Cook Medical recalls select Zenith Alpha endo grafts
The FDA today released information on a recall of Cook Medical’s Zenith Alpha thoracic endovascular graft designed for treating blunt traumatic aortic injury over issues with thrombus formation, classifying the recall as Class I. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Zenith Alpha thoracic endovascular graft is designed to treat isolated lesions in main blood vessels that carry blood from the heart through the chest into the abdomen, and is used in...
Source: Mass Device - August 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Recalls Vascular Cook Medical Source Type: news
An ocean away: Care for laryngeal cleft brings Clara to Boston
My husband, Duncan, and I were living in London, England, when Clara was born. Although my pregnancy had started out like any other, I later developed severe polyhydramnios, an accumulation of amniotic fluid that can sometimes indicate the presence of certain congenital issues. After I delivered, it became clear that Clara had a congenital condition called esophageal atresia with tracheoesophageal fistula (EA/TEF). This condition meant that her esophagus (the tube that carries food from the mouth to the stomach) hadn’t developed properly and didn’t connect to her stomach, but that her esophagus and windpipe wer...
Source: Thrive, Children's Hospital Boston - July 11, 2017 Category: Pediatrics Authors: Natascha Kiernan Tags: Diseases & Conditions Our Patients’ Stories Center for Airway Disorders Dr. Reza Rahbar laryngeal cleft Source Type: news
Real Stories Of Americans Who Will Be Affected By The Proposed Changes To The ACA — And What YOU Can Do To Fight
With the proposed changes to the Affordable Care Act (ACA), 20 million Americans are at risk of losing their health care coverage. A survey, conducted by Brunswick Partners, found that “75 percent of Americans agree that the proposed changes to Medicaid in the AHCA are a bad idea. And that we should not allow 14 million Americans to become uninsured even if there is a potential to reduce Medicaid spending. These results are significant because they find majorities of Americans identifying as conservatives (55 percent), moderates (82 percent) and liberals (90 percent) are opposed to the AHCA’s Medicaid pro...
Source: Healthy Living - The Huffington Post - June 21, 2017 Category: Consumer Health News Source Type: news
FDA approval granted to pediatric device used to treat esophageal birth defect
(University of Chicago Medical Center) The US Food and Drug Administration has granted authorization for a magnetic device used to treat pediatric esophageal atresia, a birth defect that causes abnormal formation of the esophagus. The Flourish Pediatric Esophageal Atresia device was created by University of Chicago Medicine assistant professor of radiology Mario Zaritzky, MD, in collaboration with Cook Medical. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 25, 2017 Category: International Medicine & Public Health Source Type: news
MassDevice.com +5 | The top 5 medtech stories for May 15, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. HRS 2017 Roundup: Study pinpoints battery issue in Abbott’s Nanostim leadless pacer A study of the Nanostim leadless pacemaker Abbott acquired this year when it bought St. Jude Medical, presented last week at the annual H...
Source: Mass Device - May 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Cook Medical wins FDA nod for Flourish pediatric surgery device
Cook Medical won FDA approval for its Flourish pediatric esophageal atresia anastomosis device, which is designed to treat infants with a birth defect that causes a gap in the esophagus. Babies born with esophageal atresia cannot feed normally and need a feeding tube until surgery is performed to attach the esophagus to the stomach. The device, which is the 1st of its kind, uses magnets to pull the upper and lower esophagus together, closing the gap. It is not indicated for use in infants who have an abnormal connection between the esophagus and windpipe, also known as a tracheoesophageal fistula. “This new device pr...
Source: Mass Device - May 15, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Regulatory/Compliance Surgical Wall Street Beat Cook Medical Source Type: news
New Device Approved for Esophageal Birth Defect
MONDAY, May 15, 2017 -- A new medical device has been approved by the U.S. Food and Drug Administration to treat esophageal atresia, a birth defect that causes a gap between the esophagus and stomach. One of 2,500 babies in the United States is... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - May 15, 2017 Category: General Medicine Source Type: news
FDA Clears First-of-Its-Kind Device for Esophageal Atresia FDA Clears First-of-Its-Kind Device for Esophageal Atresia
The Flourish Pediatric Esophageal Atresia Anastomosis device uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 12, 2017 Category: Consumer Health News Tags: Pediatrics News Alert Source Type: news
FDA authorizes use of new device to treat esophageal birth defect in babies
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 12, 2017 Category: American Health Source Type: news
FDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies
May 12, 2017 -- The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 12, 2017 Category: Pharmaceuticals Source Type: news
A salute to Noah’s heroes
Noah Hamm has escaped death more times than his mother Danielle can count. And he’s only 3. Since Noah was born there have been three constants in his life: Noah’s knack for near misses, his family and a neonatologist/pulmonologist who’s always there with the right care for Noah … and the right words for his family. “I tell Larry [Dr. Larry Rhein] he’s our George Bailey,” says Noah’s mom Danielle DiBenedetto. Larry gave me hope. Even when things were bad, I always felt better when Larry was there. Noah was a 29-week twin when Danielle’s water broke prematurely. “...
Source: Thrive, Children's Hospital Boston - May 25, 2016 Category: Pediatrics Authors: Lisa Fratt Tags: Diseases & Conditions Our Patients’ Stories Dr. Anne Hansen Dr. Larry Rhein Dr. Reza Rahbar Dr. Terry Buchmiller esophageal atresia laryngeal cleft patent ductus arteriosus tracheoesophageal fistula Source Type: news
Minimally Invasive Surgery in Neonatal Patients: A Review
Laparoscopic and thoracoscopic surgery have gradually become accepted diagnostic and therapeutic modalities in the management of neonatal surgical conditions. In the hands of experienced surgeons, minimally invasive surgery (MIS) has reduced the need for open procedures. In children younger than 1 year, the advantages of MIS are evident in avoiding the sequelae of open surgery. MIS has shown outcomes comparable to those with open surgery. The recent literature in the PubMed database was reviewed, using the keywords "minimally invasive surgery," "neonatology," "pediatric surgery," "laparos...
