Urgent pulmonary lobectomy for blunt chest trauma: report of three cases without mortality - Chiarelli M, Gerosa M, Guttadauro A, Gabrielli F, Vertemati G, Cazzaniga M, Fumagalli L, De Simone M, Cioffi U.
BACKGROUND: The majority of patients with severe blunt chest trauma is successfully treated with supportive measures and thoracostomy tube; only few cases need urgent thoracotomy. Lung-sparing techniques are treatments of choice but major pulmonary resecti... (Source: SafetyLit)
Source: SafetyLit - August 13, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
TAVR: Study shows benefit of Claret Medical ’ s Sentinel cerebral protection device
A study released this week reported that the use of Claret Medical‘s cerebral protection device during transcatheter aortic valve implantation procedures in patients with severe aortic stenosis can reduce the number and volume of brain lesions.
The study, which received funding from Claret and Medtronic (NYSE:MDT), was published in the August 9 issue of the The Journal of the American Medical Association.
“First, as other studies have noted, emboli to the brain that cause infarction detected on MRI are very common with TAVI. In this trial, acute lesions on MRI were present in virtually all patients enrolled, a...
Source: Mass Device - August 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Cardiovascular Catheters Clinical Trials Claret Medical Inc. Source Type: news
AtriCure launches cryoanalgesia study
This study is designed to provide further clinical and scientific evidence,” CEO Michael Carrel said in a press release.
The study plans to include patients undergoing unilateral thoracotomy cardiac procedures, and will evaluate pain scores and lung function recovery during hospital stays post-procedure, Atricure said.
The primary objective of the study is to analyze whether intercostal cryoanalgesia with the CryoIce device along with standard of care paint management provides improved analgesic efficacy and a quicker, more complete recovery for patients undergoing unilateral thoracotomy cardiac procedures when comp...
Source: Mass Device - June 21, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Pain Management AtriCure Inc. Source Type: news
Tisherman Presents Treatment Options for Exsanguinating Patients in Cardiac Arrest at EMS Today 2016
For patients who suffer a cardiac arrest from exsanguinating blood loss, survival rate is only 5–10%, even with rapid, advanced prehospital care, fluid resuscitation, and an emergency department thoracotomy. In his clinical session titled Saving Exsanguinating Trauma Patients with Hypothermia and Cardiopulmonary Bypass, which was held Friday, Feb. 26 at EMS Today 2016, Sam Tisherman, MD, said, “CPR just doesn’t work for trauma.” Because of these dismal results, guidelines for withholding or discontinuing resuscitative efforts in such patients have been developed and adopted by many EMS agencies.
Dr. Peter Safar, kn...
Source: JEMS: Journal of Emergency Medical Services News - February 27, 2016 Category: Emergency Medicine Authors: JEMS Staff Tags: News EMS Today Source Type: news
HeartWare takes another hit despite Q4, 2015 beats
HeartWare International (NSDQ:HTWR) shares took another hit today despite 4th-quarter results that topped expectations on Wall Street, as investors reacted to lower-than-expected sales volume overseas.
Fourth-quarter losses grew 1.1% to $-926,000, or -5¢ per share, for Framingham, Mass.-based HeartWare, which makes implantable heart pumps. Sales were off -7.0% to $68.1 million, compared with Q4 2014. Adjusted to exclude 1-time items, earnings per share were -53¢, a full 21¢ ahead of The Street, where analysts were looking for sales of $67.9 million.
Full-year losses surged 275.8% to -$72.8 million, or -$4.21 per share, ...
Source: Mass Device - February 25, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular MassDevice Earnings Roundup Wall Street Beat HeartWare International Inc. Source Type: news
HeartWare plunges on extended pause for MVAD trial
Investors have pared 30.0% from HeartWare International (NSDQ:HTWR) since the company said yesterday that it may not be able to resume a trial of its MVAD implantable heart pump next month, as was expected.
Framingham, Mass.-based HeartWare, which put a hold on enrollment in its CE Mark trial Sept. 9 due to controller manufacturing and software issues, said it began investigating reports of adverse events in certain trial subjects, but didn’t explain the nature of the events other than to say that they’re “typical of those seen in other clinical trials for ventricular assist devices.”
“Alth...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials HeartWare International Inc. Source Type: news
HeartWare pauses MVAD trial
HeartWare International (NSDQ:HTWR) today said it’s pausing enrollment in a clinical trial of its next-generation MVAD heart pump while it looks to fix an issue with the manufacturing process for the left ventricular assist device’s controller.
Framingham, Mass.-based HeartWare said none of the MVADs in the study are involved in the controller manufacturing issue, which does not affect the performance of the pump.
