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Nov 3 Cardiology News Nov 3 Cardiology News
The ORBITA sham-control PCI study, Watchman, revascularization in cardiogenic shock, Absorb BVS, quality-of-life outcomes after PCI or bypass, and chronic total occlusion PCI are discussed in this week's podcast.theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 3, 2017 Category: Cardiology Tags: Cardiology News 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

Should patients with cardiogenic shock receive culprit lesion only PCI or multivessel PCI?
(Cardiovascular Research Foundation) Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found that an initial strategy of culprit lesion only percutaneous coronary intervention (PCI) reduces the composite of 30-day mortality and/or severe renal failure in patients with multivessel disease and cardiogenic shock complicating acute myocardial infarction. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 31, 2017 Category: International Medicine & Public Health Source Type: news

Multivessel PCI Not Best in Cardiogenic Shock
(MedPage Today) -- Trial data show mortality disadvantage versus treating culprit lesions only (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - October 30, 2017 Category: Urology & Nephrology Source Type: news

New AHA Scientific Statement on Cardiogenic Shock New AHA Scientific Statement on Cardiogenic Shock
The statement provides a management algorithm integrating medical, surgical, and mechanical circulatory support therapies and calls for the development of regionalized systems of care.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 26, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Abiomed nearly triples fiscal Q2 profits, crushes earnings expectations
Abiomed (NSDQ:ABMD) today said that its fiscal second-quarter profits nearly tripled and crushed the consensus earnings forecast on a nearly 30% sales increase. The Danvers, Mass.-based percutaneous heart pump maker posted profits of $24.5 million, or 54¢ per share, on sales of $132.8 million for the three months ended Sept. 30, for a bottom-line gain if 176.1% on sales growth of 29.0% compared with fiscal Q2 2017. Analysts on Wall Street were looking for EPS of 38¢ on sales of $131.1 million. “This quarter, we set new records for supporting patients in the U.S. and Germany and we continue to observe improv...
Source: Mass Device - October 26, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices MassDevice Earnings Roundup Wall Street Beat Abiomed Source Type: news

TCT 2017: Rich in Clinical Trials, Star Power TCT 2017: Rich in Clinical Trials, Star Power
Oscar-winner Tom Hanks headlines a conference that will feature clinical trials looking at management of left main disease, cardiogenic shock, and bioabsorbable scaffolds.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 17, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

MAUDE: Post-TAVR Leaflet Thrombosis Not Benign MAUDE: Post-TAVR Leaflet Thrombosis Not Benign
While post-TAVR leaflet thrombosis can cause valve dysfunction or even cardiogenic shock and death, the question remains whether there's justification for routine anticoagulation given its inherent risks.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 8, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Stenting Safe, More Popular for Oldest Old
(MedPage Today) -- Cardiogenic shock, no-reflow still problems in 90-year-olds (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 5, 2017 Category: Cardiology Source Type: news

Abiomed touts survival benefits in Impella 2.5 cardiogenic shock PCI treatment study
Abiomed (NSDQ:ABMD) today released results from a study of its Impella 2.5 heart pump examining the use of the device in patients with acute myocardial infarction complicated by cardiogenic shock, touting survival benefits associated with the device. Results from the Danvers, Mass.-based company’s study were published in the Journal of Interventional Cardiology. Data from the 36-patient retrospective study came from real-world outcomes with the Impella 2.5 during percutaneous coronary interventions on unprotected left main coronary arteries, Abiomed said. The study aimed to analyze whether the initiation of hemo...
Source: Mass Device - July 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Abiomed Source Type: news

The Medical Emergency Of Otto Warmbier
All that the doctors who treated Cincinnati, Ohio resident Otto Warmbier knew is what they had seen or maybe read in the news. They knew he had just been released on June 13 from imprisonment in North Korea where he had been held by for more than 17 months. He had been sentenced in March 2016 to 15 years of hard labor for allegedly removing a propaganda poster from a wall at a Pyongyang hotel where he had been staying. The University of Virginia honors student had been visiting the authoritarian state during a five-day trip with a group called Young Pioneer Tours, which is a group out of China – an important note. Ot...
Source: Healthy Living - The Huffington Post - June 22, 2017 Category: Consumer Health News Source Type: news

Datascope joins Maquet countersuit against Abiomed
Getinge‘s (PINK:GETI B) Datascope said today it is filing a motion to join fellow Getinge company Maquet‘s patent infringement case against Abiomed (NSDQ:ABMD). The Wayne, N.J.-based company said it is asserting counterclaims which allege that Abiomed engaged in false advertising to promote that its Impella device was superior to Datascope’s intra-aortic baloon pumps. Datascope said that, simultaneously, Maquet will be expanding the infringement case by alleging that most Impella models infringe upon 3 Maquet patents, bringing the total number of patents in the suit to 6. In Datascope’s counter...
Source: Mass Device - June 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement Abiomed Datascope Corp. Getinge Maquet Cardiovascular LLC Source Type: news

