MassDevice.com +5 | The top 5 medtech stories for March 22, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. DeviceTalks Podcast: Cohera Medical CEO Patrick Daly
Before Patrick Daly was tapped as chairman of AdvaMed’s Accel unit, which represents emerging medical device companies, the CEO of Cohera Medical sat down with MassDevice.c...
Source: Mass Device - March 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Abiomed, FDA come to terms on Impella PMA requirements
Abiomed (NSDQ:ABMD) said yesterday that it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of the agency’s advisory panels.
Danvers, Mass.-based Abiomed said the federal safety watchdog agreed on the indication for treating patients in cardiogenic shock after a heart attack or cardiac surgery with its Impella 2.5, Impella CP, Impella 5.0 and Impella LD devices.
“Based on the information available to the company to date, including multiple discussions with the FDA, the company no longer anticipates ...
Source: Mass Device - March 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Inc. Source Type: news
Scorpion envenomation-induced acute thrombotic inferior myocardial infarction - Baykan AO, Gür M, Acele A, Şeker T, Çaylı M.
The occurrence of a serious cardiac emergency following scorpion envenomation has rarely been reported and, when so, mostly presented as non-ST segment elevation myocardial infarction, cardiogenic shock, or myocarditis. Possible mechanisms include imbalanc... (Source: SafetyLit)
Source: SafetyLit - March 3, 2016 Category: Global & Universal Tags: Non-Human Animals and Insects Source Type: news
Early Risk Period Seen for Survivors of Cardiogenic Shock
(MedPage Today) -- In-hospital mortality declining but a vulnerable time follows for rehospitalization, studies say (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 16, 2016 Category: Cardiology Source Type: news
Heart attack patients with cardiogenic shock fair well 60 days post-discharge
Heart attack patients who experience cardiogenic shock have a higher risk of death or rehospitalization than non-shock patients in the first 60 days post-discharge, but by the end of the first year, the gap between the two groups narrows, according to a study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - February 15, 2016 Category: Science Source Type: news
Severe bupropion overdose and ECMO: two great saves
ChaNaWiT/shutterstock.com
3.5 out of 5 stars
Two Cases of Refractory Cardiogenic Shock Secondary to Bupropion Successfully Treated with Veno-Arterial Extracorporeal Membrance Oxygenation. Heise CW et al. J Med Toxicol 2016 Feb 8 [Epub Ahead of Print]
Abstract
This awesome, exciting paper from Banner University Medical Center in Phoenix describes two teenagers with severe bupropion overdose who survived refractory cardiac arrest after veno-arterial extracorporeal membrane oxygenation (VA-ECMO):
Case 1: A 15-year-old girl was brought to hospital after ingesting up to 90 150-mg bupropion tablets. She had a seizure en route...
Source: The Poison Review - February 12, 2016 Category: Toxicology Authors: Leon Tags: Medical burpropion ECMO extracorporeal membrane oxygenation Source Type: news
Registry Finds Mounting Deaths With Cardiogenic Shock (CME/CE)
(MedPage Today) -- Worrying trend despite years of clinician experience (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - January 22, 2016 Category: Cardiology Source Type: news
Xenios expands manufacturing, R&D footprint
Xenios said today it expanded its research & development and manufacturing operations to include a new combined facility.
The Reutlingen, Germany R&D and manufacturing facility was added as the company continues on what it calls an “aggressive growth strategy.”
“Given that no other company except Xenios is offering minimally invasive lung and heart therapies on 1 platform, and given that the Xenios platform provides fundamental advantages for patients with its minimally invasive lung and heart therapies, Xenios is growing rapidly. As a direct result of the recent significant cash infusion f...
Source: Mass Device - December 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Research & Development XENiOS AG Source Type: news
Xenios wins CE Mark for I-Cor cardiac assist device
Xenios said yesterday that it won CE Mark approval in the European Union for its I-Cor synchronized cardiac assist device, touting it as the world’s 1st “heartbeat-synchronized” cardiac assist for cardiogenic shock and high-risk interventions.
Heilbronn, Germany-based Xenios, which claimed in September to have drummed up an 8-figure funding round, said the I-Cor system is designed to provide “beat-to-beat” cardiac assistance using a miniature pump “with synchronized pulses that are superimposed over the patient’s weakened heartbeats.”
“European regulatory approval o...
Source: Mass Device - November 25, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Regulatory/Compliance CE Mark XENiOS AG Source Type: news
TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer.
The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects passed the primary safety endpoint of a composite of major adverse events and the primary efficacy endpoint of freedom from hemodynamic compromise during percutaneous coronary intervention.
The study results, released today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco...
Source: Mass Device - October 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Catheters Clinical Trials Elixir Medical Corp. Micell Technologies Inc. St. Jude Medical Stentys TCT 2015 Tryton Medical Inc. Source Type: news
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
Early thrombectomy’s promise Totaled?
The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 Source Type: news
Xenios claims ‘significant’ 8-figure funding round
Lung and heart therapy device developer XENiOS AG said today it received a “significant” round of funding, claiming the amount was in the 8-figure range.
The Heilbronn, Germany-based company is developing a minimally invasive combined lung and heart therapy device on a single platform.
“No other company except XENiOS is offering minimally invasive disposable lung and heart therapies on 1 platform. The XENiOS platform provides fundamental advantages with its minimally invasive lung and heart therapies. Patients are awake and mobile. Self-determined patients facilitate improved outcomes. There is no venti...
Source: Mass Device - September 23, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Respiratory XENiOS AG Source Type: news
Case report: use of ECMO in colchicine poisoning
Colchicum autumnale (Autumn crocus)
3.5 out of 5 stars
Extracorporeal life support in the treatment of colchicine poisoning. Boisramé-Helms J et al. Clin Toxicol 2015;53:827-829.
Abstract
Colchicine toxicity occurs roughly in 3 phases. During the initial 24 hours, severe gastrointestinal symptoms — nausea, vomiting, and diarrhea — can cause hypotension and shock if fluid losses are not adequately replaced. During the second phase, severe toxicity can manifest with pancytopenia, sepsis, rhabdomyolysis, and renal failure. In addition, within days after ingestion, patients can develop cardiogenic shock and sudden cardia...
Source: The Poison Review - September 11, 2015 Category: Toxicology Authors: Leon Tags: Medical autumn crocus colchicine poisoning colchicum autumnale ECLS ECMO extracorporeal life support extracorporeal membrane oxygenation Source Type: news
Extracorporeal life support is 'bridge-to-life' for patients with sudden onset cardiogenic shock
The ideal management strategy for primary cardiogenic shock is a matter of debate. After some early discouraging experiences, the use of extracorporeal life support for patients with cardiogenic shock is having a resurgence. A report finds that patients who have an acute onset of cardiogenic shock, for example following a heart attack, and are placed on extracorporeal life support, fare better than those who have a chronic cardiac pathology. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 20, 2015 Category: Science Source Type: news
Extracorporeal life support is 'bridge-to-life' for patients with sudden onset cardiogenic shock
(American Association for Thoracic Surgery) A report from researchers in Padua, Italy finds that patients who have an acute onset of cardiogenic shock, for example following a heart attack, and are placed on extracorporeal life support, fare better than those who have a chronic cardiac pathology. In an accompanying editorial, Dr. Vivek Rao of the University of Toronto puts the findings of the study, such as a 59 percent survival to hospital discharge rate, in perspective. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 20, 2015 Category: Global & Universal Source Type: news
