Trial Adds Gemcitabine to Pleural Mesothelioma HIOC Therapy
Results of a phase I clinical trial highlight how the addition of a drug to an existing treatment option appears safe and may improve outcomes in certain patients with malignant pleural mesothelioma (MPM). The primary goal of the trial was to determine the maximum tolerated dose of gemcitabine added to cisplatin when these drugs are delivered together as heated intraoperative chemotherapy (HIOC) during surgery. Researchers have studied cisplatin alone for HIOC. The addition of gemcitabine — a chemotherapy drug often used to treat pancreatic, ovarian and breast cancers — is new. The Journal of Thoracic Oncology...
Source: Asbestos and Mesothelioma News - July 18, 2018 Category: Environmental Health Authors: Matt Mauney Source Type: news

Tackling Stigma
Sadly, stigma around health conditions remains a part of many patients ’ lives. Many will not disclose a diagnosis for fear of being judged by peers, employers, health professionals, colleagues and wider society. In fact, there is clear evidence that such negative societal attitudes impact health outcomes, resulting in diagnosis delays and impaired treatment.Some diseases are heavily stigmatized – including mental health, HIV/AIDS, hepatitis and some skin conditions – leading people to restrict their participation in society, impairing their chances of living happy, healthy lives.However, to one extent or...
Source: EyeForPharma - July 17, 2018 Category: Pharmaceuticals Authors: Lucy Fulford Source Type: news

Valsartan Recall; Wearable Salt Tracker; Killer Plastic Surgery Clots
(MedPage Today) -- Recent developments of interest in cardiovascular medicine (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 16, 2018 Category: Cardiology Source Type: news

How Common is Recurrent Kawasaki Disease?
Patient Presentation A 3.5-year-old female came to clinic with a 2-day history fever up to 101°F. The evening before she had complained of a sore throat but had no rhinorrhea, cough or rash. She was drinking reasonably well and was urinating frequently. She had been to a birthday party where an older child had had strep throat. The past medical history was positive for Kawasaki Disease diagnosed at 17 months of age and treated with intravenous immunoglobulin (IVIG) on day 6 of fever. Her echocardiograms had been negative and she was being appropriately monitored by cardiology. The family history was positive for heart...
Source: PediatricEducation.org - July 16, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Houston Chronicle, ProPublica sued by heart surgeon
A renowned heart surgeon at Baylor St. Luke's Medical Center and the Texas Heart Institute has sued the Houston Chronicle and ProPublica over recent stories. Dr. O. Howard “Bud” Frazier, co-director of cardiovascular surgery research at THI, filed the defamation lawsuit in Harris County District Court this week. The two reporters who wrote the stories were also named as defendants, and the lawsuit also lists intentional infliction of emotional dist ress as a cause of action. The lawsuit stems… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 13, 2018 Category: Pharmaceuticals Authors: Olivia Pulsinelli Source Type: news

Verapamil Success for T1D; Bariatric Surgery Wait; Self-Monitoring Without Insulin?
(MedPage Today) -- News and commentary from the endocrinology world (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 13, 2018 Category: Cardiology Source Type: news

Intuitive Grabs FDA Nod and Makes a Play to Expand Its Presence
Things continue to look up for Intuitive Surgical, a pioneer in the surgical robotics space. The Sunnyvale, CA-based company has received an FDA nod for its SureForm 60mm wristed staple and has purchased property for $1.35 million to expand its presence in the Triangle Business Center in Durham, NC, according to a report from the Triangle Business Journal. Prior to the most recent land purchase, the company had a presence in Durham, at the North Carolina State University’s Centennial Campus. TransEnterix, another mover and shaker in the surgical robotics market, is nearby. In addition to the move the company is also ...
Source: MDDI - July 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Intuitive Surgical wins FDA nod for 60mm stapler
Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared its fully-wristed 60 mm stapler, SureForm 60. The device is a single-patient-use stapler featuring 120 degrees of fully-wristed articulation, which Intuitive touts as “an industry first.” Beyond the 60 mm device, Intuitive’s stapling portfolio includes 30 and 45 mm stapler instruments. The stapler uses Intuitive’s SmartFire software to measure tissue compression before and during staple firing, automatically adjusting to the firing process as staples are formed, the company explained. Surgeons control Intuitive’s latest staple...
Source: Mass Device - July 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Surgical Wall Street Beat Intuitive Surgical Source Type: news