Suicide attempt with self-made Taxus baccata leaf capsules: survival following the application of extracorporeal membrane oxygenation for ventricular arrythmia and refractory cardiogenic shock - Vardon Bounes F, Tardif E, Ruiz S, Gallart JC, Conil JM, Delmas C.
We present a case report of a patient who attempted suicide after T. baccata... (Source: SafetyLit)
Source: SafetyLit - May 19, 2017 Category: International Medicine & Public Health Tags: Poisoning Source Type: news

Abiomed launches 3rd-gen Impella CP heart pump
Abiomed (NSDQ:ABMD) said today it launched a 3rd generation Impella CP heart pump, touting new features and improved performance with the new model. The Danvers, Mass.-based company said that the 3rd-gen device includes new features that allow for better care during percutaneous coronary interventions in high risk patients and for patients being treated with the Impella in the ICU. “The ability to introduce the Impella device simply and swiftly even in the presence of challenging femoral or iliac arteries will be valuable for interventional cardiologists caring for high-risk patients during PCI and for those in cardi...
Source: Mass Device - May 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Assist Devices Cardiovascular Abiomed Source Type: news

Abiomed dips on missed Q4 earnings, despite sales beat
Share prices for Abiomed (NSDQ:ABMD) dipped today after the company reported fiscal 4th-quarter earnings that missed expectations, despite a top-line gain of nearly 33%. The Danvers, Mass.-based heart pump maker posted profits of $14.9 million, or 33¢ per share, on sales of $124.7 million for the 3 months ended March 31, for a bottom-line increase of 35.5% on sales growth of 32.7% compared with Q4 2016. But analysts on Wall Street were looking for earnings per share of 35¢; Abiomed topped the consensus Street estimate for sales by more than $2 million. Full-year profits were $52.1 million, or $1.17 per share...
Source: Mass Device - May 4, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices MassDevice Earnings Roundup Wall Street Beat Abiomed Source Type: news

6 Variables Can Predict Mortality Risk in Cardiogenic Shock
Variables from Intraaortic Balloon Pump in Cardiogenic Shock trial ID short - term mortality risk (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - April 13, 2017 Category: Respiratory Medicine Tags: Cardiology, Internal Medicine, Critical Care, Emergency Medicine, Nursing, Pulmonology, Journal, Source Type: news

Abiomed doubles Danvers footprint
Abiomed (NSDQ:ABMD) today opened its expanded headquarters in Danvers, Mass., which more than doubles its footprint in the Bay State. Gov. Charlie Baker helped Abiomed CEO Mike Minogue and patient survivors to cut the ribbon on the $40 million, 160,000-square-foot HQ north of Boston. Abiomed makes the Impella line of percutaneous heart pumps, which are designed to provide cardiac support to heart failure patients during PCI procedures. The expansion adds new R&D and manufacturing facilities and a clinical training facility called the Heart Recovery Institute. “Today we recognize 35 years of dedication and hard wo...
Source: Mass Device - March 30, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Wall Street Beat Abiomed Source Type: news

Impella Pump Takes Positive Turn in Cardiogenic Shock Study Impella Pump Takes Positive Turn in Cardiogenic Shock Study
After the Impella heart pump showed no added benefit in cardiogenic shock over less costly balloon pumps in prior studies, applying best practices appears to be paying off with the device.Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - March 27, 2017 Category: Cardiology Tags: Cardiology News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for December 7, 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Baxter releases infusion pump programming software Baxter launched its Sigma Spectrum Safety Management System this week at the American Society of Health-System Pharmacists meeting. The infusion pump system consists of an anal...
Source: Mass Device - December 7, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA adds high-risk indication to Abiomed ’ s Impella CP heart pump
Abiomed (NSDQ:ABMD) said today that it won an expanded indication from the FDA for its Impella CP heart pump for high-risk patients. The Impella CP device, which won pre-market approval earlier this year for up to 4 hours of treating patients for cardiogenic shock after acute myocardial infarction or cardiac surgery, can now be used to for up to 6 hours during high-risk percutaneous coronary interventions, Danvers, Mass.-based Abiomed said. “This latest approval for Impella expands the hemodynamic options for the cardiovascular community to effectively revascularize severely ill patients who have limit...
Source: Mass Device - December 7, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Inc. Source Type: news

Abiomed launches quality assurance program for Impella heart pump
Abiomed (NSDQ:ABMD) said today it launched the Impella quality assurance program, looking to improve outcomes for cardiogenic shock and protected PCI patients. The Danvers, Mass.-based company said the program will use data from its IQ Database, which includes observational quality assurance data on over 95% of Impella patients since 2008, including more than 44,000 Impella case entries. The IQ program will complement best practices alongside Abiomed’s 250-person clinical field team, the company said. “Abiomed has created the largest high-risk PCI and cardiogenic shock database of real-world evidence ...
Source: Mass Device - November 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Abiomed Inc. Source Type: news

