Multisystemic therapy for child abuse and neglect: do parents show improvement in parental mental health problems and parental stress? - Hefti S, P érez T, Fürstenau U, Rhiner B, Swenson CC, Schmid M.
Multisystemic Therapy for Child Abuse and Neglect (MST-CAN) is an evidence-based program for families with children who experience maltreatment. This clinical trial is the first evaluation of MST-CAN in a German-speaking area. Parental psychological proble... (Source: SafetyLit)
Source: SafetyLit - December 8, 2018 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news

The effect of group exercises on balance, mobility, and depressive symptoms in older adults with mild cognitive impairment: a randomized controlled trial - Langoni CDS, Resende TL, Barcellos AB, Cecchele B, da Rosa JN, Knob MS, Silva TDN, Diogo TS, da Silva IG, Schw.e CHA.
OBJECTIVE:: To determine the effects of group exercises on balance, mobility, and depressive symptoms in community-dwelling older adults with mild cognitive impairment. DESIGN:: Single blinded, randomized, matched pairs clinical trial. SETTING:: Fo... (Source: SafetyLit)
Source: SafetyLit - December 8, 2018 Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news

CardioFocus Finishes up Enrollment for HeartLight X3 Trial
CardioFocus is looking to bring the next generation of its endoscopic ablation system to the market and that could happen sometime next year. The Marlborough, MA-based company and finalist in MD+DI’s Manufacturer of the Year Award in 2012, took bold steps on this front this past week by completing enrollment for a trial evaluating its HeartLight X3 System. The HeartLight X3 System uses laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause atrial fibrillation, the most common type of cardiac rhythm disorder. Roughly 60 patients were treated with the HeartLight X3 ...
Source: MDDI - December 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

SGLT2 Inhibitors: Is This the Start of a New Era? SGLT2 Inhibitors: Is This the Start of a New Era?
Gregory Nichols discusses exciting new clinical trial results demonstrating the benefits of SGLT2 inhibitors, as presented at the AHA 2018 Scientific Sessions.Medscape Diabetes & Endocrinology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 7, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology Article Source Type: news

Is Low-level Laser Therapy an effective method to alleviate pain induced by active orthodontic alignment arch-wire? A randomized clinical trial.
ConclusionsLLLT is effective in alleviating the intensity and duration of pain experienced by patients after the engagement of alignment arch-wire. However, there is no specific indication for the usage of LLLT according to the amount of crowding. (Source: Dental Technology Blog)
Source: Dental Technology Blog - December 6, 2018 Category: Dentistry Source Type: news

Corindus touts first-in-human coronary telerobotics study with CorPath system
Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India. The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab. In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said. The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Pat...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Robotics Corindus Vascular Robotics Source Type: news

Olympus wins FDA nod for Spiration bronchial valve
Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device. The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during a bronchoscopic procedure to reduce lung volume in diseased lung sections and allow healthier tissue in the remaining portion of the lung to function better. Approval of the device came based on the results from the Emprove clinical trial of the SV...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Olympus Source Type: news

Vapotherm touts automated oxygen controller in preemie study
A recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range. The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % for manual control alone, the company said in a statement. The study was published in the Archives of Disease in Childhood: Fetal and Neonatal Editio...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Hospital Care News Well Pediatrics Research & Development Wall Street Beat Vapotherm Source Type: news

RCC: Establishing Particular Agents' Roles in Sequencing
Dr. Brian Rini discusses different clinical trials for kidney cancer.12/06/2018 (Source: Kidney Cancer Association)
Source: Kidney Cancer Association - December 6, 2018 Category: Urology & Nephrology Source Type: news

