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GVI partners with cardiologist to train African surgeons
A team of surgeons from Great Lakes Cardiovascular have completed their first live proctorship on pacemakers for 30 surgeons across Africa. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - November 20, 2017 Category: American Health Authors: Tracey Drury Source Type: news

GVI partners with cardiologist to train African surgeons
A team of surgeons from Great Lakes Cardiovascular have completed their first live proctorship on pacemakers for 30 surgeons across Africa. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - November 20, 2017 Category: Biotechnology Authors: Tracey Drury Source Type: news

French Oncologists Upgrade Mesothelioma Standard of Care
Oncologists throughout France have joined the U.S.-based National Comprehensive Cancer Network (NCCN) in upgrading their recommended standard-of-care treatment regimen for unresectable pleural mesothelioma. Both groups have added bevacizumab (Avastin) to the traditional cisplatin and pemetrexed chemotherapy combination, expecting to see longer patient survival. “This is a major advancement for the care of mesothelioma patients,” Dr. Gerard Zalcman, head of thoracic oncology at Bichat-Claude Bernard Hospital, told Asbestos.com. “Clearly, this drug can change the natural history of this tumor.” Bevaci...
Source: Asbestos and Mesothelioma News - November 20, 2017 Category: Environmental Health Authors: Daniel King Tags: American Society of Clinical Oncology Avastin bevacizumab Bichat-Claude Bernard Hospital French Cooperative Thoracic Intergroup Gerard Zalcman National Comprehensive Cancer Network nintedanib Ofev pleural mesothelioma chemotherapy Source Type: news

Developing a New Score: How Machine Learning Improves Risk Prediction
Composite risk scores have been used for decades to identify disease risk and health status in the general population. However, current approaches often fail to identify people who would benefit from intervention or recommend unnecessary intervention. Machine learning promises to improve accuracy, ensuring targeted treatment for patients that need it and reducing unnecessary intervention. Framingham Risk Score, the gold standard for predicting the likelihood of heart disease, predicts hospitalizations with about 56% accuracy. It uses factors such as age, gender, smoking, cholesterol levels, and systolic blood pre...
Source: MDDI - November 17, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: R & D Source Type: news

New tool predicts risk of heart attack in older surgery patients
FINDINGSA tool designed to more accurately predict the risk of heart attack in older patients undergoing non-cardiac surgery works significantly better than traditional risk assessment tools. By having more accurate information, older patients and their physicians can make an informed decision on whether to undergo surgery, UCLA researchers concluded.BACKGROUNDIn adults who undergo inpatient surgery, the mortality rate for those patients who experience cardiac arrest after surgery is 65 percent, and is about 15 to 25 percent for those who have a heart attack. Estimating the risk of cardiac complications is an important ste...
Source: UCLA Newsroom: Health Sciences - November 16, 2017 Category: Universities & Medical Training Source Type: news

NYPD Honors Flores for Work with Asbestos-Related Diseases
New York City Police Commissioner James O’Neill recently appointed mesothelioma specialist Dr. Raja Flores to the Society of Honorary Police Surgeons. The prestigious appointment stems from Flores’ continued, long-running service to so many first responders — particularly policemen and firemen from the 9/11 World Trade Center (WTC) terrorist attack in 2001. Although Flores has received many honors throughout his medical career, this one might be his most appreciated. “This is a huge honor for me,” Flores told Asbsetos.com. “I come from a family of cops. Police work is in my blood. My gra...
Source: Asbestos and Mesothelioma News - November 13, 2017 Category: Environmental Health Authors: Daniel King Tags: 9/11 9/11-related cancer James O’Neill Mount Sinai Hospital New York City Police Commissioner NYPD Raja Flores Society of Honorary Police Surgeons twin towers World Trade Center World Trade Center Health Program Source Type: news

Older donor lungs should be considered for transplantation
(Elsevier) With a scarcity of lungs available for transplantation, the use of lungs from donors older than age 60 has been shown to achieve reasonable outcomes and should be considered as a viable option, according to research published online today in The Annals of Thoracic Surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 9, 2017 Category: International Medicine & Public Health Source Type: news

