Carag Receives U.S. FDA IDE Approval to Conduct Clinical Study of First Transcatheter Septal Occluder With Bioresorbable, Metal-free Framework
The U.S. trial for CE-marked CBSO is designed to enroll up to 250 patients in a staged study approach BAAR, Switzerland, July 1, 2020 -- (Healthcare Sales & Marketing Network) -- CARAG AG, a privately-held Swiss medical device development company, toda... Devices, Interventional, Cardiology, FDA Carag AG, Carag Bioresorbable Septal Occluder, atrial septal defects (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 1, 2020 Category: Pharmaceuticals Source Type: news
What Causes Bradycardia?
Discussion Bradycardia is a heart rate below what the lowest value that is normal for age. Infants and children have higher heart rates that slowly decrease with age to adult levels. It is usually noted as an incidental finding because of increased vagal tone. Reasons for cardiology referral include associated heart murmur, syncope especially if associated with exercise or unusual triggers, other signs such as chest pain or palpitations, family history of sudden cardiac death, congenital heart disease or familial heart disease, bradycardic medication use, or unusual symptoms associated with the concern. Severe bradycardia ...
Source: PediatricEducation.org - June 22, 2020 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news
GORE(R) CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects
Data from the Gore ASSURED Clinical Study demonstrated 100 percent closure success at six months FLAGSTAFF, Ariz., June 4, 2019 -- (Healthcare Sales & Marketing Network) -- W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration'... Devices, Interventional, Cardiology, FDA W. L. Gore, patent foramen ovale, CARDIOFORM, Septal Occluder (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 4, 2019 Category: Pharmaceuticals Source Type: news
Gore Takes on Abbott with New PFO Stroke Indication
W.L. Gore & Associates has received FDA approval to expand the indication of the Gore Cardioform Septal Occluder to reduce the risk of recurrent ischemic stroke in patients. The device treats patients through the closure of patent foramen ovale (PFO). Cardioform’s previous indication was for the closure of atrial septal defects that are up to 17mm in size. Gore’s Structural Heart Leader, Jake Goble said Cardioform has the potential to redefine stroke prevention. Goble began working for Gore in 2007. It was around that time the company began to explore the possibility of having the Cardioform focus on stroke...
Source: MDDI - April 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts. The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects. “It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news
Experience Journal: Coping with a child ’s congenital heart disease
At 16 months old, Avery was diagnosed with an atrial septal defect — a hole in the wall between the heart’s upper chambers that required open-heart surgery to repair. Shock, fear and pride were just a few of the emotions Avery’s parents Jessica and Andrew experienced throughout their journey coping with their daughter’s congenital heart defect (CHD). The couple found it helpful to talk through their questions and feelings with other parents of children with a CHD, as well as with Avery’s caregivers from the Heart Center at Boston Children’s Hospital. Now with...
Source: Thrive, Children's Hospital Boston - February 27, 2017 Category: Pediatrics Authors: Jenny Fernandez Tags: Diseases & Conditions Our Patients’ Stories atrial septal defect Dr. Pedro del Nido Experience Journal Heart Center Source Type: news
Hands On Product Reviews January 2017
Improved Manikin Control Graphical user interface changed the way we interact with computers. Since the introduction of the Macintosh in 1984, all computers have become more intuitive and require less knowledge of computer code for the everyday user. Continuing the trend of easy use, the new SimPad Plus from Laerdal has increased the processor speed, improved WiFi connectivity and added a Bluetooth connection to increase the number of manikins the SimPad Plus can control. Running scenarios with manikins or standardized patients remains intuitive and allows the instructor to be in the room or in a vehicle throughout the sim...
Source: JEMS Operations - December 30, 2016 Category: Emergency Medicine Authors: Fran Hildwine, BS, NREMT-P Tags: Columns Equipment & Gear Source Type: news
Making heart surgery as simple as possible with MIS techniques
Tertiary care centers such as the Boston Children’s Hospital Heart Center have led the way in groundbreaking surgical innovations for years, pushing boundaries and correcting ever more complex abnormalities. But innovation is also making a difference when it comes to more “common” procedures. “We’re always trying to make the less complex procedures shorter and less invasive,” says Sitaram Emani, MD, director of the Complex Biventricular Repair Program at the Heart Center. “Making surgery and recovery less painful and disruptive for all of our patients is a priority.” Emani a...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Vector Blog Source Type: news
CorMatrix launches Tyke cardiac tissue repair device for neonates
CorMatrix Cardiovascular said today it launched its CorMatrix Tyke cardiac tissue repair patch designed for correcting congenital heart defects in neonates and infants, touting the 1st successful procedures utilizing the patch. The CorMatrix Tyke is a patch designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing. “We are excited to partner with our pediatric cardiac surgeons to deliver Tyke as product developed to address a specific need in the neonatal and infant population. CorMatrix Tyke is one of the few prod...