Novocure touts analysis of pivotal glioblastoma trial results
Novocure (NSDQ:NVCR) today touted the results of a retrospective sub-group analysis of its EF-14 Phase III pivotal trial in patients with newly diagnosed glioblastoma. The analysis, which was published in the Journal of Neuro-Oncology, demonstrated that more time on Novocure’s Optune device predicted increased survival in people who received Optune plus temozolomide compared to those who received just temozolomide. Gte the full story at our sister site, Drug Delivery Business News. The post Novocure touts analysis of pivotal glioblastoma trial results appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Oncology Pharmaceuticals Wall Street Beat NovoCure Source Type: news

Black women have worse breast cancer outcomes despite receiving similar treatment as white women
(American Association for Cancer Research) Even with equivalent treatments in women with hormone receptor-positive, HER2-negative breast cancer, black women had significantly higher breast cancer recurrence and increased overall mortality compared to white women in a large phase III clinical trial, TAILORx, according to data presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 6, 2018 Category: International Medicine & Public Health Source Type: news

Circulating tumor cell count could help choose treatment for metastatic breast cancer patients
(American Association for Cancer Research) Circulating tumor-cell (CTC) count could be used to choose hormone therapy or chemotherapy as frontline treatment for patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer, according to data from the phase III STIC CTC clinical trial presented at the 2018 San Antonio Breast Cancer Symposium. In the case of discrepancy between CTC count-based treatment choice and physician's choice of treatment, frontline chemotherapy was associated with a significant gain in overall survival. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 6, 2018 Category: Cancer & Oncology Source Type: news

Low-dose tamoxifen reduced recurrence and new disease for patients with DCIS, LCIS, and ADH
(American Association for Cancer Research) Treatment with a low dose of tamoxifen (5 mg per day) halved the risk of disease recurrence and new disease for women who had been treated with surgery following a diagnosis of breast intraepithelial neoplasia compared with placebo, and it did not cause more serious adverse events, according to data from the randomized, phase III TAM-01 clinical trial presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 6, 2018 Category: Cancer & Oncology Source Type: news

Liquid biopsies in SOLAR-1 trial predict benefit of Alpelisib in PIK3CA-mutant breast cancer
(American Association for Cancer Research) Liquid biopsy-based assessment of PIK3CA mutational status served as a better indicator of progression-free survival compared with analysis of tissue biopsy in breast cancer patients enrolled in the phase III clinical trial SOLAR-1, according to data presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 6, 2018 Category: Cancer & Oncology Source Type: news

Axillary RT and lymph node surgery yielded comparable outcomes for patients with breast cancer
(American Association for Cancer Research) Patients with early-stage breast cancer who had cancer detected in a sentinel lymph node biopsy had comparable 10-year recurrence and survival rates following either axillary radiotherapy or axillary lymph node dissection, according to data from the randomized, phase III AMAROS clinical trial presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 6, 2018 Category: Cancer & Oncology Source Type: news

Past Covidien, ev3 Activities are Costing Medtronic a Hefty Sum
Sometimes acquiring other companies means taking the bad with the good. In Medtronic's case, that means settling multiple Department of Justice claims against ev3, a business Medtronic owns by way of its Covidien acquisition. Covidien bought ev3 in 2010 and Medtronic finalized its $49.9 billion Covidien deal in early 2015. Now, Medtronic is paying the price for activities that ev3 allegedly conducted between 2005 and 2009 involving the Onyx Liquid Embolic System. FDA approved the device in 2005 as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations ...
Source: MDDI - December 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Baboon survives for six months after receiving pig heart transplant
Clinical trials of pig organs in humans could begin in as little as three years, say researchersThe transplantation of pig organs into humans is a step closer to becoming a reality after researchers showed the organs can function long-term in baboons.The transplanting of organs from one species to another, known as xenotransplantation, has been the subject of research for many years. Proponents say it could help get around a shortage of human organs.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - December 5, 2018 Category: Science Authors: Nicola Davis Tags: Medical research Organ donation Health Society Science Germany World news Europe Source Type: news

