Medtronic touts low CD-TLR rates, strong durability in 3-year In.Pact Admiral DCB study | VIVA 2016 Roundup
Medtronic (NYSE:MDT) this week released data from 2 clinical studies evaluating its In.Pact Admiral drug-coated balloon for treating claudication and restenosis, touting sustained durability at 3-years. Results were presented at the Vascular Interventional Advances 2016 conference in Las Vegas this week. 3-year outcomes from the In.Pact SFA trial showed Medtronic’s balloon had long-term clinical benefit superior to plain balloon angioplasty, reported Dr. Prakash Krishnan of New York’s Mt. Sinai Heart. “The In.Pact Admiral is the only DCB to-date with superior performance...
Source: Mass Device - September 22, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Endoscopic / Arthroscopic C.R. Bard Medtronic Mercator MedSystems Shockwave Medical Source Type: news

FDA approves 6-month endpoint in trial of Bard ’ s Lutonix 014 drug-coated balloon
C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the knee. The Lutonix devices are designed to elute the anti-stenosis drug paclitaxel as the balloon is inflated to dilate narrowed arteries. The federal safety watchdog approved a 6-month safety...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Drug-Device Combinations C.R. Bard Peripheral Artery Disease 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

MassDevice.com +5 | The top 5 medtech stories for September 13, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Orthofix launches study of pulsed electromagnetic fields in treating osteoarthritis Orthofix said today it enrolled the 1st patient in a study exploring the use of its Physio-Stim pulsed electromagnetic field system for treatin...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA approves Medtronic ’ s In.Pact Admiral DCB for in-stent restenosis
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients. The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study comparing the DCB treatment with standard percutaneous balloon angioplasty. “Prior to the FDA approval of In.Pact Admiral DCB for ISR, physicians were challenged to find a durable treatment for PAD patients, consideri...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Medtronic Peripheral Artery Disease Source Type: news

Study: Drug-coated balloons beat plain balloon angioplasty in peripheral vessel disease
Drug-coated balloon treatments reduce the risk of target lesion revascularization in treating femoropopliteal artery disease by 67% when compared to plain balloon angioplasty procedures, according to a new study. Results from the study were published in the Journal of the American College of Cardiology: Cardiovascular Interventions. The study aimed to compared the risk of target lesion revascularization and all-cause death at 12 months with the 2 different treatments, with secondary objectives that included identifying factors that could have influenced general findings. A total of 8 trials which compared DCB and PB proced...
Source: Mass Device - August 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Journal of the American College of Cardiology Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 11, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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. Get this in your inbox everyday by subscribing to our newsletters.   5. GI Dynamics looks to next year for 2nd bite at FDA apple for EndoBarrier GI Dynamics is hoping to make another run at FDA approval for its flagship EndoBarrier treatment for obesity and diabetes after its 1st try failed last ye...
Source: Mass Device - August 11, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Spectranetics releases final 1-year results for Stellarex drug-coated balloon
Spectranetics (NSDQ:SPNC) today released the final 1-year results from the Illumenate EU RCT study comparing treatment with its Stellarex drug-coated balloon to percutaneous transluminal angioplasty, touting a 24% higher rate of primary patency with the DCB. One-year results from the 328-patient trial were presented at the Amputation Prevention Symposium in Chicago this week. “The Stellarex DCB produced outstanding results in this rigorous trial, validating its earlier first-in-human and interim Illumenate global studies. These consistent, high quality outcomes are achieved with a low dose drug balloon, making this d...
Source: Mass Device - August 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Spectranetics Corp. 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

Mercator MedSystems launches BTK micro-infusion trial
Mercator MedSystems said today it enrolled the 1st patient in the Limbo-ATx trial of the company’s Bullfrog micro-infusion device. The trial is slated to enroll 120 patients and aims to explore the benefit of localized drug delivery using the company’s device in maintaining vascular health when used alongside atherectomy procedures, the company said. “This is a very important step for Mercator. There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee. Our results from Micro-Infusion in above-knee arteries from our Dance-Pilot study and our most recent exp...
Source: Mass Device - July 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Drug Pumps Vascular Mercator MedSystems Source Type: news

Medtronic Receives FDA Approval for IN.PACT Admiral DCB 150 mm Lengths
Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT™ Admiral™ drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - July 13, 2016 Category: Cardiology Source Type: news