Source: Mass Device - June 21, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regenerative Medicine CorMatrix Cardiovascular Inc. Source Type: news
Life with congenital heart disease: Looking back with gratitude, looking ahead with hope
Jennifer D’Ercole McKenna, 49, is a patient pioneer — part of a small but growing group of middle-age adults with congenital heart disease who had surgical repair in infancy or early childhood. “It’s hard for doctors to answer questions about how long I’m going to live. I ask, ‘Will I live until my 80s?’ and their response is, ‘That’s our goal.’” In 1966, the average life expectancy for someone with Jennifer’s diagnosis, Ebstein’s anomaly, was 37 years (39 for females and 33 for males). Jennifer shares her lifetime of wisdom with parents and...
Source: Thrive, Children's Hospital Boston - June 1, 2016 Category: Pediatrics Authors: Erin Horan Tags: Our Patients’ Stories BACH congenital heart disease Dr. Keri Shafer Dr. Michael Landzberg Dr. Sitaram Emani Source Type: news
Experience Journal: Growing up with congenital heart disease
One in 100 babies is born with some form of congenital heart defect (CHD). Sometimes the issue is minor and doesn’t cause serious problems. Other times, the heart can’t function properly and needs immediate, invasive surgery. As kids with CHD grow up, they learn their condition will follow them for life and need continued attention. Every CHD heart is unique, but some experiences are universal, and kids and families can help support one another through challenging times. The Heart Experience Journal, created by the Department of Psychiatry and the Heart Center, represents the “collective wisdo...
Source: Thrive, Children's Hospital Boston - February 18, 2016 Category: Pediatrics Authors: Erin Horan Tags: Experience Journal atrial septal defect congenital heart defect congenital heart disease Heart Center Source Type: news
CorMatrix wins FDA nod for Tyke neonate cardiac tissue
CorMatrix Cardiovascular said today it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants. The patch is designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing. The Tyke is derived from the company’s ECM technology platform and is composed of 2 layers of ECM, as opposed to 4 layers in their standard cardiac tissue repair patches, making it thinner for smaller repairs. “FDA clearance further validates CorMatrix ECM technology for creating world class implantable cardiac devices. Cor...
Source: Mass Device - February 9, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Clearance CorMatrix Cardiovascular Inc. Source Type: news
The marathon of life: Catching up with Greek army lieutenant, 31 years post heart surgery
Ted Sarafis ran the Athens Marathon 30 years after life-saving surgery to close a hole in his heart Well into his teenage years, Greek army lieutenant Thodoris (Ted) Sarafis thought the scar on his chest was the result of an unfortunate tumble he took as a child. “My parents told me I had an accident, and that’s where I got my scar,” he says. Sarafis didn’t learn he’d had heart surgery as a toddler until his medical clearance exam for the Greek national karate team at age 16. Ted took the news in stride, but last year, curiosity got the better of him, and he pressed his father for more informa...
Source: Thrive, Children's Hospital Boston - January 6, 2016 Category: Pediatrics Authors: Erin Horan Tags: Diseases & Conditions Our Patients’ Stories atrial septal defect cardiac surgery congenital heart disease Heart Center Source Type: news
This month’s most missed USMLE question--and the right answer
As you prepare for the United States Medical Licensing Exam® (USMLE®), do you know which questions to look out for? We’re giving you an exclusive scoop on the most challenging USMLE test prep questions and expert strategies to help you beat them. Find out what this month’s toughest question is and receive an expert video explanation of the answer from Kaplan Medical. Welcome to the third post in AMA Wire’s® series, “Tutor talk: Tips from Kaplan Medical on the most missed USMLE test prep questions.” Each month, we’re revealing one of the top questions stu...