Senate Introduces Latest Attempt to Ban Asbestos
U.S. Sen. Jeff Merkley, D-Ore., introduced legislation in Congress this week that would effectively ban all use of asbestos. The Alan Reinstein Ban Asbestos Now Act of 2017 is the sixth legislative attempt to ban the toxic substance in the last 20 years. All previous bills failed to gain enough support. While the 2016 Toxic Substances Control Act (TSCA) already includes asbestos on its top ten chemicals for risk review by the Environmental Protection Agency (EPA), Merkley’s legislation could speed the process considerably. What Would the Bill to Ban Asbestos Do? According to Merkley’s congressional office, the ...
Source: Asbestos and Mesothelioma News - November 8, 2017 Category: Environmental Health Authors: Daniel King Tags: Alan Reinstein Ban Asbestos Now Act asbestos ban Cory Booker environmental protection agency EPA Jeff Merkley Jon Tester Raja Flores Steve Daines Toxic Substances Control Act TSCA u.s. congress Source Type: news

Abbott Scores Japan Approval for MitraClip
Patients in Japan who previously had limited options for mitral regurgitation (MR) can potentially benefit from Abbott's MitraClip device. Japan's Ministry of Health, Labour, and Welfare (MHLW) has approved the catheter-based therapy for MR, a progressive heart disease in which the mitral valve does not close properly, allowing blood to flow backward into the heart. During Abbott's third-quarter earnings call, as transcribed by Seeking Alpha, CEO Miles White told investors that a continued global uptick of MitraClip sales led double-digit growth in the structural heart category. Now that the device has been approved in Jap...
Source: MDDI - November 6, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Japan clears Abbott ’ s Mitraclip
Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation. Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added. The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Abbott Source Type: news

Intuitive is Giving Thoracic Surgeons Something to Talk About
Results from the first clinical study assessing the safety and performance of Intuitive Surgical's new flexible robotics platform were released this week at the CHEST annual meeting. The findings suggest that the surgical platform is both safe, and provides a practical approach for sampling lung tissue. The study was carried out at Australia’s Royal Brisbane and Women’s Hospital where the platform was used on 30 different patients to evaluate both the safety and feasibility of the surgical system. The new system is a catheter-based technology that was designed to access some of the more difficult-to-reach areas...
Source: MDDI - November 3, 2017 Category: Medical Devices Authors: Kristopher Sturgis Tags: R & D Source Type: news

Patient on a mission to help others after spine surgery
When Marichu Rosales Brun, 17, began experiencing numbness in her upper right thigh almost two years ago, the teenager knew something was wrong. After visits to doctors near in her home of Colima, Mexico, the family learned Marichu had a thoracic spinal mass that threatened her mobility. In August 2016, the family connected with Mayo [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - November 2, 2017 Category: Databases & Libraries Source Type: news

TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver. Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT. One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group ana...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Surgeon sues J & J ’ s DePuy in royalties dispute
A surgeon who helped Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes Spine develop instruments and implants for spine procedures wants a Massachusetts federal court to overturn an arbitrator’s ruling that the company doesn’t owe royalties on the products, according to a lawsuit filed last week in the Bay State. Dr. Carl Lauryssen and his company, Jordan Consulting, helped develop the Mountaineer OCT spinal system and thethe C1 drill guide for occipito-cervico-thoracic spinal fusion procedures. The parties inked the development deal in 2003, but by November 2014 the arrangement had soured, le...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Orthopedics Spinal depuysynthes jordanconsulting Source Type: news

Successful cardiogenic shock treatment using a percutaneous left ventricular assist device
(Osaka University) The Cardiovascular Surgery Group at Osaka University succeeded in minimally invasive treatment of a patient with acute heart failure due to medical treatment-resistant cardiogenic shock by making use of Impella, a percutaneous auxiliary artificial heart, for the first time in Japan. This method is anticipated as a new therapy for treating patients with acute heart failure due to medical treatment-resistant cardiogenic shock. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 31, 2017 Category: International Medicine & Public Health Source Type: news

TCT 2017: Abbott ’s Xience coronary stent helps patients feel better faster than open-heart surgery
Abbott (NYSE:ABT) reported today that patients who were treated with the company’s Xience coronary stent for left-main coronary artery disease felt better faster compared to patients who had open-heart surgery. The data were presented at this year’s Transcatheter Cardiovascular Therapeutics meeting during a late-breaking session. “For any treatment, it’s important to not only consider clinical outcomes such as recurrent heart attacks or stroke, but also to consider the effect of the treatment on a patient’s quality of life,” study investigator Dr. Suzanne Baron said i...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Surgical Wall Street Beat Abbott Source Type: news

