Medtronic launches DxTerity, TRA-line of radial access devices for PCIs
Medtronic (NYSE:MDT) today announced a slew of new percutaneous coronary intervention devices it added to its portfolio, including the DxTerity diagnostic angiography catheter line, the DxTerity TRA, InTRAkit transradial devices and the TRAcelet compression device.
The Fridley, Minn.-based company said all of the items have already received FDA clearance in the US and CE Mark approval in the European Union for use in diagnostic cardiac catheterization procedures and percutaneous coronary interventions.
Medtronic’s DxTerity and DxTerity TRA diagnostic catheters are designed to help determine whether revascularization...
Source: Mass Device - February 13, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Medtronic Source Type: news
Abiomed gains after Abbott tables HeartMate PHP program
Abiomed (NSDQ:ABMD) shares closed up more than 5% yesterday as investors reacted to reports that Abbott (NYSE:ABT) paused its HeartMate PHP program in Europe.
Abbott, which acquired the Thoratec line of HeartMate cardiac assist devices when it paid $25 billion for St. Jude Medical (NYSE:STJ) last month, reportedly advised physicians last week that it’s temporarily halting its Shield II clinical trial for the HeartMate PHP pump due to an issue with its catheter.
Abbott said it “temporarily paused the HeartMate PHP Shield II IDE clinical trial as well as shipment and implantation of the device for commercia...
Source: Mass Device - February 7, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat Abbott Abiomed Inc. Source Type: news
Ticagrelor More Effective Than Clopidogrel in Some Cardiac Arrest Survivors Ticagrelor More Effective Than Clopidogrel in Some Cardiac Arrest Survivors
In comatose survivors of out-of-hospital cardiac arrest undergoing percutaneous coronary intervention (PCI) and hypothermia, ticagrelor results in faster and stronger platelet inhibition compared to clopidogrel, researchers in Slovenia say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 30, 2016 Category: Consumer Health News Tags: News Source Type: news
PCI Thrombus Aspiration Might Help Some PCI Thrombus Aspiration Might Help Some
Pooled data indicate that thrombus aspiration reduces cardiovascular mortality in certain patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 27, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news
Elective Surgery Delay After PCI May Be Safely Shortened Elective Surgery Delay After PCI May Be Safely Shortened
More than a month after percutaneous coronary intervention (PCI) with a drug-eluting stent (DES), patients undergoing elective surgery appear to be at no greater risk than those without ischemic heart disease, according to Danish researchers.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 21, 2016 Category: Surgery Tags: General Surgery News Source Type: news
Endurance through criticism: The legendary career of Dr. John Simpson
Avinger executive chairman Dr. John Simpson
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!
Dr. John Simpson. Even if you’re a medical device newbie, you’ve probably heard of him. He’s credited with inventing and commercializing the first over-the-wire balloon catheter used for percutaneous transluminal coronary angioplasty (PTCA). This single idea created the field of interventional cardiology as we know it today.
Over the course of his renowned medtech career, Dr....
Source: Mass Device - December 6, 2016 Category: Medical Equipment Authors: Scott Nelson Tags: Blog Avinger medsider Source Type: news
Bayer ’s Xarelto® Significantly Reduced Bleeding Compared to VKA in AF-Patients also Receiving Antiplatelet Therapy After Percutaneous Coronary Intervention (for specialized target groups only)
PIONEER AF-PCI is the first randomised study of a non-vitamin K antagonist oral anticoagulant (NOAC) in this patient population / Data were presented in a late-breaking clinical trial session at AHA and published simultaneously in The New England Journal of Medicine (Source: Bayer Company News)
Source: Bayer Company News - November 14, 2016 Category: Pharmaceuticals Source Type: news
Phase 3b Study Shows Significantly Less Bleeding with XARELTO ® (rivaroxaban) Compared to Warfarin in People with Non-Valvular Atrial Fibrillation Following Percutaneous Coronary Intervention with Stenting
(Source: Johnson and Johnson)
Source: Johnson and Johnson - November 14, 2016 Category: Pharmaceuticals Source Type: news
Enrollment completed for RE-DUAL PCI study of 2,700 atrial fibrillation patients
(WHITECOAT STRATEGIES, LLC) The Baim Institute announces that patient enrollment into the international Phase IIIb RE-DUAL PCI study is complete. The study evaluates the safety and efficacy of dabigatran etexilate (marketed as Pradaxa ® ) in atrial fibrillation patients undergoing a percutaneous coronary intervention with stent placement. This is the first time that two dosages of a non-vitamin K antagonist oral anticoagulant already approved for stroke prevention in AF are evaluated in a dual versus triple antithrombotic regimen after PCI. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 14, 2016 Category: Global & Universal Source Type: news
Two differing medications used during heart procedure are both safe and effective, study finds
(Intermountain Medical Center) Two differing blood clot prevention medications are just as safe and effective for patients undergoing percutaneous coronary intervention, a non-surgical procedure to open blood vessels narrowed by plaque buildup, according to a new study. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 13, 2016 Category: Global & Universal Source Type: news
Results of ReACT Trial presented at TCT & published in JACC: Cardiovascular Interventions
(Cardiovascular Research Foundation) A randomized evaluation of routine follow-up coronary angiography after percutaneous coronary intervention (PCI) found that there was no long-term clinical benefit compared to clinical follow-up alone among unselected patients following PCI. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 1, 2016 Category: Global & Universal Source Type: news
Guiding coronary stent implantation
Although percutaneous coronary intervention (PCI) is most commonly guided by angiography alone, results from a new study investigating adjunctive imaging modalities showed that the use of a novel optical coherence tomography (OCT)-based stent sizing strategy results in similar minimal stent area (MSA) compared to intravascular ultrasound (IVUS)-guided PCI. Imaging-guided PCI (with both OCT and IVUS) also resulted in improved stent expansion and acute stent-based procedural success compared to angiography-guided PCI. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - October 31, 2016 Category: Science Source Type: news
Results from the NOBLE trial presented at TCT 2016 and published in The Lancet
(Cardiovascular Research Foundation) Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main coronary artery (LMCA) disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. Findings from the Nordic-Baltic-British Left Main Revascularization Study (NOBLE) trial found that despite similar mortality, the five-year risk of major adverse events was higher after PCI compared to CABG for the treatment of unprotected LMCA disease. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 31, 2016 Category: Global & Universal Source Type: news
FDA releases July 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2016
TOTAL 510(k)s THIS PERIOD 236
TOTAL WITH SUMMARIES 220
TOTAL WITH STATEMENTS 16
DEVICE: Dakin's Skin and Wound Cleanser
CENTURY PHARMACEUTICALS, INC. 510(k) NO: K150208(Traditional)
ATTN: Stephen Deardorff PHONE NO : 1 317 8494210
10377 HAGUE RD. SE DECISION MADE: 21-JUL-16
INDIANAPOLIS IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sheath Introducer
BIOTEQUE CORP. 510(k) NO: K150932(Traditional)
ATTN: Si...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
FDA releases June 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2016
TOTAL 510(k)s THIS PERIOD 258
TOTAL WITH SUMMARIES 235
TOTAL WITH STATEMENTS 23
DEVICE: ORAL BOND
STEINER LABORATORIES 510(k) NO: K142130(Traditional)
ATTN: GREGORY G STEINER PHONE NO : 866 3171348
1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16
Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QiF Blood and Fluid Warmer
Quality in Flow Ltd. 510(k) NO: K150404(Traditional)
ATTN: Neta Sherman PHONE NO : 972 54 6600146
3A Bazel ...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