Edwards prioritizes TAVR, TMTT tech in investor day presentation
Edwards Lifesciences (NYSE:EW) today released its strategies for longer-term growth, updated on its technology pipeline and released preliminary financial guidance for the coming fiscal year in its investor day presentation. Edwards lead with news about its transcatheter aortic valve replacement technologies, saying it expects that TAVR opportunity will reach approximately $7 billion by 2024, and that it estimates its TAVR sales next year will be between $2.4 billion and $2.7 billion. The Irvine, Calif.-based company said that it plans to continue investing in TAVR research & development and clinical trials and th...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat Edwards Lifesciences Source Type: news

Gas-Filled Balloon Device Is Safe, Effective for Weight Loss Gas-Filled Balloon Device Is Safe, Effective for Weight Loss
In real-world data, the Obalon 3-balloon system appeared safe and even more effective at weight loss than it had been in the company's clinical trials.Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 5, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Adjuvant chemo might not add benefit in breast cancer patients who have excellent response to neoadjuvant chemo
(American Association for Cancer Research) Pathological complete response (pCR) after neoadjuvant (presurgery) chemotherapy was associated with significantly lower recurrence risk and higher overall survival in breast cancer patients, and pCR after neoadjuvant chemotherapy had similar association with improved outcomes among those who received additional chemotherapy following surgery (adjuvant chemotherapy) versus those who did not, according to meta-analyses of data from 52 clinical trials, presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 5, 2018 Category: Cancer & Oncology Source Type: news

Phase III KATHERINE trial crossed early reporting boundary and met its primary endpoint
(American Association for Cancer Research) Substituting trastuzumab emtansine (T-DM1, Kadcyla) for adjuvant trastuzumab (Herceptin) in patients who had residual disease after receiving neoadjuvant chemotherapy and trastuzumab reduced the risk of developing an invasive recurrence of HER2-positive early-stage breast cancer by 50 percent, according to data from the phase III clinical trial KATHERINE presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 5, 2018 Category: Cancer & Oncology Source Type: news

Adjuvant capecitabine did not improve outcomes for patients with early triple-negative breast cancer
(American Association for Cancer Research) Treating patients who had early-stage triple-negative breast cancer with the chemotherapy agent capecitabine after they completed surgery and standard chemotherapy did not significantly improve disease-free or overall survival compared with observation, according to data from the randomized, phase III GEICAM/CIBOMA clinical trial presented at the 2018 San Antonio Breast Cancer Symposium. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 5, 2018 Category: Cancer & Oncology Source Type: news

UAB Comprehensive Cancer Center gets $30M gift from O'Neal Industries
O'Neal Industries and its shareholders have given the UAB Comprehensive Cancer Center the largest gift in UAB history. The $30 million gift will allow the cancer center to recruit additional cancer scientists and clinicians, expand cancer treatment clinical trials at UAB, plant the seed for a UAB/biotech collaboration that could eventually grow into a Birmingham biotechnology park and create a distinctive brand ar ound the cancer center. Moving forward, the center will be known as the O’Neal… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 4, 2018 Category: Biotechnology Authors: Ty West Source Type: news

UAB Comprehensive Cancer Center gets $30M gift from O'Neal Industries
O'Neal Industries and its shareholders have given the UAB Comprehensive Cancer Center the largest gift in UAB history. The $30 million gift will allow the cancer center to recruit additional cancer scientists and clinicians, expand cancer treatment clinical trials at UAB, plant the seed for a UAB/biotech collaboration that could eventually grow into a Birmingham biotechnology park and create a distinctive brand ar ound the cancer center. Moving forward, the center will be known as the O’Neal… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 4, 2018 Category: Pharmaceuticals Authors: Ty West Source Type: news