One Doctor & #039;s Hope for Better Patient Monitoring
Anyone who has ever been a hospital patient on a general care floor should be familiar with the standard vital check routine in which a nurse enters the room every four- to six-hours to chart your blood pressure and other vital signs to monitor your condition. But what if your condition suddenly deteriorates in between those routine checks? Is there a better way to monitor these patients? Ashish Khanna, MD, an anesthesiologist and researcher at the Cleveland Clinic believes there is. "The problem with that approach is that we are essentially seeing our patients at a snapshot of time and ignoring large chunks...
Source: MDDI - June 29, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Tubing Source Type: news

VR, AR may revamp cardiovascular imaging
Advances in virtual reality (VR) and augmented reality (AR) have prompted new...Read more on AuntMinnie.comRelated Reading: Augmented reality guides orthopedic surgery SIR: Holography platform boosts reader confidence for aneurysms Surgeons at Texas hospital use AR in sinus surgery Augmented reality may help guide facet joint injections Radiologists can future-proof themselves by embracing 3D visualization (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - June 28, 2018 Category: Radiology Source Type: news

Ellipsys & #039; FDA Nod Is a Major Turning Point for Hemodialysis
A new catheter-based technology could provide a non-surgical option for arteriovenous (AV) fistula creation. FDA recently gave de novo clearance to Avenu Medical’s Ellipsys Vascular Access System. The San Juan Capistrano, CA-based company’s device challenges the surgical option to create an AV fistula, which has been the gold standard for about 50 years. “This is what we call a disruptive technology for sure,” Ed Chang, Co-Founder, Director and VP Marketing for Avenu, told MD+DI. “We liken this to lap chole. Prior to lap chole it was always done surgically. That was the gold standard until lap...
Source: MDDI - June 27, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Do Leadless Pacemakers Really Have Fewer Complications in Patients?
A Cleveland Clinic-led study shows that leadless pacemakers have fewer mid-term and short-term complications than traditional transvenous pacemakers. The study was recently published in Heart Rhythm. “The issue with traditional pacemakers, which have been around in mainstream use since the 1960s, is that the greatest source of complications come from the incisional access that we need to create a pocket for the pacemaker,” Daniel Cantillon, M.D., research director for Cardiac Electrophysiology and Pacing at Cleveland Clinic and lead author of the study, told MD+DI. “If you look at the experience with trad...
Source: MDDI - June 26, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

7 medtech stories we missed this week: June 22, 2018
[Image from unsplash.com]From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India for its Radixact X9 System. The approval allows the company to sell the TomoTherapy platform while allowing hospitals throughout India to import the system. The Radixact and TomoTherapy Systems are radiation th...
Source: Mass Device - June 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Diagnostics Endoscopic / Arthroscopic Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Regulatory/Compliance Ultrasound Accuray Inc. Arcuro Medical BTG Masimo MedTech NuSight P Source Type: news

Inhaled nitric oxide may reduce kidney complications from heart surgery
(American Thoracic Society) Administration of nitric oxide gas during and for 24 hours following heart surgery decreased the risk of patients developing acute and chronic kidney problems, a randomized, controlled trial conducted in China found. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 22, 2018 Category: International Medicine & Public Health Source Type: news

No new trial for Bard in $4m vena cava filter loss
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard this week failed to win a new trial after a jury awarded nearly $4 million to the plaintiff in a bellwether product liability lawsuit brought over Bard’s inferior vena cava filter. Plaintiff Sherr-Una Booker was implanted in June 2007 with a Bard G2 IVC filter to mitigate her risk of pulmonary embolism during or after a surgery, according to court documents. By 2014 the G2 filter had tilted to penetrate the IVC’s wall and fractured, leaving one strut in Booker’s right atrium. During surgery in July 2014 to remove the filter and stru...
Source: Mass Device - June 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Legal News bectondickinson crbard Source Type: news

