This June 18, 2019 photo provided by the Cleveland Clinic
Cleveland Clinic in Ohio becomes the first hospital in North America to deliver a baby born out of uterus that was transplanted after the donor was deceased.
The mother, who is in her mid-30s, is part of a groundbreaking research trial involving 10 women with uterine factor infertility, who are all destined to receive uterus from deceased donors. Since the start of the trial, the team has performed 5 uterine transplants, of which 3 were successful, including the one which resulted in a live birth. Two other women are waiting for embryo transfer.
The baby was delivered “en caul,” meaning the amniotic sac remained intact until after the delivery. This is an extremely rare but safe occurrence and happened spontaneously with this delivery, adding to the special occasion. The woman whose identity was not disclosed chose to remove the uterus after delivering the baby.
This is the second birth from a uterus from a deceased donor, the first occurred in 2017 in a Brazilian trial involving a 32-year-old woman born without a womb who received a uterine transplant from a 45-year-old woman who'd died of a stroke.
Here is the video from Cleveland Clinic
First Baby Delivered in North America Using a Uterus Transplanted from Deceased Donor - YouTube
The U.S. Food and Drug Administration (FDA) granted a Breakthrough Device Designation for the Advanced Prenatal Therapeutics, Inc. (APT) Targeted Apheresis Column for Preeclampsia (TAC-PE) in the treatment of preeclampsia.
Currently, the therapeutic options for preeclampsia are limited and include bed rest, anti-hypertensive medications and induction of preterm labor if needed.
The TAC-PE column is an apheresis device that works like kidney dialysis in selectively removing the harmful substances from the blood. While the exact cause of preeclampsia is not known, several biomarkers have been identified that are responsible for life-threatening preeclampsia symptoms like kidney and liver dysfunction and high blood pressure.
The apheresis procedure resembles voluntary blood donation. The woman’s blood is pumped through the apheresis machine to separate it into plasma and blood cells. The plasma then passes through the TAC-PE device, where the toxic substances are captured. The toxin-free plasma is mixed with the cells and returned to the patient.
APT first therapeutic target is soluble fms-like tyrosine kinase-1 (sFlt-1). The circulating sFlt-1is made by the placenta and antagonizes the action of Vascular endothelial growth factor (VEGF), that triggers new vessel formation and vasodilatation in normal pregnancies. Pre-eclampsia occurs when the relative functional activity sFlt-1 exceeds that of VEGF resulting in vasoconstriction in important organs like kidney, liver, and brain (the organs most affected by preeclampsia).
Removal of sFlt-1 from blood helps to restore the vascular homeostasis by alleviating the endothelial dysfunction. This eliminates the need for premature termination of pregnancy, helps stabilize the mother and baby to let the pregnancy proceed naturally to term.
“We were navigating virtually uncharted waters in 2005 when we first proposed that preeclampsia could be treated using an apheresis column to remove pathogenic factors such as sFlt-1,” said Dr. James Smith, President/CEO of APT. “Now that we are preparing for initial clinical studies, we are very pleased that the Breakthrough Designation will help provide a clear and efficient pathway to market.”
APT is a Laguna Hills, California based company involved in developing an effective treatment that will safely prolong pregnancy, allowing babies more time to develop in the womb in patients with preeclampsia.
The US Food and Drug Administration (FDA) recently approved bremelanotide (Vyleesi, AMAG Pharmaceuticals), for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
Vyleesi, a melanocortin receptor agonist that comes as autoinjector, joins flibanserin(Addyi, Sprout Pharmaceuticals) as the class of drugs approved by the FDA for the treatment of acquired HSDD. Flibanserin is Serotonin 5-HT-Receptor Agonists and is taken orally.
HSDD is the most commonly prevalent female sexual dysfunction and is largely under-recognized and undertreated. It is believed that approximately 9% of all premenopausal women in the United States experience it but less than half of these patients seek help or initiate discussions with physicians.
“Women with HSDD often avoid situations that could lead to intimacy, the impact of which goes far beyond the bedroom and can often result in anxiety, loss of vitality, self-esteem issues and relationship stress. It is important that women suffering from this condition have a choice of treatment options available to them,” quote Anita H. Clayton, M.D., Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, VA in an AMAG Pharma news release.
The upside of bremelanotide is women need to use it as required as opposed to flibanserin which must be consumed daily. The drug is dispensed as prefilled autoinjector pen which has to be self-administered by the woman into her abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day.