Afternoon open heart surgery 'leads to fewer complications'
Conclusion This study found evidence of an effect that's worth investigating further to see if there are real differences in heart muscle function and risk of complications from heart surgery at different times of the day. However, there were some limitations: It took place at a single hospital, with a relatively small number of people undergoing operations. The laboratory study found differences in gene activity that suggested the body clock may play a role in making the heart better able to tolerate loss of oxygen and subsequent re-oxygenation. However, there may be other explanations for these differences. For example, ...
Source: NHS News Feed - October 27, 2017 Category: Consumer Health News Tags: Heart/lungs Source Type: news

More early stage lung cancer patients survive the disease
(Elsevier) With the advancement of surgical and radiation therapy strategies for stage 1 non-small-cell lung cancer (NSCLC), more patients are being treated, resulting in higher survival rates, according to a study published online today in The Annals of Thoracic Surgery. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - October 26, 2017 Category: Cancer & Oncology Source Type: news

Courtney ’s story: Piecing together a genetic puzzle
Courtney Whitmore was born 22 years ago with a cleft palate, two clubbed feet and fists that were so tightly clenched they couldn’t be pulled apart. Since Courtney was an otherwise happy and healthy baby, neither her parents nor her doctor saw cause to be concerned about these seemingly unrelated conditions. What they didn’t realize was that these were the first clues to a genetic puzzle that would take ten years to unravel. The next clue came at age 3. “One day my dad and I were playing peekaboo, and suddenly I couldn’t see,” says Courtney. “My parents rushed me to the hospital and the ...
Source: Thrive, Children's Hospital Boston - October 25, 2017 Category: Pediatrics Authors: Ellen Greenlaw Tags: Diseases & Conditions Our Patients’ Stories brain aneurysm Cardiovascular Genetics Program Cerebrovascular Surgery and Interventions Center Dr. Darren Orbach Dr. Lawrence Karlin Dr. Pedro del Nido Dr. Ronald Lacro Loeys-Dietz syndrome Source Type: news

Feinstein Institute study looks at impact of a popular pre-heart transplant therapy on the kidney
(Northwell Health) Scientists, nephrologists and cardiac surgeons from The Feinstein Institute for Medical Research and Northwell Health's Department of Internal Medicine, Cardiology and Cardio-Thoracic Surgery examined the impact of a popular pre-heart transplant therapy on the kidney in a study published today by The Clinical Journal of the American Society of Nephrology. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 25, 2017 Category: International Medicine & Public Health Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints ...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

7 medtech stories we missed this week: Oct. 20, 2017
[Image from unsplash.com]From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD inks Chile distribution deal InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime Embolic Protection System (EPS). The MGuard Prime EPS treats acute coronary syndromes like acute myocardial infarctions. 2. Medacta launches MiniMed hip stem Medacta has launched its MiniMAX Hip System in the U.S., according to an Oct. 12 press relea...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Implants Orthopedics Patient Monitoring Regulatory/Compliance Surgical Ultrasound Esaote Hill-Rom Holdings Inc. Honeywell InspireMD Medacta Source Type: news

These 7 antique medical devices will make you shudder
[Image from Karen Newman on Flickr]It’s a good thing we live in the times of modern medicine. Since the early days of medical devices, there have been some scary, unorthodox and quackery medical devices. Surprisingly, a lot of these devices were thought to be useful in their era – long before the government started regulating devices (which wasn’t until the 1900s). The FDA has had to intervene with a lot of these devices from the 17th to 20th centuries if they didn’t already become obsolete from public skepticism. You may have heard of the Relaxacizor, but what about dairy pumps and beer hoses ...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blood Management Cardiac Assist Devices Cardiovascular Cosmetic/Aesthetic Dental Diagnostics Food & Drug Administration (FDA) Hospital Care Imaging Laboratory Instruments/Laboratory Supplies Neurological Regenerative Medicine antiq Source Type: news

Spearheading Advancements in Surgical Sealants
Surgeons and clinicians have used surgical sealants for closing or reconnecting ruptured tissues, or as an adjunct to sutures and staples, for years. However, advancements in technology have led general surgeons and specialists to consider sealants for a wider range of applications and with increased frequency. Increasing Ease of Use Surgical sealants aren't as easy to use as a tube of Crazy Glue. Surgeons must mix and use some agents precisely and promptly to be effective. Delivery systems vary from a syringe, proprietary applicator, or through an endoscope. Most require special training. Sylys®, an elastic, resorbabl...
Source: MDDI - October 13, 2017 Category: Medical Devices Authors: Heather R. Johnson Tags: Implants Source Type: news