FDA clears Editas to test gene-editing drug in humans
The FDA has signed off on Cambridge startup Editas Medicine's plans to launch its first-ever clinical trial, which will make it among the first U.S. companies to test the gene editing technology CRISPR/Cas9 in humans. Editas (Nasdaq: EDIT) said that the FDA approved the launch of an early-stage trial of its drug for the most common cause of childhood blindness. The treatment uses CRISPR/Cas9, which allows scientists to replace or eliminate disease-causing segments of DNA. The study, which Editas… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 4, 2018 Category: Biotechnology Authors: Allison DeAngelis Source Type: news

FDA clears Editas to test gene-editing drug in humans
The FDA has signed off on Cambridge startup Editas Medicine's plans to launch its first-ever clinical trial, which will make it among the first U.S. companies to test the gene editing technology CRISPR/Cas9 in humans. Editas (Nasdaq: EDIT) said that the FDA approved the launch of an early-stage trial of its drug for the most common cause of childhood blindness. The treatment uses CRISPR/Cas9, which allows scientists to replace or eliminate disease-causing segments of DNA. The study, which Editas… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 4, 2018 Category: Pharmaceuticals Authors: Allison DeAngelis Source Type: news

Gene therapy treatment reverses sickle cell anemia, early trial results show
A new gene therapy for sickle cell anemia has shown promise in early clinical trials after reversing the condition's symptoms in two adults, researchers report. (Source: Health News - UPI.com)
Source: Health News - UPI.com - December 4, 2018 Category: Consumer Health News Source Type: news

$5.1B deal: GSK buying ovarian cancer drug developer
In a major move to boost its oncology product pipeline, GlaxoSmithKline entered into a definitive agreement Monday to acquire Boston-area biopharmaceutical company Tesaro for $5.1 billion. Tesaro (NASDAQ: TSRO) of Waltham, Mass., markets the ovarian cancer therapy Zejula, which is approved in the United States and Europe. The company is also conducting clinical trials that if successful could lead to an expanded use of the drug, as a monotherapy and in combination with other ovaria n cancer treatments. “The… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 4, 2018 Category: Biotechnology Authors: John George Source Type: news

Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device. The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. The process is used in roughly 80 million office-based eye exams each year in the U.S., according to Eyenovia. Get the full story at our sister site, Drug Delivery Business News. The post Eyenovia kicks off second Ph3 trial for pupil dilation tech appeared fi...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Optical/Ophthalmic Pharmaceuticals Wall Street Beat Eyenovia Inc. Source Type: news

Pivotal trial kicks off for Edwards Lifesciences ’ Pascal mitral repair device
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said. The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said. “As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Source Type: news

Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold
In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. The results were first presented earlier this year at the 2018 Transcatheter Cardiovascular Therapeutics meeting. Get the full story at our sister site, Drug Delivery Business News. The post ...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Biosensors International Group Ltd. Biotronik Source Type: news

Axonics bids for FDA approval of sacral neuromod device
Fresh from a $138 million initial public offering, Axonics Modulation Technologies (NSDQ:AXNX) said today that it re-filed yesterday for pre-market approval from the FDA for its r-SNM sacral neuromodulation treatment for urinary and bowel dysfunction. The Irvine, Calif.-based company said it last month withdrew the PMA application it filed in January 2018 after an FDA review prompted the agency to request additional information. The re-filing includes all of the prior bid plus responses to the federal safety watchdog’s queries, Axonics said. The approval bid is a “literature-based PMA” that doesn&rsq...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Axonics Modulation Technologies Source Type: news

Novartis goes after Roche asthma medicine Xolair with new drug
Novartis said it is pushing ahead with a late-stage study of its experimental drug ligelizumab after announcing the medicine outperformed Roche's Xolair in a Phase II clinical trial against urticaria, also known as hives. (Source: Reuters: Health)
Source: Reuters: Health - December 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Red tape preventing cancer patients from accessing new drugs
Some cancers have had no new drugs licensed since 2000, according to Institute of Cancer Research reportCancer patients are missing out on innovative new drugs, with red tape covering clinical trials and licensing among the factors to blame, according to a report by theUK ’s Institute of Cancer Research.Children ’s cancers have received little in the way of new treatments, a finding the authors put down to drug companies failing to invest in these rare conditions and using regulatory loopholes to avoid conducting the necessary clinical trials.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - December 4, 2018 Category: Science Authors: Nicola Davis Tags: Cancer research Medical research Science Health Drugs Society NHS Health policy UK news Source Type: news