Courtesy: AMAG Pharmaceuticals
Patients should not use more than one dose within 24 hours or more than eight doses per month. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.
While the exact mechanism of action is still unknown, the drug is believed to act on the melanocortin receptors in the central nervous system that are thought to be associated with sexual function.
The FDA approval of Vyleesi is based upon data from approximately 1,247 women in two pivotal (NCT02333071 and NCT02338960), replicate, double-blind placebo-controlled Phase 3 trials (RECONNECT). Most patients used the drug 2-3 times a month with no more than once a week.
Vyleesi does not enhance sexual performance, but there was a statistically significant increase in desire and decrease in distress at the time of intimacy. Women in both the trials didn’t experience any problem with the autoinjector.
The most common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. An increase in blood pressure was also noted, which usually resolved in 12 hours. Hence, Vyleesi is contraindicated in patients at high risk of cardiovascular disease and those with high-blood pressure.
Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men. AMAG is expected to make Vyleesi commercially available in September 2019 through select specialty pharmacies.
The US Food and Drug Administration (FDA) approved the first-ever diagnostic test to aid in the diagnosis of sexually transmitted Mycoplasma genitalium infection. The Aptima Assay from Hologic Inc, is the only FDA-approved test to detect this under-recognized but increasingly common sexually transmitted infection (STI).
First discovered in the early 1980s, M. genitalium was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015. Currently, it is responsible for causing approximately 15 to 30 percent of persistent or recurrent urethritis cases in men in the United States and 10 to 30 percent of cervicitis cases in women.
This slow-growing pathogen is difficult to detect by traditional laboratory testing methods. In the absence of FDA approved diagnostic test, the STI is often misdiagnosed and treated with wrong antibiotics resulting in persisting infection and widespread transmission.
“Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems,” said Damon Getman, Ph.D., senior principal research scientist and director of research at Hologic in a press release.
The Aptima Assay is a nucleic acid amplification test, which detects M. genitalium in urine samples and urethral, penile meatal, endocervical or vaginal swab collected in a clinical setting, such as a doctor’s office or clinic.
In the clinical study involving 11,774 samples, the Aptima test correctly identified M. gen. in approximately 90 percent of vaginal, male urethral, male urine and penile samples. It also correctly identified the presence of the pathogen in female urine and endocervical samples 77.8 percent and 81.5 percent of the time.
The test also has a high negative predictive value and correctly identified the negative samples 97.8 to 99.6 percent of the time. Vaginal swabs are the preferred samples to perform the test, but urine samples can be used as alternative sample types.
The assay is immediately available at clinical laboratories, physicians and healthcare providers can immediately order the tests by reaching out to the labs. Hologic further anticipates that most insurance plans will cover the testing for M. genitalium.
The Aptima Mycoplasma genitalium Assay was reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type. The FDA exercises special controls over the individual tests approved by the de novo premarket route to ensure the safety and effectiveness of the tests.
The newest M. genitalium assay joins the comprehensive list of men and women’s health assays by Hologic that include sexual and cervical health, and virology testing.
A new Cleveland Clinic study has shown that delaying the first baby bath after delivery increases the breastfeeding rate by 8%, with 49% increased odds of exclusive breastfeeding while in the hospital. These mothers also continued breastfeeding their babies after discharge from the hospital. The odds further increased to 60% if the mother had a vaginal birth versus cesarean birth.
The researchers at Cleveland clinic looked at data from about 1000 mother-newborn couplets in this retrospective, two-group, pre- and postintervention design study. In the intervention group, the first bath was delayed for at least 12 hours vs. following the routine hospital practice of bathing the baby in a couple of hours after birth in the control group.
The demographics were comparable in both the groups. After multivariate regression analysis, it was observed that there was a significant increase in exclusively breastfeeding rates in the study group in whom the bath was delayed for 12 hours.
Why delaying the bath increases the breastfeeding rate is unclear, but researchers behind the study speculate that similarity between the smell of breast and amniotic fluid may better help the baby to latch.
The study adds support to the initiative of establishing immediate skin-to-skin (STS) contact between mother and baby. STS contact has been promoted internationally through the Baby-Friendly Hospital Initiative (BFHI) as a means to improve breastfeeding initiation, exclusivity, and duration after hospital discharge.
“Human touch is vital to the parent and the baby. You need to have that human touch. I think that by not washing the baby (so soon), encouraging skin-to-skin contact and breastfeeding, you’re improving that human touch. So, you’re now looking at a long-term health benefit,” explains Heather DiCioccio, DNP, RNC-MNN, who led the study. The study was published ahead of print inJournal for Obstetrics, Gynecologic, and Neonatal Nursing.