Boston Scientific, Mayo Clinic file joint patent for self-centering TAVR cath
Boston Scientific (NYSE:BSX) and the Mayo Clinic recently filed a joint patent application for a new ‘self-centering’ catheter device as a result of a collaborative development deal the two announced last March, according to a Twin Cities Business Magazine report. The new device is being designed to help improve heart valve replacement surgery by improving the process of threading guide wires through shrunken and often times shifted aortic valve openings in calcified hearts, according to the report. Currently, surgeons must probe along the surface of the valve with the guide wire to find the opening, ...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Replacement Heart Valves Research & Development Boston Scientific Mayo Clinic Source Type: news

Russian study pits InspireMD ’ s CGuard device against Abbott ’ s Rx Acculink carotid stent
InspireMD (NYSE:NSPR) this week touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT). The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research Institute of Circulation Pathology in Novosibirsk, the study is led by Dr. Andrei Karpenko. The primary endpoint is new ischemic areas in the brain 24 to 48 hours post-procedure and new lesi...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Stents InspireMD Stroke Source Type: news

Did CryoLife & #039;s Revenue Miss Overshadow Its Big Deal?
CryoLife has struck a $225 million cash-stock deal that is expected to boost the company’s growth prospects, but the news was not enough to buoy shareholder confidence in the company's stock on Wednesday. The plans to acquire Jotec, a German company that makes endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. CryoLife also reported a third-quarter revenue miss by about $2 million, which was largely attributable to recent hurricanes in Texas and Florida. The company's shares [NYSE: CRY] dropped 14.16% ($3.30) Wednesday to close at $20. "We believe t...
Source: MDDI - October 11, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Cardiovascular Source Type: news

Aggressive Mesothelioma Surgery Benefits More Patients
Patients diagnosed with the worst cases of pleural mesothelioma could benefit the most from the aggressive surgery they often are denied, according to one recent study. The findings have raised questions about the restrictive surgery selection process at many specialty centers handling mesothelioma, the rare and aggressive cancer caused by asbestos exposure. “In some cases, patients are not being offered the aggressive surgery that could help their quality of life,” lead author Dr. Wickii Vigneswaran, mesothelioma specialist and chief of thoracic surgery at the Loyola University Medical Center, told Asbestos.co...
Source: Asbestos and Mesothelioma News - October 11, 2017 Category: Environmental Health Authors: Matt Mauney Tags: Aggressive Mesothelioma Surgery asbestos exposure Dr. Wickii Vigneswaran epithelial mesothelioma epithelioid histology extrapleural pneumonectomy Loyola mesothelioma program Loyola University Medical Center mesothelioma Chicago mesotheli Source Type: news

Medtronic breaks ground on western China Innovation Center
Medtronic (NYSE:MDT) said today it has begun work on an Innovation Center in Chengdu, China, slated to open in 2020. The new Chengdu Innovation Center is being built at the Singapore-Sichuan Hi-Tech Innovation Park in the Sichuan Province and aims to provide clinical training and research platforms for medical workers in the region and neighboring regions. “Medtronic understands the critical role that rural physicians play in driving the healthcare availability and transformation. As such, we hope to support the growth and development of medical workers in China’s vast central and western regions, help the...
Source: Mass Device - October 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Medtronic Source Type: news

Amit Taggarse Joins Cardiac Team at Mercy (NWA Movers & Shakers)
Dr. Amit Taggarse has joined Mercy Clinic Cardiovascular & Thoracic Surgery in Fort Smith. He recently completed fellowships in advanced adult cardiac surgery, mechanical circulatory support and heart transplantation at the Mayo Clinic in Rochester, Minnesota. (Source: Arkansas Business - Health Care)
Source: Arkansas Business - Health Care - October 9, 2017 Category: American Health Source Type: news

5 pounds of THIS in your body?
Did you know that by the time you’re 50, you could have almost five pounds of toxins trapped inside your cells, tissue and organs? For millions of years, we had clean air and pure water. But in the past hundred years, our environment has changed faster than we can evolve with it. We weren’t designed to live in a modern world of manmade chemicals, toxins and pollutants. That’s why purging your body of pollutants is more important today than ever. Environmental toxins have become a major health threat. These toxins have linked with many of today’s chronic diseases including: • Cancer • Di...
Source: Al Sears, MD Natural Remedies - October 5, 2017 Category: Complementary Medicine Authors: Al Sears Tags: Anti-Aging Source Type: news

