Intuitive Surgical, Inc. has announced that it received FDA clearance to market its EndoWrist® One™ Vessel Sealer instrument for use with the da Vinci® Si™ Surgical System.
Vascular
Bard’s Lutonix Acquisition Fuels Race For First FDA Approved Drug-Coated PTA Balloon
C. R. Bard, Inc’s acquisition of Lutonix, Inc will position it well to be the first company to gain FDA clearance for a drug coated PTA balloon in what is estimated could be a $1Bn market.
Cook Medical Makes Irish Eyes Smile
Cook Medical, is to invest up to €16.5m over four years creating highly skilled positions in Research and Development activities at its Limerick site, with Government support through IDA Ireland.
Fibrocaps™ Haemostat Study Shows Promising Reduction In Time To Haemostasis
Dutch Haemostasis and Regenerative Medicine company ProFibrix B.V., has announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to haemostasis and incidence of haemostasis at 3, 5 and 10 minutes, as compared to active control.
FDA Likes “Chocolate”… PTA Balloon Catheter
TriReme Medical, Inc.has received 510(K) FDA approval to market its “Chocolate” PTA balloon catheter for the treatment of occluded peripheral arteries in the United States.
Steris and Toshiba To Collaborate On Hybrid Surgical Suites.
STERIS Corporation and Toshiba America Medical Systems, Inc.have formed an alliance to offer advanced vascular, cardiovascular, pediatric and neurosurgical hybrid surgical suites.
FDA Wants Shrinkage Warning on Boston Scientific’s Newly Approved Promus Element™ Stent
Boston Scientific’s Promus Element Drug Eluting Stent was approved by FDA in late November and now the agency has demanded that the company includes a warning on its packaging about the risk of stent shrinkage.
Angio-Seal Disputes: Kensey Nash And St. Jude Medical Agree To Mediation
Kensey Nash Corporation and St. Jude Medical will enter into non-binding mediation in an attempt to resolve disputes over royalty payments to Kensey Nash relating to the Angio-Seal vascular closure device, as well as other related claims.
90% Of Retrievable IVC Filters Not Retrieved According To Boston Researchers
Boston researchers have found that less than 10% of retrievable IVC filters were removed from patients, despite the fact that the indication for the filter placement was no longer present at discharge.
Two New Products From Boston Scientific
Boston Scientific launchea CHARGER™ PTA Balloon catheter in USA and Infinion 16, first and only 16-contact percutaneous lead for treatment of patients suffering chronic pain.
“Meerkats And Avatars” Cambridge (UK) Technology Event
Cambridge Technology Showcase: Reducing incidence of falls in the elderly, bringing cheap diagnosis of killer diseases, aid for physios with sophisticated gait analysis, coatings for medical devices to reduce biofilms.
Covidien Gets FDA Approval 6 Years After CE Mark
Covidien has announced that the U.S. Food and Drug Administration (FDA) has expanded the cope of approval for its SpiderFX® embolic protection device to include the treatment of severely calcified lesions used in conjunction with plaque excision in arteries of the lower extremities.
European Clot Management Device Market To Grow To $200 Million By 2016
Most Significant Growth In Clot Management Market Will Be in Mechanical Thrombectomy Procedures, According to Millennium Research Group.
Multidisciplinary European Endovascular Therapy Congress In Rome Next Month
The tenth running of the Multidisciplinary European Endovascular Therapy (MEET) congress will be held in Rome on December 1st-3rd, at the Crowne Plaza St Peters Hotel.
European Peripheral Vascular Market Will Grow To More Than $1 Billion By 2016
Device Innovations, Including Drug-Coated Balloons and Drug-Eluting Stents, Will Help Drive Growth, According to Millennium Research Group
CE Mark For NeoVasc Reducer™ Product To Treat Refractory Angina
Neovasc Inc. has announced that it has received the CE mark designation for its Reducer™ product for the treatment of refractory angina.