Medtronic Goes Radial
Medtronic is now offering a full portfolio of transradial tools: a line of catheters, a TRA access kit with introducer sheath, and its TRAcelet ™ compression device for simplifying patent hemostasis post-procedure. Although the company previously has marketed a select number of items designed for the transradial approach (TRA), today's announcement marks the first full-transradial offering by a major stent manufacturer in the U.S. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 14, 2017 Category: Cardiology Source Type: news
First Drug-Coated Balloon (DCB) Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Studies
The IN.PACT SFA Japan Trial enrolled 100 patients at 11 sites in Japan who were randomized to treatment with either the DCB (n=68) or plain balloon angioplasty (percutaneous transluminal angioplasty, or PTA) (n=32). Per protocol, primary patency rates were assessed at 12 months of follow-up and demonstrated: 89.2 percent for the DCB group and 48.4 percent for the PTA group (p (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 9, 2017 Category: Cardiology Source Type: news
Medtronic CardioInsight Mapping Solution Cleared by FDA
Cardiac mapping - typically accomplished by inserting a catheter into the heart via an artery or vein - allows physicians to locate the origin of a patient's irregular heart rhythms (arrhythmias). In contrast, the CardioInsight system is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 8, 2017 Category: Cardiology Source Type: news
Medtronic Announces CE Mark for New Lower Profile HawkOne 6F Directional Atherectomy System
Medtronic plc (NYSE: MDT) today announced CE (Conformit é Européene) Mark approval for the HawkOne™ directional atherectomy system in a lower profile size for treating patients with peripheral artery disease (PAD). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 24, 2017 Category: Cardiology Source Type: news
Medtronic Announces CE Mark and European Launch of Recaptureable TAVI System Now Available for Severe Aortic Stenosis Patients with Large Anatomies
The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 20-25 percent of the eligible European TAVI patient population. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 17, 2017 Category: Cardiology Source Type: news
Abbott's Acquisition of St. Jude to Close This Week
As of Wednesday, January 4, St. Jude Medical will no longer exist as a company; instead it will become part of Abbott, according to the press release below. This $25 billion deal is one of the largest recent mergers of medical device companies since Medtronic's 2015 acquisition of Covidien. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 3, 2017 Category: Cardiology Source Type: news
Japan Announces Regulatory Process and Post Marketing Surveillance Policy for Abbott's Bioabsorbable Vascular Scaffolding
This article was provided to Angioplasty.Org by its Japanese partner, TCROSS NEWS) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 5, 2016 Category: Cardiology Source Type: news
Medtronic Announces Reimbursement Approval and Launch of CoreValve ™ Evolut™ R System in Japan
Medtronic plc (NYSE: MDT) today announced it has received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the recapturable, self-expanding transcatheter CoreValve ™ Evolut™ R System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with transcatheter aortic valve implantation (TAVI) is determined to be the best option. This approval follows the Shonin approval from the MHLW the company received in November.U (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 1, 2016 Category: Cardiology Source Type: news
Interview with Hiroki Shiomi, MD, PhD
This study randomized 700 patients to either routine angiographic follow-up post-PCI or to clinical follow-up only to see if there was any additional benefit to angiography which is practiced in 80% of patients in Japan. (Posted in collaboration with TCROSS NEWS.) (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 4, 2016 Category: Cardiology Source Type: news
Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large Anatomies
Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve ™ Evolut™ R 34mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 25-30 percent of the eligible global TAVR patient population. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 26, 2016 Category: Cardiology Source Type: news
Medtronic's IN.PACT Drug-Coated Balloon: First to Gain FDA OK for Treatment of In-Stent Restenosis in the Peripheral Vessels
The FDA has approved the first drug-coated balloon in the United States for the treatment of in-stent restenosis (ISR) in the peripheral arteries: Medtronic's IN.PACT Admiral drug-coated balloon (DCB). One-year outcomes from the IN.PACT Global ISR Imaging Cohort were presented at last year's VIVA meeting: the primary patency rate was 88.7% the clinically-driven target revascularization (CD-TLR) rate was 7.3%, outcomes that begin to approach what has been seen in the coronaries. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 14, 2016 Category: Cardiology Source Type: news
Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy
Medtronic plc (NYSE:MDT) today announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study. The study showed that the Medtronic-exclusive device-based EffectivCRT ™ during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF). The results were presented at the 2016 European Society of Cardiology (ESC) Congress in Rome. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 3, 2016 Category: Cardiology Source Type: news
New Long-Term Data Reinforce Safety Benefits of the World's Smallest Pacemaker
In the largest and longest clinical evaluation of leadless pacing patients to date, Medtronic plc (NYSE: MDT) today announced new long-term results from the Medtronic Micra ® Transcatheter Pacing System (TPS) Global Clinical Trial in a clinical trial update late-breaking session at the 2016 European Society of Cardiology (ESC) Congress in Rome. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 3, 2016 Category: Cardiology Source Type: news
SAPIEN3 Transcatheter Aortic Valve Gets FDA Approval for Patients at Intermediate Risk for Surgery
Edwards has received an important expansion of indications for its Transcatheter Aortic Valve (TAVR), the SAPIEN3. Initially approved only for patients at high risk for open surgery, the FDA has now approved use of the SAPIEN3 for patients at "intermediate risk" for surgery, specifically those who, according to the FDA announcement "are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality> 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS...
Source: News from Angioplasty.Org - August 22, 2016 Category: Cardiology Source Type: news
Can Drug-Coated Balloon plus Atherectomy Be a Successful Treatment for Calcified FemPop PAD?
Medtronic and VIVA Physicians have launched the REALITY study: to see if directional atherectomy, combined with a drug-coated balloon, is a successful therapeutic option for these difficult cases of calcified and symptomatic femoropopliteal peripheral artery disease (PAD). The study will enroll around 150 patients, who will be treated with Medtronic's HawkOne or TurboHawk atherectomy devices, and then the IN.PACT Admiral paclitaxel drug-coated balloon. Patients will be followed for two years. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - August 5, 2016 Category: Cardiology Source Type: news