Source: NeoReviews recent issues - May 1, 2016 Category: Pediatrics Authors: Lopez, J., Stringel, G. Tags: Pediatric Drug Labeling Update Articles Source Type: news
Marissa’s story: “Esophageal atresia is never going to define me”
Marissa Waite lives in the smallest town in Massachusetts, but she has a big story to tell. When her mother Vicky was pregnant with Marissa 13 years ago, an ultrasound detected esophageal atresia (EA), a condition where the esophagus isn’t connected to the stomach. Vicky was admitted to Brigham and Women’s Hospital for the remainder of her pregnancy. “I’m a take-charge kind of person. When I was pregnant, I thought, ‘I’ll make all the decisions for my baby.’ But when complications arose, I realized I couldn’t make these kinds of decisions alone,” she says. At that point...
Source: Thrive, Children's Hospital Boston - August 13, 2015 Category: Pediatrics Authors: Jenny Fernandez Tags: All posts Our patients’ stories esophageal atresia GERD Steven Fishman VSD Wayne Tworetzky Source Type: news
Meet Ryan: The boy who grew his own esophagus
Dr. Rusty Jennings, Ryan Page, Dr. John Foker Eleven-year-old Ryan Page is a budding trombone player whose favorite foods include candy, popcorn and hot dogs. “Ryan loves any choking hazard,” jokes his mother Tracy. When Ryan was born, few would have predicted he would be able tolerate these foods or master the trombone. “His doctors told us he had the longest gap they had ever seen in a baby with esophageal atresia,” recalls Tracy. Ryan was born with a nearly 4-inch gap between the top and bottom parts of his esophagus. “This is a kid whose predestination based on standard therapy was chronic...
Source: Thrive, Children's Hospital Boston - July 17, 2015 Category: Pediatrics Authors: Lisa Fratt Tags: Our patients’ stories Advanced Fetal Care Center Dr. John Foker Dr. Rusty Jennings esophageal atresia Esophageal Atresia Treatment Center G-tube Source Type: news
Baby with rare condition that made milk shoot out of her NOSE is cured
Georgie Yorke, eight months, from Consett, County Durham, was born with birth defect oesophageal atresia, meaning her feeding tube was not connected to her stomach. (Source: the Mail online | Health)
Source: the Mail online | Health - March 2, 2015 Category: Consumer Health News Source Type: news
Baby Everly blossoms after esophageal atresia surgery
Baby Everly, born weighing a fragile 4 pounds 2 ounces, was diagnosed with the rare birth defect called long gap esophageal atresia (EA)—a condition where part of her esophagus, the tube connecting her mouth to her stomach, was missing. In need of specialized pediatric care for their daughter, Everly’s parents brought her to Boston Children’s Hospital where Russell “Rusty” Jennings, MD, co-director of the hospital’s Esophageal Advanced Treatment Center, and a team of clinicians successfully repaired her esophagus. Today, baby Everly is hitting all of her milestones—eating solid foo...
Source: Thrive, Children's Hospital Boston - January 16, 2015 Category: Pediatrics Authors: Maureen McCarthy Tags: Our patients’ stories Source Type: news
What Causes Abdominal Distention?
Discussion Constipation generally is defined as infrequent or painful defecation. It often is due to passing large hard stool infrequently which causes painful defecation and then withholding behaviors. As stool withholding continues, the rectum dilates and gradually accommodates with the normal defecation urge disappearing. Chronic rectal distension results in both loss of rectal sensitivity, and loss of urge to defecate, which can lead to encopresis. Abdominal distention because of stool retention occurs frequently. Treatment includes colonic evacuation, establishing regular bowel habits, eating a balanced diet with diet...
Source: PediatricEducation.org - July 21, 2014 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
A home for Lucy
Lucy's feeding time For a 18-month-old girl, Lucy Schurman has very grownup tastes. It’s a cold, blustery December evening in Brookline, Mass., and the precocious toddler sits in a bright yellow child seat in a spacious, warmly lit kitchen, eating chunks of avocado. “Chili is her favorite food,” her mother Jeana comments to Pam Lodish, who is tending to food on the stove. “But she’ll eat almost anything, kalamata olives or grapefruit. She even loves curry and handles spicier stuff better than her dad.” As Lucy eats, a playful Bernese mountain dog saddles up beside her and the two en...
Source: Thrive, Children's Hospital Boston - March 7, 2014 Category: Pediatrics Authors: Kipaya Kapiga Tags: All posts our patients' stories Parenting Source Type: news
Parents’ Night Out: A welcome break from hospital life
By Kipaya Kapiga While Boston may be well-known for its great cuisine, the last thing a family traveling to Boston Children’s Hospital for long-term treatment is thinking about is fine dining. When parents care for a sick child in the hospital, it can be difficult for them to leave their child’s bedside to catch some sleep, let alone to take in the local fare. For more than a year, however, Boston Children’s has been working to change that by bringing the downtown Boston dining experience into the hospital. Parents’ Night Out is a monthly dinner event for the parents whose children have a long-term...
Source: Thrive, Children's Hospital Boston - May 22, 2013 Category: Pediatrics Authors: Guest Blogger Tags: All posts Our patients’ stories Parenting child life our patients' stories stress relief when caring for a sick child Source Type: news