Drug dramatically reduces risk of dangerous blood clots in cancer patients
(The Ottawa Hospital) A large clinical trial published in the New England Journal of Medicine provides the first approach for safely preventing blood clots (venous thromboembolism) in people with cancer. Venous thromboembolism is the second leading cause of death in cancer patients and it can also affect quality of life. About half of people newly diagnosed with a solid cancer could be candidates for the strategy, which involves a low dose of a direct oral anticoagulant called apixaban. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - December 4, 2018 Category: Cancer & Oncology Source Type: news

Diabeloop Is 2nd to Win CE Mark for Artificial Pancreas System
Medtronic has a new contender for its MiniMed 670g insulin pump, dubbed the artificial pancreas. The Dublin-based company could see a healthy competitor in Diabeloop, a small firm that recently won CE-mark for DBLG1, a hybrid closed-loop diabetes management system. DLBG1, is a patch work system that uses technologies from different companies to provide glucose measurements every five minutes. The system connects DexCom’s G6 Continuous Glucose Monitor, Kaleido’s patch insulin pump and an algorithm to a user’s phone. DLBG1 has had pretty good data -so far. In June, the co...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Statins are being overprescribed, study suggests
The risks of statins for primary prevention are greater than the benefits for many patients Related items fromOnMedica Withdrawn valsartan meds not linked to short-term cancer risk Direct oral anticoagulants as safe as warfarin after VTE Too few women take part in many CVD clinical trials Use of DPP-4 inhibitors associated with increased risk of IBD Metformin doesn ’t help HbA1c in teens with type 1 diabetes (Source: OnMedica Latest News)
Source: OnMedica Latest News - December 4, 2018 Category: UK Health Source Type: news

BTG ’ s bioconvertible IVC filter implanted in Arizona patients
BTG (LSE: BTG) today announced the first successful implantation of its Sentry bioconvertible inferior vena cava (IVC) filter in patients outside of a clinical trial. The Sentry device won FDA 510(k) clearance in 2017. London-based BTG acquired the device in September through its purchase of Galway, Ireland–based Novate. Get the full story on our sister site Medical Design & Outsourcing. The post BTG’s bioconvertible IVC filter implanted in Arizona patients appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Implants Cardiovascular News Well BTG Source Type: news

FDA clears testing for another gene-editing drug in humans
The FDA has signed off on a Massachusetts startup's plans to launch its first-ever clinical trial, which will make it among the first U.S. companies to test the gene editing technology CRISPR/Cas9 in humans. Cambridge-based Editas Medicine (Nasdaq: EDIT) said Friday, Nov. 30, that the FDA had approved the launch of an early-stage trial of its drug for the most common cause of childhood blindness. The treatment uses CRISPR/Cas9, which allows scientists to replace or eliminate disease-causing segments… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 3, 2018 Category: Biotechnology Authors: Allison DeAngelis Source Type: news

FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing. The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation, the Irvine, Calif.-based company said. JenaValve said the IDE studies are part of its larger CE Mark program in Europe and New Zealand. “We are extremely pleased with the initial clinica...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves JenaValve Source Type: news

Micro Interventional Devices touts early results in tricuspid repair trial
Micro Interventional Devices last week touted early results from a study of its minimally invasive annuloplasty technology as a treatment for severe tricuspid regurgitation. The technology has been successfully implanted percutaneously in four patients, the company reported. Get the full story at our sister site, Medical Design & Outsourcing. The post Micro Interventional Devices touts early results in tricuspid repair trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Micro Interventional Devices Source Type: news