Japanese regulators approve Abiomed ’ s Impella heart pumps
Abiomed (NSDQ:ABMD) said today that it won approval from the Japanese Ministry of Health, Labor & Welfare’s Pharmaceuticals & Medical Devices Agency for its Impella line of heart pumps. The Danvers, Mass.-based company said its devices are the “1st and only percutaneous temporary ventricular support devices” to win Japanese PMDA approval and be deemed safe and effective for their indication. “This approval marks a significant milestone to provide Impella hemodynamic support for heart failure patients. We commend the dedication of Japanese physicians and regulatory bodies in se...
Source: Mass Device - September 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Regulatory/Compliance Abiomed Inc. Japanese Pharmaceuticals and Medical Devices Agency Source Type: news

A Novel Approach to the Shocky Child
  Start with three quick bedside ultrasounds and you might avoid an unnecessary IV push An 11-year-old boy is brought to your emergency department following a few hours of persistent vomiting, irritability and decreasing activity. His mother also reports about two days of fever, decreased appetite and nasal stuffness. On initial evaluation, his vital signs include a heart rate of 128 beats/minute, blood pressure of 82/64 mmHg, respirations of 24 breaths/minute and temperature of 101.50F. Pulse oximetry reveals 98% saturation on room air while capillary refill time is approximately 5 seconds. His activity is reduced an...
Source: EPMonthly.com - September 27, 2016 Category: Emergency Medicine Authors: Matt McGahen Tags: Uncategorized Source Type: news

Public Reporting for PCI, Cardiogenic Shock: Clarity or Confusion? Public Reporting for PCI, Cardiogenic Shock: Clarity or Confusion?
"It may simply be time to recognize that mortality following PCI is the wrong metric" to measure quality across diverse clinical scenarios, experts suggest.Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 11, 2016 Category: Cardiology Tags: Cardiology News Source Type: news

Abiomed posts solid Q1, lifts full year outlook
Abiomed (NSDQ:ABMD) lifted its revenue guidance for the year after posting a Street-beating 1st quarter today. The Danvers, Mass.-based company reported profits of $12.9 million, or 29¢ per share, on sales of $103 million for the 3 months ended June 30. That amounts to a healthy 45.7% bottom-line gain as sales grew 40.3% compared with the same period last year. Abiomed handily beat Wall Street analyst’s expectations of 23¢ in EPS and $97.2 million in revenue. “Abiomed is creating a new era of medicine focused on the field of heart recovery and offering new treatment paradigms for high risk heart failu...
Source: Mass Device - July 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Abiomed Inc. Source Type: news

With End of Public Reporting, Better Tx of Cardiogenic Shock in NY (CME/CE)
(MedPage Today) -- Did reporting compromise care by increasing risk aversion? (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - July 27, 2016 Category: American Health Source Type: news

A case of mushroom poisoning with Russula subnigricans: development of rhabdomyolysis, acute kidney injury, cardiogenic shock, and death - Cho JT, Han JH.
Mushroom exposures are increasing worldwide. The incidence and fatality of mushroom poisoning are reported to be increasing. Several new syndromes in mushroom poisoning have been described. Rhabdomyolytic mushroom poisoning is one of new syndromes. Russula... (Source: SafetyLit)
Source: SafetyLit - July 7, 2016 Category: Global & Universal Tags: Home and Consumer Product Safety Source Type: news

Opinion Makers: Impella for Cardiogenic Shock
(MedPage Today) -- William O'Neill, MD, on why mortality of less than 20% is "very achievable" (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 6, 2016 Category: Cardiology Source Type: news

Revascularization Strategy in Acute MI With Cardiogenic ShockRevascularization Strategy in Acute MI With Cardiogenic Shock
What is the optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by cardiogenic shock? American Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 14, 2016 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Abiomed Impella® Therapy Receives FDA Approval For Cardiogenic Shock After Heart Attack Or Heart Surgery
Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. (Source: Medical Design Online News)
Source: Medical Design Online News - April 11, 2016 Category: Medical Equipment Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 8, 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Monteris wins FDA IDE clearance for NeuroBlate trial Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy. The NeuroBl...
Source: Mass Device - April 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well 5 Source Type: news

FDA Approves Impella Heart Pumps for Cardiogenic ShockFDA Approves Impella Heart Pumps for Cardiogenic Shock
The entire family of Impella left side heart pumps has been approved for cardiogenic shock. FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 8, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news

Abiomed Adds Cardiogenic Shock to Approved Indications
(Source: MDDI)
Source: MDDI - April 8, 2016 Category: Medical Equipment Authors: mthibault Tags: News Regulatory and Legal Implantable Devices Source Type: news

FDA clears Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company. “Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of ci...
Source: Mass Device - April 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Abiomed Inc. Source Type: news

FDA approves Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company. “Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of ci...
Source: Mass Device - April 7, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Abiomed Inc. Source Type: news

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. Get this in your inbox everyday by subscribing to our newsletters.   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 MassDevi...
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 anti...
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 seiz...
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...
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 regul...
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 ...
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, ...
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 ...
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...
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