stories of forced expulsion, with journeys to Mexico, southern Texas and northern New Mexico; the reawakening of long-obscured Spanish-Jewish traditions, the resilience of faith and culture, and the eventual triumph of acceptance and respect over tyranny and intolerance.
The stories are set against magnificent natural and cultural landscapes, accompanied by an original score by acclaimed composer Mark Adler.
“The film is a story about self-awareness and reaffirmation, and a celebration of the richness and diversity of Jewish and Latino cultures in the American Southwest that I believe all audiences will find engaging,” Artenstein says. “The Western frontier is, after all, one of the most influential myths in American culture.
Producer Paula Amar Schwartz and Artenstein also worked on the documentary “Challah Rising in the Desert: The Jews of New Mexico.”
“During audience discussions following the showings of ‘Challah Rising,’ we were stunned to have individuals open up and share their family stories of hidden Jewish roots; some cried as they told their story; others affectionately spoke of asking their parents, who are we? The responses varied but were usually veiled and imprecise,” Amar Schwartz says. ” ‘We are who we are,’ was one such response. This kept happening, and the more it happened the more we became aware of how much more there was to tell.”
Amar Schwartz had the privilege of getting to know Maria Apodaca, a founder of a group in Albuquerque that was meeting monthly to hold Sephardic Shabbat dinners and discuss the members’ family histories.
“Maria’s story was one of those told in ‘Challah Rising in the Desert.’ That group, with the support of the Jewish Federation of New Mexico, has now evolved into Centro Sefarad, New Mexico, with leadership drawn from around the world,” she says. “Another member of that group, Rabbi Jordi Gendra-Molina, also the descendant of hidden Jews, has a role in telling the story in ‘A Long Journey.’ ”
Charlie Carrillo was among those who sat down to talk about his life for the documentary. A month after production ended, he suffered a massive heart attack and stroke.
Today, he’s on the mend at his house in Abiquiú, where’s he’s been social distancing since before March.
“My doctor’s told me that I had to stay away from people,” he says. “We have a nice home up here, and it’s where I can still be creative.”
Carrillo is a nationally recognized santero, specializing in carved Catholic saints and painted wood retablos.
While working on his Ph.D. in anthropology, he discovered his Jewish roots and embarked on a journey of self-discovery.
This led to the incorporation of Jewish themes and iconography in his creative work.
“The point I was trying to make in the film is that many of us have that ancestry,” he says. “We recognize that’s our ancestry. But I claim to my Catholic faith. My message is that I understand it’s part of my ancestry. I embrace it only to the degree that I recognize. I chose to remain Catholic.”
A devout Catholic, he’s also a Penitente.
Carrillo says he does incorporate Jewish symbols and images with Old Testament figures.
“It relates to the Jewish faith,” he says. “Since finding out about my ancestry, I’ve been invited to Congregation Nahalat Shalom to do shows there where I was the only artist.”
Unlike Carrillo, upon learning of his Sephardic ancestry, Tim Herrera began a plan to make his way back to Israel.
The La Jara resident is featured in the documentary going on a visit with a cousin who discusses the meaning of the small rocks placed on top of the graves of relatives (an ancient Jewish custom).
There had been moments in his life when he wondered where certain traditions came from.
“It was butchering,” he recalls. “I remember my grandpa and my dad. We were butchering our own beef and he turned around to grab the knife. He wanted to cut the throat before the meat went bad. I always thought you would ruin the meat if you waited too long.”
When Herrera joined the military, he had an opportunity to know people from all over the world.
That’s when he realized that what his grandfather and dad were saying was wrapped up in Jewish tradition.
Herrera says people often ask him why he chose Israel instead of Spain.
“I want to go back home and let it come full circle,” he says. “We’ve put our paperwork in, and it got denied. We’re looking at the next step to continue this journey.”
Copyright © 2020 The Washington Times, LLC.