“Quackery” that saves lives
I’m used to being a target of mainstream medicine. I can’t even count the number of times I’ve been called a “quack.”  Let me give you just one example… For decades I’ve been treating my patients with a proven therapy. The FDA approved it way back in 1953. I use it to help my patients detox from mercury, lead, cadmium and other heavy metals. In fact, more than 100,000 people get this therapy every year in the U.S. But mainstream doctors still laugh at the idea of this treatment and think it’s pure bunk. I’m talking about intravenous (IV) chelation. Even though I...
Source: Al Sears, MD Natural Remedies - October 5, 2017 Category: Complementary Medicine Authors: Randall Hall Tags: Anti-Aging Health Heart Health Men's Health Women's Health Source Type: news

Brookwood Baptist surgeon receives coveted heart surgery fellowship
A Brookwood Baptist Health surgeon has received a coveted national fellowship and will bring a greater knowledge of heart surgery back to the Magic City. Cardiovascular and thoracic surgeon Dr. William McAlexander was selected out of 334 possible candidates for the 2017 James L. Cox Fellowship in Atrial Fibrillation Surgery, or Afib for short. "I’m honored to have the opportunity to participate in this immersive learning experience with guidance from top experts and leaders in the atrial fibrillation… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 3, 2017 Category: Biotechnology Authors: Tyler Patchen Source Type: news

Mellon Medical raises nearly $7 million for suturing tech
Dutch suturing tech company Mellon Medical said today that it has raised €6 million (equivalent to about $6.6 million) to advance its Switch instrument. Mellon Medical officials boast that their Switch single use precision-suturing instrument enables surgeons to suture tubular and layered structures about twice as fast as conventional methods. Reduced clamp time for many cardiovascular procedures equals reduced complications risk, better patient outcomes and reduced costs, according to the company. “By collaborating with medical specialists, industrial designers and ergonomic experts in the development...
Source: Mass Device - October 2, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well mellonmedical surgery Source Type: news

Surgery Bests Transcatheter Repair for Paravalvular Leaks (CME/CE)
(MedPage Today) -- But higher technical success comes at the cost of more in-hospital adverse events (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - October 2, 2017 Category: Cardiology Source Type: news

Medtrobotics submits FDA application for transabdominal robotic scope
Medrobotics said today it submitted an application to the FDA as it seeks clearance for a flexible transabdominal robotic scope designed to visualize anatomy in the thoracic and abdominal cavities. The Raynham, Mass.-based company produces the Flex robot-assisted surgery platform, which is designed for transoral, colorectal and other minimally invasive procedures. The company touts the system as the 1st to offer minimally invasive and steerable robotic products for colorectal applications. Medrobotics said that the submission reaffirms its “commitment to develop products for single-port general, gynecological and uro...
Source: Mass Device - September 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Robotics Medrobotics Source Type: news

Early Adopters of REBOA Prefer It to Emergency Thoracotomy
(MedPage Today) -- Procedure mainly performed by surgeons without formal endovascular training (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 27, 2017 Category: Cardiology Source Type: news

Viseon Spine closes $5m Series A round
New medical device company Viseon Spine closed its $5.0 million Series-A financing to fund product development, regulatory approvals, clinical evaluations and manufacturing and commercialization efforts, the company announced today. HBM-MedFocus, Invus Opportunities Fund and affiliates of Wexford Capital LP led the financing round. “We are very pleased to have the support from our investment partners as we build out our proprietary technology comprised of state-of-the-art visualization and illumination technologies for use in minimally invasive spine surgery (MISS) procedures,” president and CEO Jeffrey Valko s...
Source: Mass Device - September 26, 2017 Category: Medical Devices Authors: Alex Beall Tags: Business/Financial News Funding Roundup Spinal Surgical Viseonspine Source Type: news

LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae
LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae. The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles. Optiflow Arterial cannulae have a “basket tip with large openings,” LivaNova reported, which has been shown to significantly reduce wall shear stress and turbulence. This feature could help lessen ischemic complications from extracorporeal circulation during cardiac surgery, the compan...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat LivaNova Source Type: news

Transcatheter heart valve surgery simulator dev FEops raises $7m
Surgical simulation software developer FEops said today it raised $7.2 million (EU €6 million) in funding to support its HeartGuide transcatheter valve implantation simulation software. The round was led by newly invested Valiance and joined by existing investors Capricorn and PMV, the Gent, Belgium-based company said. FEops’ flagship product is the HeartGuide platform, which use advanced computer simulations to provide both clinicians and valve manufacturers with insights into the interaction between valves and patient anatomy preoperatively to improve clinical outcomes, the company claims. “The shift tow...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Software / IT Surgical feops Source Type: news

Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve ...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Investors seek class action status in lawsuit over St. Jude implantable defib batteries
Abbott (NYSE:ABT) is facing an investor suit from an Alaskan union-benefits fund over allegations that St. Jude Medical, which it closed its acquisition of in January, failed to notify regulators about defective lithium batteries in its implantable defibrillators. In the lawsuit, plaintiffs allege that St. Jude was informed of the battery defect “as early as 2011”, but it failed to take action and would wait 5 years before issuing a recall for the devices. St. Jude received 42 product reports which showed “evidence of premature battery depletion due to lithium cluster bridging,” court documents...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Legal News Abbott stjudemedical Source Type: news

Carotid Interventions Dropping for Seniors
(MedPage Today) -- Both stenting and surgery declined since 2007 but outcomes improved (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 19, 2017 Category: Cardiology Source Type: news

Mesothelioma Clinical Trials Involve Gene Therapy
Treatment options for malignant mesothelioma may soon include customized gene therapy, according to thoracic surgeon and scientist Dr. Prasad Adusumilli at Memorial Sloan Kettering Cancer Center in New York. Gene therapy involves a laboratory reprogramming of a patient’s own T cells, which are a type of white blood cell, to recognize and destroy the cancer. The U.S. Food and Drug Administration (FDA) recently approved the first gene therapy specifically for pediatric leukemia, signaling the start of a new approach to cancer treatment in this country. The newly approved treatment is also known as chimeric antigen rece...
Source: Asbestos and Mesothelioma News - September 19, 2017 Category: Environmental Health Authors: Matt Mauney Tags: CAR T cell therapy checkpoint blockade chimeric antigen receptor T cell therapy Dr. Andy Haas Dr. Prasad Adusumilli Dr. Scott Gottlieb FDA Commissioner gene therapy cancer gene therapy for mesothelioma immunotherapy clinical trial mali Source Type: news

Pearls from: Samar Hafida, MD
(MedPage Today) -- Metabolic surgery is a viable treatment option for type 2 diabetes (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 19, 2017 Category: Cardiology Source Type: news

HRS releases CIED lead extraction guidelines
The Heart Rhythm Society this week released its guidelines on device lead management and extraction for implantable cardiovascular electronic devices. The new guidelines are the result of a collaboration amongst 10 international organizations, according to the HRS. Included contributing organizations are the HRS, American College of Cardiology, American Heart Association, Asia Pacific Heart Rhythm Society, American Society of Anesthesiologists, European Heart Rhythm Association, Infectious Diseases Society of America, Latin American Hearth Rhythm Society, Pediatric and Congenital Electrophysiology Society and the Society o...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Heart Rhythm Society Source Type: news

VIDEO: Magovern honored with Health Care Heroes career achievement award (Video)
Dr. George Magovern Jr. received a career achievement award during the Health Care Heroes Awards ceremony, which was held Thursday night at the Omni William Penn Hotel downtown. Magovern is one of the country's most renowned cardiac surgeons. He is chairman of the Department of Thoracic and Cardiovascular Surgery for Allegheny Health Network. The Pittsburgh Business Times' 2017 Health Care Heroes Career Achievement Award honored his commitment to quality health care in th e region and a career filled… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 15, 2017 Category: American Health Authors: Richard Cerilli Source Type: news

LivaNova heater-cooler implicated in infections in 12 pediatric heart surgery patients
A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report. A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients with infections identified through phone calls to families. A number of patients who have only received phone calls are slated to see doctors this week, leaving the possibility that the numbers will grow, STAT reports. The hospital has since replaced the contaminated ...
Source: Mass Device - September 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Surgical LivaNova Source Type: news

AtriCure launches AtriClip Pro-V in the US
AtriCure (NSDQ:ATRC) said today it launched its AtriClip Pro-V left atrial appendate exclusion system in the US. The newly launched AtriClip Pro-V is designed to be placed through a minimally-invasive surgery and features an open-ended design and tip-first closure mechanism for easier navigation, the Mason, Ohio.-based company claims. “Development of the AtriClip Pro-V is another step in the direction of a comprehensive strategy for management of the left atrial appendage. It expands the options for minimally invasive approaches including right chest access and an easier implantation of an epicardial atrial appe...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves AtriCure Inc. Source Type: news

Even Mild Secondary Mitral Regurgitation Tied to Reduced Survival
(MedPage Today) -- Unclear if surgery, transcatheter procedures are better than medical therapy for valve disease (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 8, 2017 Category: Cardiology Source Type: news