VIVA 2015 Roundup: Medtronic touts Valiant stent graft, PAD stent-treatment data
Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev.
The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valian Captivia thoracic stent graft system for treating type B aortic dissections, reporting safety and efficacy at 2-years.
Data from the 2-year follow up of the 35-patient FDA approved IDE trial reported no post-index procedure ruptures or conversions, device related adverse events or loss of ...
Source: Mass Device - November 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Abbott Avinger Boston Scientific C.R. Bard Cook Medical Medtronic Spectranetics Corp. TriVascular TVA Medical Vascular Dynamics Vascular Interventional Advances (VIVA) Source Type: news
Medtronic touts In.Pact Admiral DCB data
Medtronic (NYSE:MDT) today touted data from a pair of studies of its In.Pact Admiral drug-coated balloon, presented today at the annual Vascular Interventional Advances conference in Las Vegas.
Researchers revealed the formal cost-effectiveness analysis of the U.S. cohort of Medtronic’s In.Pact SFA trial, and in-stent restenosis cohort data from its In.Pact Global study.
Medtronic said the 2-year, prospective cost-effectiveness study of 181 patients showed that, although treatment with the drug-coated balloon was more expensive than with standard percutaneous transluminal angioplasty, costs were actually $100 lowe...
Source: Mass Device - November 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Drug-Eluting Balloons Medtronic Peripheral Artery Disease Vascular Interventional Advances (VIVA) Source Type: news
AV Medical wins FDA 510(k) for Chameleon balloon catheter
Israel based AV Medical said today it won FDA 510(k) clearance for its Chameleon angioplasty balloon catheter.
The company’s Chameleon catheter comes equipped with proximal injection port technology which the company claims make it the 1st and only angioplasty balloon catheter that allows for simultaneous balloon inflation and injection of intravascular fluids during guidewire access.
“Our entire team is thrilled with this news. Chameleon represents the first product to include our proprietary Proximal Injection Port design. We look forward to bringing Chameleon to the dialysis access market in the United State...
Source: Mass Device - October 26, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Vascular AV Medical Source Type: news
Medtronic Touts Drug-Coated Balloon Clinical Data
Medtronic plc has announced that new two-year clinical data from the pivotal IN.PACT SFA Trial revealed that the IN.PACTAdmiraldrug-coated balloon (DCB) continues to provide superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries or SFA) and behind the knee (popliteal arteries). (Source: Medical Design Online News)
Source: Medical Design Online News - October 15, 2015 Category: Medical Equipment Source Type: news
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, while the primary safety endpoint was a composite of freedom from device- and procedure-related death after 30 days and freedom from target limb major amputation and clinically-d...
Source: Mass Device - October 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Drug-Eluting Balloons Medtronic TCT 2015 Source Type: news
Tryton Medical touts side branch stent study data
Tryton Medical said yesterday that data from a post hoc analysis of a randomized clinical trial of its Tryton side branch stent for patients with coronary bifurcation lesions showed reductions in target vessel failure and improved side branch diameter.
Results from the study were published in the journal Catheterization and Cardiovascular Interventions.
The 289-patient post-hoc analysis focused on patients with side branch bifurcation lesions 2.25 mm in diameter or greater.
The study reported that target vessel failure was lower in the Tryton-treated group compared to the control, and that patients treated with the compan...
Source: Mass Device - October 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Stents Tryton Medical Inc. Source Type: news
PAD: Intact Vascular wins IDE for Tack endo repair
Intact Vascular said today it won FDA Investigative Device Exemption for a clinical trial of its Tack endovascular system for patients with peripheral arterial disease undergoing percutaneous angioplasty.
The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, Wayne, Penn.-based Intact Vascular said.
“The earlier Toba experience demonstrates that the long term results from angioplasty can be substantially improved if we repair arterial dis...
