Getinge wins expanded FDA clearance for Sterizone VP4
Getinge (PINK:GETI B) said today it won expanded FDA clearance for its Sterizone VP4 sterilizer, now cleared to sterilize colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to 4 channels and 3.5 meters in length.
The Swedish medical device firm touted the win, saying that regulatory authorities are becoming more scrutinous of medical device reprocessing, particularly for colonoscopes and other complex minimally invasive surgical devices.
“With the new FDA-cleared indications for use, the Sterizone VP4 Sterilizer is the only validated and cleared low-temperature sterilizer available in the ...
Source: Mass Device - July 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration Getinge Source Type: news
GORE(R) VIABAHN(R) Endoprosthesis Found to Provide Superior Patency and Reduced Interventions Versus Balloon Angioplasty Alone for Challenging AV Access Cases
New data from Gore REVISE Clinical Study published online in Journal of Vascular Surgery illustrate role device can play in maintaining and salvaging failing dialysis circuits
FLAGSTAFF, Ariz.--(Healthcare Sales & Marketing Network)--W. L. Gore & Associ... Devices, InterventionalW. L. Gore, VIABAHN, Endoprosthesis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 28, 2016 Category: Pharmaceuticals Source Type: news
Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months.
The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA alone for treating challenging AV access cases, both in terms of primary patency and number of interventions during the study period.
Results from the study were published in the Journal of Vascular Surgery, Newark, Del.-based Gore said.
“Pa...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular W.L. Gore & Associates Source Type: news
Intact Vascular launches clinical trial of Tack system
Intact Vascular said today it launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s (NYSE:MDT) Admiral drug-coated angioplasty balloon for treating peripheral arterial disease.
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 Tack endovascular system is the ideal adjunct to drug-coated balloon angioplas...
Source: Mass Device - June 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Intact Vascular Source Type: news
OrbusNeich expands into PAD
OrbusNeich said today it expanded its portfolio to include its Jade and Scoreflex percutaneous transluminal angioplastyballoon devices designed to treat peripheral artery disease.
The balloon devices are OrbusNeich’s 1st foray into lower limb and arteriovenous fistula intervention, the Hong Kong-based company said.
“Broadening our offering to include peripheral products is a natural progression for OrbusNeich. We have a strong reputation in designing balloons for treating highly complex coronary lesions and now we bring this technology to our dedicated peripheral devices to help physicians treat the difficult p...
Source: Mass Device - May 24, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular OrbusNeich Source Type: news
iVascular wins CE Mark for Luminor 18 DCB
Spanish vascular device company iVascular S.L.U. said today it won CE Mark approval in the European Union for its Luminor 18 drug eluting balloon designed for lower limb angioplasty.
The Luminor 18 is 0.018 guidewire compatible and has an extra low profile, and joins the company’s Luminor 14 and Luminor 35 portfolio of drug-eluting balloons
“The CE mark approval of Luminor 18 represents a key milestone for iVascular S.L.U. Our extensive range of products will contribute to providing better support and service to patients and physicians,” CEO Lluis Duocastella said in a press release.
The Barcelona, Spain-...
Source: Mass Device - May 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance iVascular S.L.U. Source Type: news
Cath Lab Recap: PAD Balloon Angioplasty; 'Hybrid' PCI
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 13, 2016 Category: Cardiology Source Type: news
Medtronic touts multi-trial In.Pact Admiral data
Medtronic (NYSE:MDT) today released a bevy of new data from clinical studies of its In.Pact Admiral drug coated balloon designed for treating peripheral artery disease.
The Fridley, Minn.-based released data from 3 different studies of its In.Pact Admiral DCB at the 2016 Charing Cross Symposium meeting in London, including 1-year results from a chronic total occlusion imaging cohort and 2-year gender and diabetic subgroup analysis.
“The In.Pact Admiral drug-coated balloon’s unique coating delivers paclitaxel in a solid state which results in durable tissue levels of drug leading to prolonged anti-restenotic e...
Source: Mass Device - April 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Medtronic Source Type: news
Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S.
This article originally appeared on MassDevice.com’s sister site, Medical Design & Outsourcing.
The post Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S. appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Nipro Source Type: news
Nipro Medical Corporation launches the Cronus(TM) HP 0.035" OTW PTA Balloon Catheter in the United States
BRIDGEWATER, N.J., Feb. 19, 2016 -- (Healthcare Sales & Marketing Network) -- Nipro North America, a division of Nipro Medical Corporation, announced the launch of the Cronus HP high-pressure, 0.035" over-the-wire (OTW) percutaneous transluminal angi... Devices, Interventional, Product LaunchNipro Medical, Cronus HP, balloon catheter, angioplasty (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 19, 2016 Category: Pharmaceuticals Source Type: news
New Real-World Comparison Showing Similar Efficacy Between the Lutonix ® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.” (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 10, 2016 Category: Cardiology Source Type: news
New Real-World Comparison Showing Similar Efficacy Between the Lutonix® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.” (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 10, 2016 Category: Cardiology Source Type: news
MassDevice.com +3 | The top 3 medtech stories for February 4, 2016
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. Toshiba bails on non-imaging healthcare biz
Toshiba said today that it’s planning to ditch or transfer all of its healthcare business that’s not a part of Toshiba Medical Systems, its imaging division, and forecast higher losses for the rest of the year.
A bidding war for Toshiba M...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Maquet & Biotronik ink distribution deal for peripheral devices
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Medical Systems USA said today it is partnering with Biotronik to distribute the German firms peripheral vascular devices in the U.S.
Maquet will distribute “a range” of Biotronik products designed to treat peripheral artery disease, including its Astron iliac self-expanding stent, Passeo percutaneous transluminal angioplasty balloon products and the line of Fortress reinforced sheaths, the companies said.
“Peripheral artery disease is a serious condition that can lead to amputations. Because the global prevalence of this disease is increasing, the need ...
Source: Mass Device - February 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Distribution Biotronik Getinge Maquet Cardiovascular LLC Source Type: news
Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 81
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 599
Total Active: 423
Total On Hold: 176
Summary of All PMA Submissions
Originals: 3
Supplements: 92
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 81
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 163.1
FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