The prospective, non-randomized, single-arm study, launched in July, is slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint ...
Source: Mass Device - September 9, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Food & Drug Administration (FDA) HeartWare International Inc. Source Type: news
Resuscitative thoracotomy for pediatric trauma in Illinois, 1999 to 2009 - Nicolson NG, Schwulst S, Esposito TA, Crandall ML.
BACKGROUND: Outcomes in adults who undergo resuscitative thoracotomy are poor. Few studies have examined the procedure's use in pediatric trauma. METHODS: The Illinois State Trauma Registry was queried for thoracotomy performed in the emergency dep... (Source: SafetyLit: All (Unduplicated))
Source: SafetyLit: All (Unduplicated) - August 7, 2015 Category: Global & Universal Tags: Age: Infants and Children Source Type: news
MassDevice.com +3 | The top 3 medtech stories for July 20, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. HeartWare launches European trial for next-gen MVAD heart pump
HeartWare International said that it’s launching a clinical trial aimed at winning CE Mark approval in the European Union for its next-generation MVAD implantable heart pump.
The prospective, non-randomized, single-arm study ...
Source: Mass Device - July 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
HeartWare launches European trial for next-gen MVAD heart pump
HeartWare International (NSDQ:HTWR) said today that it’s launching a clinical trial aimed at winning CE Mark approval in the European Union for its next-generation MVAD implantable heart pump.
The prospective, non-randomized, single-arm study is slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at 6 months, HeartWare said.
The 1st patients in the trial were implanted at the Freeman Hospital in Newcastle upon Tyne, England, and the Medical University AKH Vienna, Framingham, Mass.-based HeartWare said.
The company is chasing a...
Source: Mass Device - July 20, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials HeartWare International Inc. Thoratec Corp. Source Type: news
MassDevice.com +3 | The top 3 medtech stories for July 7, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Tilting Capital plans reverse merger with ArcScan
Canadian venture group Tilting Capital said that it’s planning a reverse merger with Golden, Colo.-based ophthalmic imaging device developer ArcScan.
Tilting Capital said it agreed to put up about $7.2 million (Cdn $9.2 million) worth of ...
Source: Mass Device - July 7, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Thoratec touts less-invasive HeartMate 3 implantation
Thoratec (NSDQ:THOR) yesterday revealed the 1st implantation of its next-generation HeartMate 3 implantable heart pump using a mini-thoracotomy approach.
The implantation, part of a European trial designed to examine less-invasive procedures such as hemi-sternotomy and left thoracotomy, was the 1st of a planned 10 surgeries, Pleasanton, Calif.-based Thoratec said.
“This achievement marks the latest step in our progress with HeartMate 3, and will help build important clinical experience as we validate the surgical versatility of this exciting new technology,” president & CEO Keith Grossman said in prepa...
Source: Mass Device - July 7, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Thoratec Corp. Source Type: news
Mesothelioma Survivors Endorse Baylor's Lung Institute in Houston
Thoracic surgeon Dr. David Sugarbaker disappointed some patients in 2014 when he left Brigham and Women's Hospital in Boston, where he had forged his reputation as the nation's foremost authority on the treatment of malignant pleural mesothelioma.
The Lung Institute at Baylor College of Medicine in Houston now is Sugarbaker's new home. There, he continues to build a comprehensive, multidisciplinary program that caters to cancer patients with mesothelioma.
His departure, though, has been a godsend for others – particularly two patients who needed him in Texas.
"Sometimes God answers prayers in strange ways," said Sydney R...
Source: Asbestos and Mesothelioma News - February 17, 2015 Category: Environmental Health Authors: Tim Povtak Tags: Treatment & Doctors Source Type: news
HeartWare beats on Q4 prelims, launches thoracotomy trial
HeartWare International's preliminary sales numbers for the 4th quarter beat expectations as it launches a thoracotomy trial for its implantable heart pump.
HeartWare International Inc.News Well, Clinical Trials, MassDevice.com Earnings Roundup, 2014, Cardiac Assist Devices, Q4read more (Source: Mass Device)
Source: Mass Device - January 13, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news
Thoracotomy in Blunt Trauma: What's the Harm?Thoracotomy in Blunt Trauma: What's the Harm?
Thoracotomy is often a last-ditch effort when trying to resuscitate a patient who has suffered trauma. What are risks vs benefits of attempting this procedure? Medscape Emergency Medicine (Source: Medscape Emergency Medicine Headlines)
Source: Medscape Emergency Medicine Headlines - December 12, 2014 Category: Emergency Medicine Tags: Emergency Medicine Viewpoint Source Type: news