Medtronic studies use of both heat and cold for cardiac ablation
Medtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment. The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic. During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used bot...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Cardiovascular Clinical Trials Featured News Well Research & Development Surgical Medtronic Source Type: news

Alfred Mann Foundation chairman looks outward to extend founder ’ s legacy
When medtech pioneer Alfred Mann died in February 2016, he left behind a rich legacy of pure innovation and patient impact spanning the breadth of healthcare, from cardiology to hearing impairment, blindness and diabetes that will improve the lives of patients for decades to come. Extending and advancing that legacy is now the mission of Dr. Robert Greenberg, who took over as the foundation’s chairman in July. Speaking ahead of his appearance next week at MassDevice.com’s DeviceTalks West event in Costa Mesa, Greenberg told us that he’s looking to expand the foundation’s reach into the early-st...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Alfred Mann Foundation DeviceTalks West Source Type: news

Data Sharing in Action: When Drug Companies Open Their Trial Vaults
YODA, a program facilitated by Yale University researchers, has successfully distributed clinical trial records from Johnson& Johnson and Medtronic to external researchers since 2013. (Source: The Scientist)
Source: The Scientist - December 3, 2018 Category: Science Tags: News & Opinion Source Type: news

Effect on fear of falling and functionality of three intervention programs. A randomised clinical trial - Due ñas EP, Ramírez LP, Ponce E, Curcio CL.
INTRODUCTION: The fear of falling has a high prevalence in the community, and intervention programs for this condition are scarce, making it is necessary to strengthen this type of therapy in order to prevent adverse consequences in the elderly population.... (Source: SafetyLit)
Source: SafetyLit - December 3, 2018 Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news

Preliminary efficacy of online traumatic brain injury professional development for educators: an exploratory randomized clinical trial - Glang AE, McCart M, Slocumb J, Gau JM, Davies SC, Gomez D, Beck L.
OBJECTIVE: To examine the efficacy of an online traumatic brain injury (TBI) professional development intervention, In the Classroom After Concussion: Best Practices for Student Success. DESIGN: A randomized controlled trial with a sample of 100 ge... (Source: SafetyLit)
Source: SafetyLit - December 3, 2018 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news

Otago researchers discover a promising therapy for improving heart attack survivorship
(University of Otago) In pre-clinical trials, University of Otago researchers have discovered a promising new therapy that has the potential to be used clinically for improving survival rates for people who suffer a heart attack. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - December 3, 2018 Category: Biology Source Type: news

Early clinical trial data show gene therapy reversing sickle cell anemia
(Cincinnati Children's Hospital Medical Center) After over a decade of preclinical research and development, a new gene therapy treatment for Sickle Cell Anemia (SCA) is reversing disease symptoms in two adults and showing early potential for transportability to resource-challenged parts of the world where SCA is most common. Preliminary data from a pilot Phase 1-2 clinical trial testing the gene-addition therapy were presented Dec. 3 at the American Society of Hematology's (ASH) annual meeting in San Diego. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 3, 2018 Category: International Medicine & Public Health Source Type: news

Targeting sepsis, the leading cause of ICU deaths, with a nanocarrier-delivered microRNA
(Medical University of South Carolina) One obstacle to therapeutic use of microRNAs (miRNA), which are in clinical trial for a number of diseases, are ribonucleases, whose job it is to destroy them. Medical University of South Carolina researchers report in Inflammation that an miRNA (miR-126) protective against sepsis can be delivered effectively via a nanocarrier. Almost 67 percent of mice treated with one of the nanocarrier/miR-126 complexes were still alive at seven days vs. just 25 percent of controls. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 3, 2018 Category: International Medicine & Public Health Source Type: news

CAR T Cells:'Validation That They Keep Living and Keep Working'CAR T Cells:'Validation That They Keep Living and Keep Working '
New longer-term data on CAR T cells from pivotal clinical trials show durable responses, with some patients remaining in remission for years after one infusion.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 2, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news