Source: AMA Wire - November 25, 2015 Category: Journals (General) Authors: Troy Parks Source Type: news
CANOA: Clopidogrel Reduces Migraine After ASD ClosureCANOA: Clopidogrel Reduces Migraine After ASD Closure
The study provides definitive data that dual antiplatelet therapy leads to fewer migraines after transcatheter closure of an atrial septal defect, the lead author says. Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 10, 2015 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
Brave Hearts: How one Mom faces her daughter’s congenital heart disease
Finding out your child has congenital heart disease (CHD) can send you on an emotional roller coaster. “You can’t help but think, is this my fault? What did I do wrong?” says Jessica Nigrelli, whose daughter Avery was diagnosed with CHD when she was 16 months old. When Avery was a baby, she had an on-again, off-again heart murmur that was checked every three months. When the murmur persisted at 16 months, her primary care doctor recommended she see a cardiologist from Boston Children’s Hospital. At the Heart Center’s outpatient clinic in Waltham, Dr. Susan Saleeb discovered Avery’s atria...
Source: Thrive, Children's Hospital Boston - July 28, 2015 Category: Pediatrics Authors: Erin Horan Tags: Heart conditions cardiac surgery congenital heart disease Heart Center Source Type: news
Congenital heart disease is no match for this fighter
It’s a Saturday afternoon at Fist Fitness, a boxing gym in Westford, Mass. co-owned by Joe Bellone and Sean Eklund, nephew of the famous “Irish Micky Ward.” A patron enters, slightly tired from a morning 5K run, but ready for another solid workout. It’s been a few months since she’s trained at the gym, but she remembers all of the motions: left, right, 1-2-3, uppercut–she’s in the zone. Her trainer, Eklund, kneels down to get to her eye level. Twelve-year old Hayden is just under 54” tall. Hayden Schenck is not your average sixth grader. She has a zest for adventure, a love o...
Source: Thrive, Children's Hospital Boston - June 22, 2015 Category: Pediatrics Authors: Erin Horan Tags: Our patients’ stories congenital heart defect congenital heart disease Heart Center Source Type: news
Kristin’s story: From open heart surgery patient to child life specialist
There’s a saying: “Life’s roughest storms prove the strength in our anchors.” I have faced many storms in my life, and my anchors have grounded me with hope and strength. I was born with complex congenital heart disease. By the time I was 36 hours old, I had been diagnosed with an atrial septal defect (ASD), ventricular septal defect (VSD), double outlet right ventricle, left and right ventricles reversed, dextracardia, mitral valve regurgitation and pulmonary stenosis. For many, this sounds like a long laundry list of defects, but for me and my family it became everyday life. At 10 days old, ...
Source: Thrive, Children's Hospital Boston - February 24, 2015 Category: Pediatrics Authors: Guest Blogger Tags: Heart conditions Our patients’ stories congenital heart disease Heart Center Source Type: news
Joey’s message of hope: Listen to your heart
Five minutes. That’s how long Joey Williams was expected to live – IF he made it to term, which his doctors were not expecting. His mother, Rebecca Williams, received the prognosis when she was 21 weeks pregnant. Prenatal testing had already revealed that Joey had Down syndrome and a significant type of congenital heart disease in which one of the sides of his heart was underdeveloped. His diagnoses included atrial septal defect and ventricular septal defect. When Rebecca heard the news of her son’s meager life expectancy, she was devastated. Yet she also felt a well of unconditional love grow ...
Source: Thrive, Children's Hospital Boston - February 9, 2015 Category: Pediatrics Authors: Erin Horan Tags: Heart conditions Our patients’ stories Source Type: news
Blunt chest trauma resulting in both atrial and ventricular septal defects - Ortiz Y, Waldman AJ, Bott JN, Carlan SJ, Madruga M.
Cardiac septal defects are known complications to blunt chest trauma. The incidence of a traumatic isolated atrial septal defect is unknown and the concurrent occurrence of nonlethal ventricular and atrial septal defects has not been reported. A healthy ma... (Source: SafetyLit: All (Unduplicated))
Source: SafetyLit: All (Unduplicated) - October 24, 2014 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
A Parent’s View: The Importance of Children’s Hospitals
This story is written by Kerri Vatour and was originally published on the Children’s Hospital Association’s blog. The first time Boston Children’s Hospital saved my son’s life, he was 21 hours old. It wasn’t a surprise—Joey had been diagnosed in utero with both a ventricular septal defect (VSD), a hole between the right and left sides of his heart, and a duodenal stenosis, where a portion of the intestine is so constricted that very little can pass through, by doctors in the Advanced Fetal Care Center. Upon birth, it was obvious that the latter issue would take precedence, and Dr. Smithe...