Author: The Washington Times http://www.washingtontimes.com
Do Not Ignore Covid-19 Safety This Thanksgiving
TORONTO, ON – Charities in Toronto are making special arrangements, including setting up takeouy … [+] style service in perparation for Thanksgiving in Toronto. October 8, 2020 (Steve Russell/Toronto Star via Getty Images)
After months of isolation and quarantine, many hoped that Covid-19 would be under control by the holiday season so families could reunite. As Thanksgiving approaches, that hope feels like a distant memory as daily cases reach record highs in the United States. Caution must hold precedence over anything else as families question whether to gather in the coming weeks. We must set aside traditions for everyone’s safety.
November of 2019 may seem like a lifetime ago, but examining the traditional thanksgiving dinner of yesteryear exposes the dangers such an event could hold in a pandemic. Events may range from ten to twenty or more family members. Caution lights should already be going off in your head. Avoiding large gatherings is one of the keys to fighting against the viral spread. Gathering a couple dozen family members in a single location exacerbates the danger of contraction for all in attendance.
Of those couple dozen, odds are that many of them are from out-of-town. In 2019, 55.3 million Americans traveled for Thanksgiving. Midwestern states like Iowa, Wisconsin, Illinois, etc. are experiencing positive case rates of nearly one hundred per hundred thousand, or more than double the national average. A cousin from Iowa visiting a family in Vermont puts the Vermonters at enormous risk. Traveling by train, car, and bus can also expose the traveler to a risk of infection. Visitors from just the town over can be just as dangerous as the cousin traveling across the country. This helpful map demonstrates the risk of large gatherings by county. Avoid having visitors from counties in red, to be blunt.
The greatest risk is the main indoor activity: eating and sharing the same indoor space. The virus spreads through droplets and aerosols in the air that we release when we cough, sneeze, talk, or even breathe. This is why masks are effective; they block these droplets from spreading. This is why restaurants and bars are Covid-19 infection hotspots. People cannot wear masks when eating and drinking. Hosting a Thanksgiving get-together is akin to eating at a downtown restaurant, which several states and countries recommend against or even ban.
Besides N95s, most masks do not even stop aerosols, which may hang in the air of poorly ventilated indoor spaces for hours. Masks also do not stop infection through the eyes via droplets or aerosols. The virus is also transmitted by touching surfaces on which droplets have landed and then touching the mouth, nose, or eyes before washing your hands. The risks of even a masked Thanksgiving event are still present and significant.
A new national survey from the Ohio State University Wexner Medical Center finds that many are planning to recognize these risks and take necessary precautions in the coming weeks. Unfortunately, two in five Americans report they will attend a gathering of more than ten people and one in three will not ask guests to wear masks. This fraction of Thanksgiving celebrations will further Covid-19 transmission across the country. If someone in your household plans to attend one of these events, please convince them otherwise.
Outside skipping the holiday this year altogether, public health experts recommend families keep it quaint this year. Limit attendance as much as possible; convince out-of-town folks to stay home; wear masks as much as possible; and remain outside. The CDC has released holiday guidelines for those keeping their gathering Covid-19 safe. Taking precautions does not mean be sad and lonely this holiday season. Spend time with those in your household; hold a virtual Thanksgiving with friends and family; reminisce on the time before Covid-19 and dream about the time after.
The harsh reality of Covid-19 is that things are only going to get worse in the immediate future. A vaccine will not be available for months. Public health experts theorize that colder temperatures will force people inside closed spaces, where the virus spreads more effectively. Europe is headed back into lockdown to get their cases under control. The dangers are simply too high to be hosting large scale get-togethers centered around eating.
Safety and caution this holiday season will help everyone return to normal for the next holiday season. Everyone is struggling to cope with isolation and loneliness. Despite the virus separating us, we are all together in the fight to defeat it. For this Thanksgiving: stay home, stay safe, and next Thanksgiving will be all the better.
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Author: William A. Haseltine