Source: Mass Device - September 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Food & Drug Administration (FDA) Vascular Intact Vascular Peripheral Artery Disease Source Type: news
Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 80
Summary of PMA Originals Under Review
Total Under Review: 53
Total Active: 22
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 575
Total Active: 418
Total On Hold: 157
Summary of All PMA Submissions
Originals: 4
Supplements: 72
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 80
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 115.2
FDA Time: 97.1 ...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
MassDevice.com +3 | The top 3 medtech stories for August 3, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. CR Bard’s Lutonix wins Medicare reimbursement add-on
C.R. Bard said that angioplasty treatments with its Lutonix drug-coated balloon will now be eligible for add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payme...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
CR Bard’s Lutonix wins Medicare reimbursement add-on
C.R. Bard (NYSE:BCR) said today that angioplasty treatments with its Lutonix drug-coated balloon will now be eligible for add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems.
The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients with the Lutonix during inpatient settings and is slated to go into effect October 1, C.R. Bard said.
“After providing reimbursement in the outpatient setting earlier this year, CMS has now provided additional reimbursement for the Lutonix DCB in the inpati...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Food & Drug Administration (FDA) Medicare Vascular C.R. Bard Centers for Medicare and Medicaid Services (CMS) Source Type: news
Bard, Medtronic win Medicare reimbursement add-on for DCBs
Medtronic (NYSE:MDT) and C.R. Bard (NYSE:BCR) said today that angioplasty treatments with drug-coated balloons will now be eligible for new technology add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems.
The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients for peripheral artery disease with Bard’s Lutonix and Medtronic’s In.Pact Admiral drug-coated balloon during inpatient settings. The new coverage is slated to go into effect October 1.
“Medtronic has been lead...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Food & Drug Administration (FDA) Medicare Vascular C.R. Bard Centers for Medicare and Medicaid Services (CMS) Source Type: news
Case series: anxiety and agitation following exposure to the synthetic cannabinoid ADB-PINACA
3 out of 5 stars
A Common Source Outbreak of Severe Delirium Associated with Exposure to the Novel Synthetic Cannabinoid ADB-PINACA. Schwartz MD et al. J Emerg Med 2015 May;48:573-80.
Abstract
As noted in a recent survey of synthetic cannabinoid exposures in the New England Journal of Medicine, the synthetic cannabinoid (SC) ADB-PINACA was associated with outbreaks in August and September 2013, both in Brunswick GA (22 cases) and Denver CO (> 220 exposures).
This paper reports on 7 cases from the outbreak in Georgia. All patients tested positive for ADB-PINACA or its metabolic ADB-PINACA-5-Pentoic Acid in plasma a...
Source: The Poison Review - July 29, 2015 Category: Toxicology Authors: Leon Tags: Medical ADB-PINACA agitation anxiety black mamba case series crazy clown delirium synthetic cannabinoid Source Type: news
Another stent better than DEB, DCB for in-stent restenosis, studies find
Treatment with another stent, rather than from a drug-coated or drug-eluting balloon, has been shown to be more effective in treating coronary in-stent restenosis, according to 2 new studies.
The 2 studies, 1 European and 1 Japanese, were published in the Journal of the American College of Cardiology earlier this month.
The 309-patient European Ribs IV clinical trial looked at patients with drug-eluting stent in-stent restenosis, comparing the efficacy of retreatment with drug-eluting balloons and everolimus-eluting stents. Results from the study indicated that patients treated with EES showed an 8% lower rate of cardiac d...
Source: Mass Device - July 15, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Drug-Eluting Stents Journal of the American College of Cardiology Source Type: news
Bard touts publication of Lutonix study in NEJM
C.R. Bard (NYSE:BCR) said last Thursday that a 2-year study of its Lutonix drug-coated balloon catheter was published in The New England Journal of Medicine.
The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said.
“We want to thank the investigators involved in the Levant 2 trial for their authorship of this ground-breaking study. Publication of the study results in The New England Journal of Medicine demonstrates the high quality of the trial ...
Source: Mass Device - June 29, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular C.R. Bard New England Journal of Medicine Source Type: news
Bard's Drug-Coated Angioplasty Balloon Continues to Show Efficacy
(Source: MDDI)
Source: MDDI - June 25, 2015 Category: Medical Equipment Authors: Arundhati Parmar Tags: Implantable Devices Source Type: news
