Device Companies
FDA Blames Poor Training for New Deaths, Injuries Tied to Stryker's Recalled Neptune Systems
March 19, 2013 2:30 pm | by Mass Device | News | CommentsThe FDA this month issued updated warnings to clinics still using Stryker's (NYSE:SYK) recalled Neptune 1 Silver or Neptune 2 Ultra surgical waste management systems, noting that there have been additional deaths and patient injuries since Stryker initiated the recall last year.
The Medtronic Foundation Launches Its "Save a Life" Campaign with the Timberwolves' Ricky Rubio
March 15, 2013 1:26 pm | by Mass Device | News | CommentsRising Timberwolves basketball star Ricky Rubio is the face of the Medtronic (NYSE:MDT) Foundation's new televised public service announcement, " The Heart Rescue Project." This new campaign for sudden cardiac arrest (SCA), the leading cause of death among young athletes, debuted online last month.
Stryker Announces the Launch of the ES2 Spinal System
March 15, 2013 9:01 am | by PR Newswire | News | CommentsALLENDALE, N.J., March 15, 2013 /PRNewswire/ -- Stryker announced today the launch of the ES2 Spinal System. The ES2 system is built on Stryker's trusted Xia 3 pedicle screw technology, which has been used in approximately 500,000 cases worldwide. ES2's streamlined implant and...
J&J Faces Second Trial in Recalled Hip Controversy
March 14, 2013 8:29 am | by Mass Device | News | CommentsHealthcare giant Johnson & Johnson denied claims this month in the second of tens of thousands of patient injury lawsuits over its implanted metal-on-metal hips. The company countered complaints brought by Carol Strum, who claimed that her ASR hip implant failed due to a defect in design and that she required revision surgery after just three years.
VertiFlex®, Inc. Announces Sale of Certain Non-Core Spinal Implant Technologies to Stryker
March 13, 2013 12:46 pm | by The Associated Press | News | CommentsSAN CLEMENTE, Calif.--(BUSINESS WIRE)--Mar 13, 2013--VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies , today announced the sale of certain assets to Stryker Corporation’s Spine Division relating to spinal implants that are not core to the ongoing...
Johnson & Johnson Announces Opening of London Innovation Centre
March 12, 2013 8:00 pm | by The Associated Press | News | CommentsJohnson & Johnson today announced the opening of the Johnson & Johnson Innovation centre in London, one of four regional hubs being established this year in the world's leading innovation hotspots. A part of Johnson & Johnson Innovation, the goal of the London innovation centre is...
Stryker Gets FDA Warning Letter After Inspection
March 12, 2013 3:39 pm | by The Associated Press | News | CommentsOrthopedic maker Stryker Corp. said Tuesday that it received a warning from government regulators about quality control issues and unapproved marketing of medical devices. The company said it got the letter from the Food and Drug Administration following a November inspection of its Portage, Mich., facility.
J&J's Cordis Snaps Up Flexible Stenting Solutions
March 12, 2013 2:41 pm | by Mass Device | News | CommentsCordis Corp., the stent-making arm of healthcare colossus Johnson & Johnson, said it's acquired Flexible Stenting Solutions as part of turning its back on the coronary stents market in favor of the endovascular arena. Bridgewater, N.J.-based Cordis didn't reveal the purchase price or any details for its buyout of FSS, which makes the FlexStent self-expanding stent.
St. Jude Medical launches Ilumien Optis in Japan
March 12, 2013 10:03 am | by Mass Device | News | CommentsSt. Jude Medical (NYSE:STJ) said its launched the Ilumien Optis device in Japan, calling it the only medical device on the market to combine fractional flow reserve and optical coherence tomography technology to allow doctors to evaluate the state and severity of coronary lesions.
FDA Warns Stryker on Quality Systems, Recalls, and Neptune Marketing
March 12, 2013 9:38 am | by Mass Device | News | CommentsStryker said that the FDA sent it a warning letter stemming from an November 2012 inspection of a plant in Portage, MI. The company said the letter, based on "quality system observations," flagged it for failing to tell the agency of a product recall and for marketing devices including its Neptune waste management system without 510(k) clearance from the FDA.
FDA Gives Siemens the Green Light for Angiography Device
March 11, 2013 6:00 pm | by Mass Device | News | CommentsTechnology giant Siemens won FDA clearance to begin distributing the Artis Q and Artis Q.zen angiography systems in the U.S. The technology includes a new X-ray tube with lower radiation levels and updated software for more precise imaging, according to Siemens.
GE, NFL & Leading Healthcare Experts Team up to Accelerate Concussion Research, Diagnosis & Treatment
March 11, 2013 1:00 pm | by The Associated Press | News | CommentsNEW YORK--(BUSINESS WIRE)--Mar 11, 2013--(NYSE: GE) – GE and the NFL today announced the Head Health Initiative, a four-year, $60 million collaboration to speed diagnosis and improve treatment for mild traumatic brain injury. The goal of the research and innovation program, guided by healthcare...
