Medtronic wins expanded FDA nod for SelectSure pacing leads
Medtronic (NYSE:MDT) said today it won expanded FDA labeling for its SelectSecure MRI SureScan model 3830 cardiac pacing leads, now approved for His-bundle pacing.
The Fridley, Minn.-based company said its bipolar, steroid-eluting SelectSecure leads are designed to be attached to a single or dual chamber pace maker and are now approved for pacing and sensing in the atrium, right ventricle or at the bund of HIS as an alternative to right ventricular placing.
Medtronic said it also offers a C315HIS deliver catheter for placing leads at or near the His bundle.
“There is growing interest among some physicians in His-bun...
Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news
Medtronic ’s HVAD System Just Became Less Invasive
Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016. The firm said the technology is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest.
FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for ...
Source: MDDI - July 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
FDA Approves HeartWare LVAD for Implant via Thoracotomy FDA Approves HeartWare LVAD for Implant via Thoracotomy
Implanting Medtronic ' s HeartWare ventricular assist device via the less invasive approach was shown to be safe and effective in the LATERAL clinical trial.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 11, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news
Medtronic wins FDA nod for thoracotomy-based HVAD procedure
Medtronic (NYSE:MDT) said today it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach.
The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device.
The 44-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news
REBOA: The Next Stop on the Road to Trauma Management?
The management of major trauma has a long history of failures found along a road of good intention. From Military Anti-Shock Trousers (MAST) to aggressive crystalloid administration, we’ve seen management strategies come and go over the years, after the reality of the practice didn’t measure up to the expectation of improved outcomes.
Today, we have several novel concepts being implemented across the world to try to move the needle for trauma resuscitation. Tranexamic acid (TXA), blood product administration, and simple (finger) thoracostomy are a few of the advances that seem to be gaining interest in EMS. Although th...
Source: JEMS Special Topics - July 5, 2018 Category: Emergency Medicine Authors: Mark E.A. Escott, MD, MPH, FACEP, NRP Tags: Trauma Exclusive Articles Columns Source Type: news
VATS Proves Mettle in Early-Stage NSCLC
(MedPage Today) -- Survival at least similar to open thoracotomy (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - June 28, 2018 Category: Primary Care 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
Survival after emergency department thoracotomy in the pediatric trauma population: a review of published data - Moskowitz EE, Burlew CC, Kulungowski AM, Bensard DD.
BACKGROUND/PURPOSE: The utility of EDT in the adult trauma population, using well-defined guidelines, is well established, especially for penetrating injuries. Since the introduction of these guidelines, reports on the use of EDT for pediatric trauma have ... (Source: SafetyLit)
Source: SafetyLit - June 11, 2018 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
Abbott Gains on Medtronic in LVAD Market
Abbott Laboratories said late-breaking clinical trial data from its MOMENTUM 3 clinical study shows its HeartMate 3 Left Ventricular Assist Device (LVAD) has improved survival and lowered rates of stroke and pump thrombosis.
The Abbott Park, IL-based company released the data during the American College of Cardiology’s 67th Annual Scientific Sessions this past weekend.
Data from MOMENTUM 3 was also published in the New England Journal of Medicine and showed patients with the HeartMate 3 LVAD had a survival rate of 82.8% at two years compared with 76.2% for those with the HeartMate II LVAD. Pump thrombosis rates remained ...
Source: MDDI - March 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
The pediatric resuscitative thoracotomy during combat operations in Iraq and Afghanistan - a retrospective cohort study - Schauer SG, Hill GJ, Connor RE, Oh JS, April MD.
BACKGROUND: Combat zone trauma poses a unique set of challenges and injury patterns not seen in the civilian setting. The role of the pediatric resuscitative thoracotomy in combat zones remains unclear given a paucity of data regarding procedure outcomes i... (Source: SafetyLit)
Source: SafetyLit - February 12, 2018 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
Medical News Today: Thoracotomy: Procedures and recovery
A thoracotomy is a type of surgery that is carried out on the chest. It is often carried out as part of lung cancer treatment or in emergency situations. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - January 16, 2018 Category: Consumer Health News Tags: Surgery Source Type: news
Cracking chests without a scratch: a review of emergency department thoracotomy outcomes and injuries to providers at a Level II trauma center - Fox SS, Martin T, Williams ZF, Hope WW.
[Abstract unavailable]
Language: en... (Source: SafetyLit)
Source: SafetyLit - October 4, 2017 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes 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
Medtronic wins EU nod for less-invasive HVAD implant procedure
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August.
The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related blood transfusions.
The newly cleared procedure could potentially reduce the development of right heart failure and could lead to shorter hospital stays, along with allowing for the area around the heart to remain largely intact to potentially ...
Source: Mass Device - November 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Regulatory/Compliance Surgical HeartWare International Inc. Medtronic Source Type: news
Making heart surgery as simple as possible with MIS techniques
Tertiary care centers such as the Boston Children’s Hospital Heart Center have led the way in groundbreaking surgical innovations for years, pushing boundaries and correcting ever more complex abnormalities.
But innovation is also making a difference when it comes to more “common” procedures.
“We’re always trying to make the less complex procedures shorter and less invasive,” says Sitaram Emani, MD, director of the Complex Biventricular Repair Program at the Heart Center. “Making surgery and recovery less painful and disruptive for all of our patients is a priority.”
Emani and his fellow cardiac surgeons h...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: Blog Vector Blog Source Type: news