Tremelimumab and Imfinzi Combo Effective for Mesothelioma
The novel immunotherapy drug mixture of tremelimumab and Imfinzi (durvalumab) produced encouraging results in the first phase II mesothelioma clinical trial examining this combination. The study, which included 40 mesothelioma patients in Italy, was published in the June 2018 edition of The Lancet Respiratory Medicine. Similar — or even more promising — results with this combination are expected to follow soon in the United States. “Results from this study are very promising,” investigator Dr. Luana Calabro, Siena University Hospital, told Asbestos.com. “This regimen also has shown a good safe...
Source: Asbestos and Mesothelioma News - June 20, 2018 Category: Environmental Health Authors: Matt Mauney Source Type: news

Cardiovascular Comorbidity Tied to Hearing Loss in Older Old
WEDNESDAY, June 20, 2018 -- Cardiovascular disease (CVD) and related risk factors are associated with hearing loss among the older old, according to a study published online June 14 in JAMA Otolaryngology-Head& Neck Surgery. Kapil Wattamwar,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 20, 2018 Category: Pharmaceuticals Source Type: news

For Mitral Valve Surgery, Mini-Thoracotomy May Trump Robotic Approach
(MedPage Today) -- But " excellent outcomes " across the board, observational data shows (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 19, 2018 Category: Cardiology Source Type: news

Testosterone Lawsuits; Stabilizing T1D; Bariatric Surgery Pill?
(MedPage Today) -- News and commentary from the endocrinology world (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - June 15, 2018 Category: Cardiology Source Type: news

LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said. “Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. The new larger sizes allow us to treat more ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance LivaNova Source Type: news

CleanCision Wins Readers ’ Choice Award in MDEA Competition
There was much pomp and circumstance at the Medical Design Excellence Awards Tuesday as the best technologies were honored at the Jacob K. Javits Convention Center in New York. For one technology, however, it was a strong call of validation. CleanCision, earned the overall Reader’s Choice Award, which spans all categories in the competition. The active cleansing technology also earned the 2018 Medical Device Excellence Award Bronze Medal in the ER and OR Tools Category. CleanCision was developed by San Carlos, CA-based Prescient Medical. “We’re thrilled and we’re honored for validation of what we&rs...
Source: MDDI - June 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Design Source Type: news

Can You Smell a Bidding War Brewing Over Boston Scientific?
Monday's headlines that Stryker may be making a play for Boston Scientific prompted industry analysts to play the "what if" game, dissecting potential benefits of such a marriage, how a deal of that size might impact the broader medical device industry, and the potential of other bidders to emerge. Just to be clear though, we still do not know at this point if Stryker really has approached Boston Scientific about a potential takeover, or if Boston Scientific is even receptive to the idea. Both companies declined to comment on the speculation Monday, citing their respective company policies. Canaccord Genuity's Ja...
Source: MDDI - June 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Nintedanib ‘ Superior ’ to Bevacizumab for Mesothelioma Treatment
Researchers in Austria, Germany and Hungary have added to the growing belief that the anti-cancer drug nintedanib may soon become a significant part of standard-of-care treatment for malignant pleural mesothelioma. In their study published recently in Clinical Cancer Research, nintedanib demonstrated an ability to inhibit the growth and the migration of mesothelioma tumor cells effectively in animal models. “This is a step in the right direction, another part of the evolutionary process of treatment advancements with this difficult disease,” Dr. Balazs Hegedus, department of thoracic surgery, University of Dui...
Source: Asbestos and Mesothelioma News - June 11, 2018 Category: Environmental Health Authors: Matt Mauney Source Type: news

#MayoClinicRadio podcast: 6/9/18
Listen: Mayo Clinic Radio podcast 6/9/18 On the Mayo Clinic Radio podcast, Dr. Alexander Shin, an orthopedic surgeon at Mayo Clinic,?discusses diagnosis and treatment of brachial plexus injuries. Dr. Shin also covers carpal tunnel syndrome.?Also on the podcast, Dr. Naima Covassin, a cardiovascular disease researcher at Mayo Clinic, shares the findings of a recent Mayo [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - June 11, 2018 Category: Databases & Libraries Source Type: news