Source: Thrive, Children's Hospital Boston - August 21, 2014 Category: Pediatrics Authors: Guest Blogger Tags: All posts Source Type: news
Nigeria: Breaking Hearts - Can Nigeria Lay Claim to Breakthrough Surgeries
[Daily Trust]L was his name, and his heart was broken. Doctors call it atrial septal defect (ASD)--literally, a hole in his heart. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - May 28, 2014 Category: African Health Source Type: news
Nigeria: Breaking Hearts - Can Nigeria Lay Claim to Breakthrough Surgeries?
[Daily Trust]His name was simply L and his heart was broken. Doctors call it atrial septal defect (ASD)--literally, a hole in his heart. And the surgery to fix the hole is becoming less breakthrough and more routine. It held not in India, Germany or Saudi Arabia, but in a sterile theatre at Garki Hospital in Abuja. The surgeons weren't foreign, with countless heart surgeries under their belt. They were Nigerian surgeons--with names like Miner, Okereke, Sanusi--backed by anaesthesists, scrub nurses, all hovering over L' (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - May 26, 2014 Category: African Health Source Type: news
What Are Indications for Pediatric Pacemakers?
Discussion More pediatric patients are having cardiac pacemakers and implantable cardioverter defibrillators (ICDs) placed because the devices are becoming smaller and are technically feasible plus the surgical complexity of patients also keeps increasing. Pacemakers have an impulse generator and leads. The leads can be placed uni- or bilaterally and are attached to the endo- or epicardium. The generator is placed in the left pectoral area. Complications include lead dislodgement or breakage, and inappropriate shocks. Other problems include need for lead or generator revisions, lifestyle modifications, and cosmetic changes...
Source: PediatricEducation.org - July 7, 2013 Category: Pediatrics Authors: Donna M. D'Alessandro, M.D. Tags: Uncategorized Source Type: news
Our patients’ stories: saving “princess” Emily
By Paul Schuster Emily Our daughter Emily’s heart defect wasn’t discovered until she was nearly 3 years old. In hindsight, we now know that her numerous illnesses and bouts of pneumonia were a sign that something wasn’t right, but until her diagnosis, we never suspected anything serious. She always had plenty of liveliness and certainly kept us busy with her antics—dancing or singing or getting Daddy to play princess with her… again. By all counts, she was just our happy, energetic little girl. Then, during a routine doctor’s visit, a nurse said she heard a murmur in Emily’s ...
Source: Thrive, Children's Hospital Boston - June 28, 2013 Category: Pediatrics Authors: Guest Blogger Tags: All posts Heart conditions Our patients’ stories ASD atrial septal defects Christopher Baird David Fulton Heart Center Jenna Murray our patients' stories Source Type: news
Heart Defect Closure Rate Increasing (CME/CE)
ORLANDO (MedPage Today) -- The number of procedures performed to close an atrial septal defect or patent foramen ovale has increased in recent years, while length of stay associated with the procedure has dropped, researchers found. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 9, 2013 Category: Cardiology Source Type: news
Our patients’ stories: Hunter’s heart journey
By Wendy Paulin Hunter as a baby As a parent, when you look at your newborn, it’s hard not to get swept up by all the possibilities that lie ahead. Your child has the world ahead of him—you can’t help but wonder what life’s adventures have in store. That feeling of unlimited potential is why Dr. Seuss’s, “Oh, the Places You’ll Go” is such a big hit in our family, both for my four boys and myself. But when I read “Oh, the Places You’ll Go” to my youngest son, Hunter, the words took on a whole new meaning. As I read him the story and shared the bright, be...
Source: Thrive, Children's Hospital Boston - April 9, 2013 Category: Pediatrics Authors: Guest Blogger Tags: All posts Children's in the news Heart conditions Our patients’ stories Heart Center Jim Lock our patients' stories Pedro del Nido Source Type: news
Our patients’ stories: fixing Brody’s omphalocele
By Maureen Simoncini Brody When I was 18 weeks pregnant my husband, Kenny, and I went in for a routine ultrasound. We were excited to find out if I was carrying a boy or a girl, but we found out much more than that. The ultrasound revealed that I was having a boy, but he would be born with a serious medical condition called an omphalocele. (It’s a birth defect where the baby’s intestine or other organs stick out of the belly button. In many cases only a thin layer of tissue covers the intestines.) Once it was established that our baby had an omphalocele, we were transferred to a doctor at our local hospita...
Source: Thrive, Children's Hospital Boston - March 22, 2013 Category: Pediatrics Authors: Guest Blogger Tags: All posts Diseases & conditions Our patients’ stories omphalocele our patients' stories surgery Terry Buchmiller Source Type: news