CE Mark for New Medtronic Drug-Eluting Stent
The Resolute Onyx™, a new drug-eluting stent from Medtronic has received approval from the Conformité Européene and, according to the company, is now available in countries that recognize the CE Mark. This new stent builds on the success of the Resolute Integrity; what makes the Onyx different is that the wire itself consists of a dense inner core, wrapped in a cobalt alloy outer layer. Dubbed CoreWire Technology, this enhancement makes the stent more radiopaque (easier to see under fluoroscopy), and stronger, even though the struts are thinner. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 3, 2014 Category: Cardiology Source Type: news
Opsens Files To Become a New Player in the Fractional Flow Reserve Market
Moving from the macro to the micro: that's the pathway taken by Quebec-based Opsens, Inc., known for its fiber optic pressure and temperature sensing technology in the oil fields. The company has miniaturized its technology and applied it to FFR wires that can be threaded into the coronary arteries to help determine whether or not a blockage needs to be opened with a stent. The company has filed with the FDA for 510(k) pre-market notification, recently achieved approval in Japan and is currently sponsoring the O2 Pilot Study. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 21, 2014 Category: Cardiology Source Type: news
Boston Scientific Begins Study of Drug-Eluting Stents in Women and Minorities
oday Boston Scientific enrolled its first patient in a new trial, dubbed PLATINUM Diversity trial, which will enroll up to 1,500 patients from these under-represented populations, specifically: Female, Black of African Heritage, Hispanic/Latino, American Indian or Alaska native. The trial will measure the performance of its drug-eluting stent, the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, in these groups. The principal investigators for the PLATINUM Diversity trial are Roxana Mehran, MD of Mount Sinai School of Medicine n New York, and Wayne Batchelor, MD of Tallahassee Memorial Hospital...
Source: News from Angioplasty.Org - October 20, 2014 Category: Cardiology Source Type: news
Medtronic Announces FDA Approval of Pacing Lead for Full-Body MRI Scans
Medtronic today announced the U.S. Food and Drug Administration (FDA) approval of its CapSureFix Novus™ MRI SureScan® 5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-conditional pacemaker. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 16, 2014 Category: Cardiology Source Type: news
Positive 30-Day Results in Medtronic's CoreValve Direct Aortic Study
Today Medtronic (NYSE: MDT) announced the 30-day results from its CoreValve ADVANCE Direct Aortic (DA) Study at the 29th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS 2014) in Milan. The results were "exceptional," showing low rates of all-cause mortality, stroke (0% disabling stroke), and paravalvular leak. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 13, 2014 Category: Cardiology Source Type: news
FDA Approves Lutonix 035: First Drug-Coated Balloon for Blockages in Leg Arteries
The U.S. FDA has approved the first drug-coated balloon for use in opening up blockages in the peripheral arteries, specifically the superficial femoral or popliteal arteries in the leg. The Lutonix 035 was approved in Europe in 2012 but has taken an additional two years for the FDA to give it the go-ahead. An FDA panel unanimously recommended approval back in June, although there were questions regarding the results that showed no additional benefit in women above the therapy of a standard non-coated balloon. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 13, 2014 Category: Cardiology Source Type: news
ACIST Showcases Hi-Definition IVUS System
At last month's Transcatheter Cardiovascular Therapeutics meeting in Washington, DC, a new high-definition intravascular ultrasound (IVUS) system was demonstrated as part of two live case broadcasts. The system, manufactured by ACIST Medical of Eden Prairie, Minnesota, is billed as "hi-def" because it images at a frequency of 60mHz. Current systems image in the range of 20mHz and 45mHz. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 8, 2014 Category: Cardiology Source Type: news
Lisa Olson Takes the Reins at the Society for Cardiovascular Angiography and Interventions (SCAI)
Next week, Lisa Olson will be heading up administration at the Society for Cardiovascular Angiography and Interventions (SCAI) in Washington, DC. Her naming as the new Executive Director of the main professional organization that represents interventional cardiologists in the U.S. was announced last month. She succeeds longtime administrator Norm Linsky. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 6, 2014 Category: Cardiology Source Type: news
SCAI Updates Its Appropriate Use Criteria (AUC) Calculator Apps for Stent Procedures
The Society for Cardiovascular Angiography and Interventions (SCAI) has announced an expansion and update to its Appropriate Use Criteria calculator apps, now incorporating data for diagnostic catheterization and imaging. SCAI introduced this tool two years ago to aid interventional cardiologists in their decision-making process and to help document those decisions in the patient's record. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 6, 2014 Category: Cardiology Source Type: news
Infraredx Gains Approval in Japan for Its NIR/IVUS Coronary Imaging System
Infraredx has announced that they have received approval in Japan for their TVC Imaging System, the only FDA-approved device to visualize and identify the large lipid core plaques that are thought to be most likely to cause a heart attack. Japan makes up 50% of the worldwide intravascular imaging market. The company, which has partnered with the Japanese firm Nipro, sees this approval as a significant milestone in their expansion strategy. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 1, 2014 Category: Cardiology Source Type: news
Glenn vs. The Volcano
Today saw a "volley across the bow" between Volcano Corporation (Nasdaq: VOLC), a major manufacturer of IVUS, FFR and iFR technologies, and Engaged Capital LLC, an investment firm which holds over two million shares, or 5.1%, of Volcano stock. Engaged founder Glenn W. Welling sent a letter to Volcano demanding that the company begin a search for a new CEO and find a buyer for the company. Volcano immediately issued a statement in response. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 29, 2014 Category: Cardiology Source Type: news
FDA OKs Medtronic's Euphora Non-Compliant Coronary Balloon Catheter
Coming just four months after its CE Mark European approval, the NC Euphora balloon has received the okay from the FDA for marketing in the United States. Non-compliant (NC) balloons are specifically designed to be used in post-stent dilatation, to ensure that the stent itself is fully expanded against the arterial wall. An under-expanded stent is associated with higher restenosis rates, as well as stent thrombosis, a phenomenon first described by Dr. Antonio Colombo in the early days of stenting. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 12, 2014 Category: Cardiology Source Type: news
Boston Scientific Announces Schedule For Presentations At Upcoming TCT 2014
Beginning Saturday, Boston Scientific Corporation (NYSE: BSX) will present data that reinforce the company's commitment to advancing science for life and to developing innovative therapies in interventional cardiology. The company will share results from more than a dozen clinical studies at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation, being held this year in Washington, D.C. from September 13-17. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 12, 2014 Category: Cardiology Source Type: news
Volcano Announces Activities at TCT 2014
The annual Transcatheter Cardiovascular Therapeutics meeting (TCT) starts this weekend in Washington, DC and runs through Wednesday, September 17. During that time many hundreds of presentations on the entire range of interventional procedures and devices will be offered to the 10,000 plus attendees. While the main focus usually has been on devices such as drug-eluting stents, balloons, and transcatheter aortic valve replacements (TAVR), an area that has become increasingly important in recent years is that of functional measurement. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 12, 2014 Category: Cardiology Source Type: news
Medtronic Begins U.S. Clinical Trial of Recapturable Transcatheter Aortic Valve
Last week Medtronic, Inc. (NYSE: MDT) garnered the European CE Mark for its newest transcatheter aortic valve. Today the first U.S. patients received Medtronic's CoreValve Evolut R, launching a U.S. trial of 250 patients at 25 centers. This trial will look at safety and effectiveness of this device in patients at high or extreme risk for open-heart surgery. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - September 11, 2014 Category: Cardiology Source Type: news