FDA labels IABP recall for Getinge ’ s Maquet, Datascope as Class I
The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The Cardiosave hybrid intra-aortic balloon pump is designed for use as a cardiac assist device for use with patients undergoing cardiac and non-cardiac surgery, as well as to treat patients with acute coronary syndrome or complications from heart failure, the FDA wrote in its ...
Source: Mass Device - June 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Recalls Datascope Corp. Getinge Maquet Cardiovascular LLC Source Type: news

‘Right to Try Act’ Could Aid Mesothelioma Patients
Patients with mesothelioma may soon find an easier path to experimental drugs and treatments after President Donald Trump signed the “Right to Try Act” into law last week. The new legislation will give terminally ill patients a more direct and quicker line to drugs still awaiting approval from the U.S. Food and Drug Administration (FDA), bypassing the often-cumbersome application process. The law also will protect doctors and pharmaceutical companies from the legal risks of allowing unapproved treatments. The bill was passed by the Senate in August 2017 and cleared the House of Representatives late last month....
Source: Asbestos and Mesothelioma News - June 6, 2018 Category: Environmental Health Authors: Matt Mauney Source Type: news

Urinary Biomarkers Predict AKI After Cardiovascular Surgery Urinary Biomarkers Predict AKI After Cardiovascular Surgery
Urinary biomarkers, in combination with clinical risk scores, may help predict the progression of acute kidney injury after cardiovascular surgery.Critical Care (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 6, 2018 Category: Consumer Health News Tags: Critical Care Journal Article Source Type: news

JC Medical Becoming Serious Challenger in TAVR Fray
Edwards Lifesciences and Medtronic have been at the forefront of the transcatheter aortic valve replacement (TAVR) market for a few years now. However, as time goes on, the two companies are facing increasing competition from a  number of challengers. These companies aren’t necessarily new – but they have passed the test of time to put them on the field of being relevant in the market. The latest company to show margins of success is privately held firm, JC Medical, which was formed in 2009. On Thursday, the Burlingame, CA-based company said it had treated the first patient with the J-Valve TF System ...
Source: MDDI - May 31, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

It Turns Out Stapler Choice Matters in Lung Cancer Surgery
Video-assisted lobectomies performed with powered staplers resulted in nearly half as many patient bleeding complications as those conducted with manual staplers, according to a recent study. Patients treated with powered staplers were released from the hospital one day earlier than those whose surgeons used manual staplers. The retrospective study, funded by powered-stapler maker Ethicon, also indicated shortened hospital stays and 10% lower costs among the patients treated with the powered devices, most of which were manufactured by Ethicon, part of Johnson & Johnson. Most of the manual devices were made by Medtronic...
Source: MDDI - May 30, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: R & D Source Type: news

Report: Prominent heart doc pushed ethical envelope in pursuit of innovation
Prominent cardiac surgeon and heart device developer Dr. O.H. Frazier regularly cut corners and skirted ethical guidelines in his pursuit of cardiovascular innovations, according to a combined Houston Chronicle and ProPublica report. Accusations against Dr. Frazier include the implantation of experimental heart pumps in patients who weren’t approved to be included in clinical trials, favoring experimental heart pumps in procedures over proven treatments and not acknowledging issues with the devices, failures to disclose consulting fees and research grants and allowing unlicensed researchers to treat patients in his p...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Research & Development Source Type: news

Awake Video-Assisted Surgery Option for'Inoperable' Lungs Awake Video-Assisted Surgery Option for'Inoperable' Lungs
For patients with poor lung function who are not good candidates for surgery because of the risks associated with general anesthesia, awake video-assisted thoracic surgery could be an alternative.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 24, 2018 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

EuroPCR 2018 Roundup: Edwards reportedly pauses Centera valve EU launch
Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting. Delivery of the unit and its use in clinical cases are slated to resume during the third quarter, according to the letter, with Edwards claiming there will be no impact on its financial guidance for the year. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized deli...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Edwards Lifesciences Source Type: news