With Medtronic Resolute Stent, Interrupting Dual Antiplatelet Therapy After One Month Showed No Increased Safety Risk in Robust Analysis
March 11, 2013 12:18 pm | by The Associated Press | News | CommentsCardiologists at ACC.13 learned today that patients with coronary artery disease who received a Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) as participants in one of several clinical studies and interrupted or discontinued their dual antiplatelet therapy after one month of the implant procedure showed no increased safety risk through one year of follow-up.
St. Jude Medical Announces Launch of 3D Vessel Reconstruction Technology in Japan
March 11, 2013 8:00 am | by The Associated Press | News | CommentsST. PAUL, Minn.--(BUSINESS WIRE)--Mar 11, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of its ILUMIEN ™ OPTIS ™ System, a next-generation technology designed to help physicians make personalized stenting decisions based on each patient’s...
New Data Reinforce Significant Blood Pressure Reduction Sustained to Two Years Using the Symplicity(TM) Renal Denervation System
March 10, 2013 12:18 pm | by The Associated Press | News | CommentsMedtronic, Inc. announced 24-month data from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation. Presented for the first time today at the 62nd Annual Scientific Session of the American College of Cardiology, the data show patients treated with the Symplicity renal denervation system (n=66) sustained a significant drop in blood pressure.
The Boston Scientific PROMUS Element™ Platinum Chromium Stent Demonstrates Continued Low Event Rates Through Three Years
March 10, 2013 11:30 am | by PR Newswire | News | CommentsNATICK, Mass., March 10, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reported clinical endpoint data from the PLATINUM workhorse clinical trial comparing the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Coronary...
Abbott's Minimally Invasive MitraClip® System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery
March 10, 2013 11:30 am | by PR Newswire | News | CommentsSAN FRANCISCO, March 10, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip® System for the treatment of mitral...
Boston Scientific Apologizes for Embargo Breach that Got Its Watchman Trial Pulled from Conference
March 9, 2013 11:16 pm | by Mass Device | News | CommentsAmerican College of Cardiology conference organizers cancel the highly anticipated presentation of preliminary results from Boston Scientific's PREVAIL study after the company leaks the data ahead of time. Boston Scientific publishes the slides that would have been presented.
The Boston Scientific Watchman@ Device Continues To Demonstrate Positive Clinical Outcomes For Patients With Atrial Fibrillation
March 9, 2013 2:24 pm | by The Associated Press | News | CommentsBoston Scientific Corporation (NYSE: BSX) reports preliminary data in the PREVAIL clinical trial met two out of three co-primary endpoints. The PREVAIL trial evaluates safety and efficacy of the WATCHMAN@ Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial...
Boston Scientific's Watchman Heart Implant Shows Improved Safety Profile in Preliminary Results
March 9, 2013 12:12 pm | by Mass Device | News | CommentsBoston Scientific hopes to reassure FDA regulators about the safety and efficacy of its Watchman stroke prevention implant with results from its PREVAIL study, the presentation for which was pulled from the lineup at the American College of Cardiology conference in San Francisco today.
ACC13: Boston Scientific's PREVAIL clinical trial presentation canceled
March 9, 2013 11:54 am | by Mass Device | News | CommentsMedical device giant Boston Scientific (NYSE:BSX) will not present its highly anticipated PREVAIL clinical trial results at the American College of Cardiology conference as planned this morning after the presentation was canceled when the company leaked the data ahead of time.
Jury Deems J&J's Depuy ASR XL Hip Implant Defective in Design, Orders $8.3M in Damages
March 8, 2013 2:20 pm | by Mass Device | News | CommentsA California jury ruled against Johnson & Johnson and its DePuy subsidiary in finding that the company's ASR XL metal-on-metal hip implant was defectively designed. The decision marks the highly anticipated close of the 1st of more than 10,750 such lawsuits against J&J.
Report: Boston Scientific Issues Alert on Its Lead-Free S-ICD Defibrillator
March 8, 2013 1:43 pm | by Mass Device | News | CommentsBoston Scientific recently issued a warning on its lead-free implantable defibrillators over concerns that a fuse malfunction could prevent the devices from delivering life-savings shocks. The company has received reports of four instances in which a fuse inside the subcutaneous ICD was activated inappropriately.
St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation
March 8, 2013 8:00 am | by The Associated Press | News | CommentsST. PAUL, Minn.--(BUSINESS WIRE)--Mar 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first patient implant in a new pivotal trial evaluating the company’s AMPLATZER ™ Cardiac Plug (ACP) for the prevention of stroke. The AMPLATZER ™ Cardiac Plug...
Medtronic Submits IDE to FDA for U.S. Randomized Clinical Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure Between 140-160 mm Hg
March 7, 2013 10:19 am | by The Associated Press | News | CommentsMedtronic, announced today that the company has submitted an Investigational Device Exemption to the U.S. FDA to study the Symplicity renal denervation system for the treatment of uncontrolled hypertension in patients with systolic blood pressure between 140-160 mm Hg despite treatment with three or more anti-hypertensive medications of different classes.
