Updated: Added new FDA approval information on the Sapien XT The low rate of complications seen with the next-generation Sapien 3 replacement heart valve made by Edwards Lifesciences (NYSE:EW) at 30 days persisted for a full year, researchers said today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco. The company also announced its Sapien XT Transcatheter […]
TCT 2015: Two-year results from Medtronic’s In.Pact SFA trial
Two-year results from Medtronic‘s (NYSE:MDT) In.Pact SFA study showed that the drug-eluting balloon was better than conventional balloon angioplasty, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. The 331-patient study randomized subjects 2:1 to either treatment with Medtronic’s In.Pact Admiral DEB or standard angioplasty. The primary efficacy endpoint was primary patency, […]
TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer. The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects […]
TCT 2015: HeartFlow’s CT-based FFR lowers costs, improves quality of life
A non-invasive test of cardiac function made by HeartFlow lowered the cost of care and delivered improved quality of life scores compared to standard care, according to a study presented yesterday at the annual Transcatheter Cardiovascular Therapeutics conference. HeartFlow’s FFRCT test uses data from a standard CT scan to create a 3D map of the changes in blood flow […]
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco. Early thrombectomy’s promise Totaled? The 10,064-patient Total study compared PCI alone and PCI with […]
TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device. The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. […]
TCT 2015: More 2-year data on Bard’s Lutonix DEB
C.R. Bard (NYSE:BCR) yesterday released 2-year results from a small group of patients in a real-world registry study of its Lutonix drug-eluting balloon at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco. Bard said the Lutonix 035 device, which is designed to treat peripheral artery disease, showed a 94.3% rate of freedom from target lesion revascularization in […]
TCT 2015: Early data on Medtronic’s drug-filled stent
Early data from a small set of patients implanted with Medtronic‘s (NYSE:MDT) drug-filled stent, presented today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco, showed that the device “achieved rapid and well-controlled stent coverage,” the company said today. The DFS is built using the Fridley, Minn.-based medical device giant’s Resolute Integrity and Resolute Onyx stents, using […]
