Heart device and monitoring company Biotronik, has completed enrollment for its the highly anticipated IMPACT study. The study aims to investigate whether the use of Biotronik Home Monitoring® in conjunction with anticoagulation can reduce the risks of stroke, systemic embolism and major bleeding in cardiac device patients
Companies
Medtronic’s ‘IN.PACT Admiral’ Drug-Eluting Balloon Edging Towards U.S. Market
Medtronic, Inc. tells us that that enough patients have been enrolled in its clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company’s U.S. regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.
Masimo Renews $1Million Pulse Oximeter Bet To “Separate Fact From Fiction”
Masimo, the inventor of measure-through motion and low perfusion pulse oximetry today renewed its $1,000,000 guarantee that Masimo SET® Pulse Oximetry and rainbow® Pulse CO-Oximetry™ will outperform all Nellcor™ pulse oximeters, including the three that Covidien recently announced have received FDA 510(k) clearance with motion claims.
FDA Warning Letter For Edwards Lifesciences Over Quality Systems Compliance
Such are the wonders of the US financial disclosure rules, Edwards Lifesciences Corporation is compelled to tell us it has received a warning letter from the U.S. FDA resulting from an inspection of Edwards’ facility in Draper, Utah.
Medtronic’s Endurant II AAA Stent Graft System First To Only Require Uni-Iliac Access
Medtronic, Inc. is showcasing its newly approved stent graft at this weekend’s Vascular Annual Meeting, taking place in San Francisco. The company has gained FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k) clearance for the Sentrant Introducer Sheath
Deal Done As Biosensors And Spectrum See Acquisition Completion.
The acquisition of Spectrum Dynamics by Biosensors International Group, Ltd., is complete. Biosensors has acquired substantially all assets of Spectrum Dynamics, a leader in advanced functional assessment technologies, including those used to evaluate patients for cardiac interventions.
Class I Recall For Cook’s Zilver Peripheral Stent
The FDA has issued a Class I recall for the Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent. All sizes, diameters and lot numbers manufactured prior to April 16 2013 are implicated.
Significant And Sustained Blood Pressure Reduction With Vessix™ Renal Denervation System
Another one of the renal denervation big boys sees data presented which confirms sustainable blood pressure reduction. This time its Boston Scientific, seeing clinical results using its recently acquired Vessix balloon-based system.
CE Mark For Boston Scientific’s GUIDE™ DBS System
Boston Scientific Corporation has gained CE Mark approval for use of the GUIDE™ DBS System, the world’s first deep brain … continue reading “CE Mark For Boston Scientific’s GUIDE™ DBS System”
CoreValve® First TAVI To Get Valve-In-Valve CE Mark
Medtronic, Inc. has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut™ transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves.
Symplicity™ HTN-3 Renal Denervation Study Enrollment Complete
Medtronic, Inc. has announced it has finished randomizing Symplicity HTN-3, the company’s pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension. The company is hoping this is a landmark in its progress towards U.S. approval.
OrthoSensor™ Intelligent Knee Instruments Obviously Adding Value As Stryker Extends Agreement
OrthoSensor’s VERASENSE™ Intelligent Instrument System is obviously complementing Stryker’s Triathlon® Knee System as the two companies agree to extend their co-marketing arrangement.
St.Jude Medical Kicks Off EnligHTNment Study At EuroPCR
St. Jude Medical, Inc. has taken the opportunity presented by EuroPCR in Paris this week, to announce the start of … continue reading “St.Jude Medical Kicks Off EnligHTNment Study At EuroPCR”
CE Mark For World’s Longest Coronary Drug Eluting Stent
The newly CE marked XIENCE Xpedition™ 48 coronary stent leverages the well established design and clinical outcomes of the XIENCE Family of Drug Eluting Stents. A longer stent, compared with multiple short stents has the potential to reduce overall procedural costs, particularly in very long lesions most often seen in patients with diabetes.
FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters
The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. … continue reading “FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters”
FDA Clears Covidien’s Nellcor™ Pulse Oximetry Motion Claims
Covidien’s Nellcor™ pulse oximetry systems have received U.S. FDA 510(k) clearance for so-called “motion” claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio.