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TCT 2015

TCT 2015: One-year results bear out for Edwards Lifesciences’ Sapien 3 valve, Sapien XT wins FDA PMA

October 15, 2015 By Brad Perriello

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 […]

Filed Under: Clinical Trials, Replacement Heart Valves Tagged With: Edwards Lifesciences, TCT 2015

TCT 2015: Two-year results from Medtronic’s In.Pact SFA trial

October 14, 2015 By Brad Perriello

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, […]

Filed Under: Cardiovascular Tagged With: Drug-Eluting Balloons, Medtronic, TCT 2015

TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump

October 14, 2015 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Catheters, Clinical Trials Tagged With: Elixir Medical Corp., Micell Technologies Inc., Stentys, stjudemedical, TCT 2015, Tryton Medical Inc.

TCT 2015: HeartFlow’s CT-based FFR lowers costs, improves quality of life

October 14, 2015 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Clinical Trials, Imaging Tagged With: HeartFlow, TCT 2015

TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies

October 13, 2015 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Clinical Trials Tagged With: Medtronic, TCT 2015

TCT 2015: Medtronic touts CoreValve TAVI real-world registry data

October 13, 2015 By Fink Densford

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. […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Clinical Trials Tagged With: Medtronic, TCT 2015

TCT 2015: More 2-year data on Bard’s Lutonix DEB

October 13, 2015 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Clinical Trials Tagged With: C.R. Bard, Drug-Eluting Balloons, Peripheral, TCT 2015

TCT 2015: Early data on Medtronic’s drug-filled stent

October 12, 2015 By Brad Perriello

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 […]

Filed Under: Clinical Trials, Stents Tagged With: Medtronic, TCT 2015

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