LAA Closure Tied to Better Heart Surgery Outcomes
(MedPage Today) -- Lower stroke and mortality risks observed (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 23, 2018 Category: Cardiology Source Type: news

Carvedilol Helps Protect Heart During PPGL Surgery
(MedPage Today) -- Med offers superior blocking for cardiac complications in pheochromocytoma (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 23, 2018 Category: Cardiology Source Type: news

Real World Data Could Give Edwards Edge in TAVR
Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR. The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. Nearly 2,000 patients were involved and treated in more than 450 commercial centers around the U....
Source: MDDI - May 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follo...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news

Robert Jarvik: An Innovator with Heart
Robert Jarvik, MD, remembers Dec. 2, 1982, as vividly as if it were last week. He was 36 at the time and a device he designed, the Jarvik 7 artificial heart, was about to be implanted into a human patient for the first time. That patient, a retired dentist named Barney Clark, had been at the University of Utah Hospital in Salt Lake City for about a week, and his medical team, lead by William DeVries, MD, planned to put off the surgery just a little while longer in hopes of getting Clark as strong as possible for the operation. But Clark wasn't getting stronger. Robert Jarvik, MD, will receive the MDEA Lifetime Ac...
Source: MDDI - May 17, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M East (New York) Cardiovascular Design Source Type: news

Acetaminophen Cuts Kidney Risk in Kids' Heart Surgery
(MedPage Today) -- The higher the dose, the lower the odds of acute kidney injury (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 15, 2018 Category: Cardiology Source Type: news

Less Acute Kidney Injury in Kids' Heart Surgery With Acetaminophen
(MedPage Today) -- The higher the dose, the lower the observed odds of acute kidney injury (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 15, 2018 Category: Cardiology Source Type: news

Chemo, radiation, therapy — and don't forget exercise
The prescription pad is increasingly getting a workout as exercise is being prescribed for a host of conditions, from depression to diabetes to cardiovascular disease. Now a group of Australian oncologists want to prescribe exercise for all cancer patients, alongside surgery, chemotherapy and radiation. (Source: CBC | Health)
Source: CBC | Health - May 15, 2018 Category: Consumer Health News Tags: News/Health Source Type: news

7 medtech stories we missed this week: May 11, 2018
[Image from unsplash.com]From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of the Therapeutic Products Directorate in Canada to amend its existing Canadian medical device license to include distribution of the ReShape Balloon and its accessories. The ReShape Balloon is FDA approved and is a non-s...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Hospital Care Imaging mHealth (Mobile Health) Neurological Patient Monitoring Regulatory/Compliance Brainsway Conavi Exact Imaging innovativehealth MedTech PeraHealth qtm Source Type: news

Simple walking test helps predict risk for cognitive issues after heart surgery
(Elsevier) The distance a patient can walk in 6-minutes before a heart operation may be a clue to whether that patient will develop problems with memory, concentration, and attention after the procedure, according to a study published online today in The Annals of Thoracic Surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 10, 2018 Category: International Medicine & Public Health Source Type: news

All heart: A Google executive ’ s real-world experience with medtech
Heidi Dohse, senior program manager at Google After hearing the story of her 10 cardiac surgeries and seven pacemakers, you could be forgiven for thinking that Heidi Dohse has a weak heart. But the Google executive, endurance cyclist and, now, inspirational speaker she may have a stronger heart than most people on the planet. Dohse, a senior program manager at Google and upcoming keynote speaker at DeviceTalks Minnesota, was 18 when an EKG before a routine knee surgery to clean out scar tissue, which had built up during her days as a competitive skier and professional windsurfer, uncovered a rare and potentially deadly arr...
Source: Mass Device - May 7, 2018 Category: Medical Devices Authors: Brian Johnson Tags: Business/Financial News Cardiovascular DeviceTalks Q&A devicetalksminnesota google Google Inc. Source Type: news