Those babies who received bath after 12 hours were also able to maintain their temperature better as compared to early bathers.
Research has also shown that increased rates of breastfeeding have a wealth of benefits for mother and child in years to come. Risk of childhood and maternal illnesses decrease considerably potentially decreasing the lifetime healthcare costs.
Here is a beautiful video by Cleveland Clinic explaining the findings
Delaying Newborn's First Bath in the Hospital Increases Breastfeeding Success - YouTube
The North American Menopause Society (NAMS) regularly posts comprehensive videos for clinicians about important midlife health topics. All interviews in the series are hosted by NAMS Board of Trustees Member and Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also a medical consultant for CTV News.
In this first video of 2019, Dr. Rebecca Thurston, Director of the Women’s Biobehavioral Health Laboratory and Professor of Psychiatry, Psychology, Epidemiology, and Clinical and Translational Science at the University of Pittsburgh throws some light on the why and how about vasomotor symptoms (VMS).
The natural history of vasomotor symptoms is still evolving. It is estimated that about 75% of women experiencing menopause will have hot flashes. A substantial number of women seen in everyday gynecological practice or specialty menopause clinic report VMS well past the age of 60 and some well into the 80s.
Hot flashes considerably reduce the quality of life and hamper the day to day activities. Prevalence of VMS is generally associated with increased risk of CVD due to endothelial dysfunction. Hence, women with VMS could be screened for CVD risk factor and offered lifestyle modifications and frequent screening for early diagnosis and prevention.
Advances in Our Understanding of the Etiology/Mechanisms of Vasomotor Symptoms - YouTube
Monoclonal antibody romosozumab gains first-ever marketing approval in Japan for the treatment of osteoporosis in patients at high risk of fracture announced Amgen and UCB in a joint press release. The drug will be known as Evenity in Japan and would be developed by Amgen Astellas BioPharma K.K.–a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.
Romosozumab has a dual effect on the bone– it works by binding and inhibiting the activity of the protein sclerostin which increases bone formation and decreases bone breakdown.
Japanese people have the longest life expectancy in the world and with that comes the burden of osteoporotic fractures. In Japan, the osteoporotic fracture is the leading cause of disability that requires long term nursing home care.
"The approval of EVENITY in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen in a news release.
"A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."
The approval is based on results of two phase 3 clinical trials– FRAME and BRIDGE. The FRActure study in postmenopausal woMen with ostEoporosis (FRAME), included 7,180 postmenopausal women with osteoporosis. The women received romosozumab 210 mg s.c. or placebo once monthly for 12 months, followed by denosumab 60 mg s.c. once every 6 months in both groups for 12 months. The drug significantly increased spine and hip BMD and reduced vertebral and clinical fracture risk.
The BRIDGE study (placeBo-contRolled study evaluating the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months. Men on Romosozumab showed a significant bone mineral density (BMD) gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months.
The approval is also significant because FDA rejected Amgen’s initial marketing application for Romosozumab in the US because of cardiovascular side effects of the drug in ARCH trial. The drug is also under regulatory review in Europe.
The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.
Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university's Fujii Memorial Institute of Medical Sciences said in the press release, "Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan."
"Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent," he further added.
Meanwhile, During the second review cycle, the US Food and Drug Administration (FDA) Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) recently voted in favor of approving Amgen and UCB’s romosozumab (EVENITY) In the US for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The committee indicated that the drug benefits for treatment of postmenopausal osteoporosis outweigh its risk.
Will personal ultrasound scanner be readily available and accessible as home glucose or blood pressure monitor? It is possible right now with the Butterfly iQ handheld ultrasound wand and an iPhone– recently showcased at the CES 2019 at Las Vegas.
The new FDA cleared, pocket-sized ultrasound ushers in a new era of medical imaging at a fraction of the cost of large in-office machines. Currently, the FDA clearancecovers 13 clinical applications, the broadest ever for a single ultrasound transducer.
The technology is currently only available for trained medical professionals, but shortly it may be possible to get an ultrasound examination without leaving the comforts of the home. The Butterfly team is beta testing software that can guide patients to capture the scans correctly and share it with respective healthcare providers in real time.
iQ is equipped with the latest Ultrasound-on-Chip technology™, where a single silicon chip replaces the piezo-electric crystals of the traditional ultrasound machines. The 2D array of 9000 programmable micro-machined sensors eliminate the need of linear, curved or phased probes for different parts of body. A single probe can be used to image different systems of the body including Ob/gyn, cardiology, musculoskeletal, and many others. Just slather the probe with gel, and it is possible to switch between different examinations easily.
