HeartMate mechanical circulatory support device implantation will benefit from Thoratec’s acquisition of transapical access specialist Apica Cardiovascular.
Cardio
HeartMate III™ CE Mark Trial Starts with First Human Implant
Thoratec Corporation has started its CE Mark Clinical Trial for HeartMate III™ and has seen a first patient implanted with the new device.
PixArt Introduces Wearable Heart Rate Monitor
Human-machine interface specialist PixArt Imaging Inc., has announced the release of its Heart Rate Monitor sensor for smart phones and wearable device platforms.
MGuard™Prime EPS Back on EU Market After Mods
Inspire MD has modified its MGuard Prime Embolic Protection Stent in order to address dislodgement issues. The EU authorities have given them the nod to return it to the market.
TAVI Pendulum Swings Back Edwards Way as Sapien XT Gets FDA Approval
After its main competitor gained approval last week, now Edwards has its own reason to celebrate as the next generation Sapien XT gets the FDA’s nod.
Tomorrow Your Company’s Ours: Medtronic Swallows Covidien
With a combined revenue of $27 Billion, the acquisition of Covidien by Medtronic makes for one helluva company that promises to have fingers in every conceivable medtech pie.
Strong Clinicals Behind FDA Approval of CoreValve® for High-risk Patients
Strong clinical results from Medtronic’s pivotal CoreValve High Risk study have persuaded the FDA to extend its approval to include patients at high risk for conventional surgery.
HeartWare Sanguine on FDA Warning Letter Resolution
HeartWare International tells us it will respond to the FDA over its warning letter, and has resolution of the matters raised well in hand.
Chocolate Catheter Gets Coronary Indication
TriReme’s Chocolate Catheter gets Coronary indication
STENTYS Acquires New Self-Apposing Stent Delivery Capability
STENTYS is to acquire the assets of Cappella Peel Away Inc to enhance delivery of its next Self-Apposing Stent
Data Review Supports ICD Use in LVEF 30-35 Patients
According to a new study, ICDs have for the first time been found to be associated with improved survival among heart failure patients whose left ventricles only pump 30 to 35 percent of blood out of the heart with each contraction.
Economic Arguments Back Up Orbital Atherectomy Clinical Data, Says Manufacturer
Cardiovascular Systems, Inc. points us at one-year data and a new economic analysis from its ORBIT II coronary study in a late-breaker session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2014 conference last week.
St. Jude and CardioMEMS Seal the Deal
St. Jude Medical, Inc. has completed its acquisition of CardioMEMS, Inc., developer of the CardioMEMS™ HF System. The acquisition was completed on May 30, 2014.
Boston Scientific Touts Positive 6 Month Data from Lotus™ TAVI Study
New data presented at EuroPCR 2014 in Paris suggests impressive performance at six months for the Lotus™ Valve System, with 79.8 percent of patients showing no paravalvular aortic regurgitation at six months with no cases of severe paravalvular aortic regurgitation in any patient.
Long-term Data Supports OrbusNeich Combo™, “First and Only” Dual Therapy Stent
OrbusNeich’s novel COMBO™ Dual Therapy Stent has been shown in a three year study to actively promote rapid endothelialization and deliver long-term, true vessel healing with no thrombotic events reported.
Direct Flow of Good News Stories
Direct Flow Medical tells us about positive 12 month outcomes from the DISCOVER CE Mark Trial. Results were featured at this week’s EuroPCR in an oral presentation by principal investigator Joaquim Schofer, MD, from the Medical Care Center, Hamburg, Germany.