Integer divests AS & amp;O Business to MedPlast for $600M
Integer Holdings Corp. is stepping way from one of its core businesses to invest more in its Cardio & Vascular and Cardiac & Neuromodulation offerings. The Frisco, TX-based company said it is divesting its Advanced Surgical and Orthopedics (AS&O) unit to MedPlast for $600 million. The acquisition is set to close in the third quarter of this year. Integer’s AS&O capabilities will bolster MedPlast’s portfolio of manufacturing solutions. In addition to expanding MedPlast’s offering into a broad range of metals manufacturing capabilities, including machining, stamping, coating, and metal formi...
Source: MDDI - May 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

J & J ’ s Acclarent launches TruDi ENT nav system
Johnson & Johnson‘s (NYSE:JNJ) Acclarent said late last month it launched the TruDi real-time, three-dimensional navigation system designed for ENT procedures. Acclarent said that the first commercial procedures were performed with the device on April 16, after having previously won FDA 510(k) clearance. The TruDi system is an electromagnetic image-guided navigation system designed for endoscopic sinus surgery procedures, and is intended for use during intranasal and paranasal image-guided navigation procedures for eligible patients who require sinus surgery. The newly launched system enables the use of the ...
Source: Mass Device - May 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Otolaryngology Ear, Nose & Throat Acclarent Inc. johnsonandjohnson Source Type: news

Is LivaNova & #039;s Refined Focus Strategy Really Working?
LivaNova has beaten consensus on sales and earnings per share (eps) in the first quarter of 2018. The earnings  seem to suggest the London-based company’s newly adopted strategy to focus on both its cardiac surgery and neuromodulation businesses is working. However, despite  the strong earnings, shares of the company dipped as much as 8% on Wednesday. LivaNova raised $250.4 million in 1Q18 easily topping analysts' estimates of $243.42 million. It should also be noted that LivaNova's 1Q18 earnings were a 10.4% increase over the amount earned in the first quarter of 2017. EPS for the quarter was 68 ...
Source: MDDI - May 2, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

Is InVivo & #039;s Neuro-Spinal Scaffold Back on Track After Halted Trial?
InVivo Therapeutics appears to be back on track with its Neuro-Spinal Scaffold, after pausing enrollment in its INSPIRE study last year due to three patients who had received the implant died.  The Cambridge, MA-based company presented six-month primary endpoint results from the single-arm study this week at the American Association of Neurological Surgeons meeting. FDA also gave InVivo the green light recently for a randomized, controlled study of the device that will include 20 patients. In July, InVivo halted enrollment in the INSPIRE study following the third patient death. Although the deaths were not b...
Source: MDDI - May 2, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Implants Source Type: news

Opioids Often Over-Prescribed After Hiatal Hernia Surgery
WEDNESDAY, May 2, 2018 -- Patients use fewer opioids than are prescribed after hiatal hernia repair (HHR), according to a study presented at the annual meeting of the American Association for Thoracic Surgery, held from April 28 to May 1 in San... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 2, 2018 Category: Pharmaceuticals Source Type: news

For patients with esophageal cancer, status of lymph nodes after preoperative therapy determines survival
(American Association for Thoracic Surgery) The status of lymph nodes rather than the status of the primary tumor following preoperative neoadjuvant chemotherapy or chemoradiation therapy is the most important factor that determines whether patients with locally advanced esophageal cancer will survive. The study presented at the AATS 98th Annual Meeting indicates that while preoperative chemotherapy and radiation therapy improve survival of patients with esophageal cancer, patients with malignant lymph nodes following therapy were less likely to survive than patients with no cancer in the lymph nodes. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - May 1, 2018 Category: Cancer & Oncology Source Type: news

Terumo Aortic launches feasibility study of RelayBranch thoracic stent-graft
Terumo Aortic, which formed earlier this month from a merger between Terumo Corp. (TYO:4543) subsidiary Vascutek and Bolton Medical, said today it launched an early feasibility study of its RelayBranch thoracic stent-graft system. The Sunrise, Fla.-based company said that the first two patients in the study have been implanted with the device by Dr. Luis Sanchez and Dr. Marc Moon of St. Louis’ Washington University, with the procedures performed at Barnes Jewish Hospital. “RelayBranch expands the range of endovascular treatment options for a high risk population. We are very pleased to be able to offe...
Source: Mass Device - April 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stent Grafts Vascular terumoaortic Source Type: news