The probe is compatible with many iPhone models including Apple iOS 11.0 or newer. The built-in battery is optimized for 2 hours continuous scanning or 10-hour shift and can be easily recharged by placing it on the wireless charging base. The iQ device is sleek and housed in an anodized aluminum body to withstand fall or temperature variations,
All the data and images are stored on Butterfly cloud and can be accessed from anywhere at any time. HTTPS, TLS 1.2 and AES 256-bit encryption and monitoring ensure that patient’s scan and personal is protected while at rest and at the time of sharing with the colleagues, peer or health providers. Images can be shared as easily as texting. Just open the image, tag the person and send it as a message.
The Ultrasound comes with deep learning-based artificial intelligence applications tightly coupled to the hardware and helps clinicians with both image acquisition and interpretation. As more and more clinicians use the system, the data acquired to improve the neural network models. This, in turn, will enable the less skilled personnel to capture images correctly.
Priced under $2,000, the Butterfly iQ is currently available for purchase in the US, but it can be reserved for purchase in other countries.
Patients with osteoarthritis (OA) could now delay or avoid knee replacement surgery with the help of a new shock absorbing device that can be implanted alongside the knee joint. The Wexner Medical Center at the Ohio State University becomes the first center in US to implant the CalypsoKnee System to address the pain of the osteoarthritic knee.
Developed by Moximed, a company based in Fremont, California, a prospective, multicentric clinical trial is underway to look at the ability of the device to extend the life of knee joint and enable the patients to lead a pain-free, comfortable life.
The system is put in place under the skin, alongside the medial side of the affected knee through a small incision. The ligaments and bones forming the knee joints are preserved, keeping options open for any future surgical interventions.
With more than 700,000 knee replacement surgeries performed in the U.S. every year, the Calypso Knee System could reverse the trend and delay or avoid the replacement surgery.
Dr. David Flanigan, an orthopedic surgeon at The Ohio State University Wexner Medical Center who performed the surgery said in a news release, “ It works like a shock absorber to take pressure off the inside of the knee while creating a cushion similar to what cartilage provides in a healthy joint. The hope is that it increases joint functionality, reduces pain and delays a total knee arthroplasty for years or even decades.”
If found successful, it will soon be available as an option to knee replacement for osteoarthritic patients across the country.
The video shows how the system works in our body
Calypso Knee System Animation: Unicompartmental Joint Unloader - YouTube
Here is a video with more information on the first patient fitted with the system
First-Ever Surgery Tests Device to Prevent Knee Replacements - YouTube
Ultrasound-guided transcervical radiofrequency ablation provides an effective, safe and minimally invasive alternative for the treatment of symptomatic uterine fibroids suggests the results of pivotal IDE trial published in the January issue of Obstetrics & Gynecology.
The Sonata System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids.
The trial enrolled 147 premenopausal women between age 25-50 years with HMB for at least three months, across 22 centers in the United States and Mexico. The size and number of fibroids varied between 1 to 5 cm diameters and 1-10 fibroids per woman respectively.
All women were followed for 12 months and results assessed in terms of relief from heavy menstrual blood loss, device-related complications, and surgical intervention rate.
Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford CT a principal investigator in the SONATA trial, said in a press release, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”
At the end of follow-up period of 12 months, 99% of patients did not require any additional surgical intervention for controlling HMB, 94% of patients reported relief from substantial blood loss with 60% reporting a 50% reduction in the amount of blood loss.
There was minimal surgical downtime with half of them returning to regular activity the next day of surgery, and 97% were satisfied with the procedure. No device-related complications were reported.
Procedure-related adverse events reported include fibroid sloughing (30.6%), cramping or pain (7.5%), leukorrhea (6.1%), and uncomplicated genitourinary infections (4.8%).
“Considering these two prospective, multicenter trials were comprised of several disparate patient populations across two continents and performed by a broad range of physician operators across various healthcare delivery systems, and clinical settings, the consistency of these results is remarkable. The reproducible results highlight the robustness of the Sonata platform design and its potential to become a new standard of care for fibroid treatment.”
Gynesonics funded the study, and lead author have received travel and lodging expenses and honoraria for speaking for Gynesonics.