FDA approves longer version of Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that the FDA approved a longer version of its In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won CE Mark approval in the European Union. “The expansion of In.Pact Admiral DCB to 150mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment,” peripheral unit general manager&nbs...
Source: Mass Device - July 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Peripheral Artery Disease Source Type: news

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&n...
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 angio...
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-rest...
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 n...
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

Biotronik expands DCB line with CE Mark for Passeo-18 Lux
Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval for the device was based on the randomized, controlled Biolux P-I clinical trial, with results published in the Journal of Endovascular Therapy. “Effective treatment of infrapopliteal arterial disease is quite challenging as it involves high-risk patients...
Source: Mass Device - January 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Biotronik Source Type: news

Contego Medical Announces Positive Clinical Data for Paladin(R) System, the First Post-Dilation Balloon with Integrated Embolic Protection(TM) Technology
Data presented at the Leipzig Interventional Course (LINC) demonstrates breakthrough treatment for Carotid Artery Disease RALEIGH, N.C., Jan. 26, 2016 -- (Healthcare Sales & Marketing Network) -- Contego Medical, an innovator in developing next generat... Devices, InterventionalContego Medical, Paladin System, angioplasty balloon, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 26, 2016 Category: Pharmaceuticals Source Type: news

Mercator MedSystems launches dual-therapy BTK Bullfrog device trial
Mercator MedSystems said yesterday it enrolled the 1st patient in its Limbo-PTA clinical trial aiming to examine the use of the company’s Bullfrog micro-infusion device delivering anti-inflammatory steroids along with angioplasty to treat patients with below the knee critical limb ischemia. The Emeryville, Calif.-based company said that the purpose of adding an anti-inflammatory drug, delivered by its Bullfrog device, is to eliminate biological signals that cause scar tissue build up and can lead to restenosis. Mercator said this commonly occurs, and leads to re-obstruction in below-the-knee balloon angioplasty ...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Clinical Trials Drug-Device Combinations Vascular Mercator MedSystems Source Type: news

Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015: Summary of PMA Originals & Supplements Approved Originals: 3 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 30 Total On Hold: 27 Summary of PMA Supplements Under Review Total Under Review: 583 Total Active: 433 Total On Hold: 150 Summary of All PMA Submissions Originals: 4 Supplements: 75 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 69 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 193.4 FDA Tim...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

VasSol touts data on MRI-based blood flow measurement
VasSol said last week that results from a trial of its Nova non-invasive optimal vessel analysis showed that the device was able to identify critical trial patients at higher risk of recurrent stroke. The results from the study were published in the JAMA Neurology journal. Results from the 6-year, multi-center Veritas trial indicated that patients who experience a stroke in the back of their brain, and continue to have reduced blood flow to the area, have a higher risk of having another stroke within 2 years. “Nova is the only technology that can visualize and quantify the volume, speed and direction o...
Source: Mass Device - January 21, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials Diagnostics Software / IT VasSol Source Type: news

The Biggest Medical Stories You May Have Missed In 2015
SPECIAL FROM Next Avenue By Craig Bowron As we head into the New Year, let’s take a look back and see what lessons we should have learned from medical science in 2015. The New England Journal of Medicine’s publication Journal Watch provides physicians and other health care providers with expert analysis of the most recent medical research. Below is a brief synopsis of what the Journal Watch editors felt were the most important stories in general medicine for the year 2015. While you likely heard about a couple, others probably escaped your radar. Getting Aggressive with Strokes We’re familiar with the id...
Source: Science - The Huffington Post - January 15, 2016 Category: Science Source Type: news

Contego Medical Announces European Commercialization of the Paladin(R) Carotid Post-Dilation Balloon with Integrated Embolic Protection(TM) Technology
Presenting at the Leipzig Interventional Course (LINC) from January 26th-29th in Leipzig, Germany. RALEIGH, N.C., Jan. 14, 2016 -- (Healthcare Sales & Marketing Network) -- Contego Medical today announced the European commercialization of the Paladin&r... Devices, Interventional, Product LaunchContego Medical, Paladin System, angioplasty balloon, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 14, 2016 Category: Pharmaceuticals Source Type: news

Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease
Medtronic plc (NYSE:MDT) today announced that the IN.PACT® Admiral® drug eluting balloon has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 12, 2016 Category: Cardiology Source Type: news

Medtronic wins CE Mark for In.Pact Admiral DCB for end-stage renal disease
Medtronic (NYSE:MDT) said today its In.Pact admiral drug eluting balloon won CE Mark approval in the European Union for arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease. The device is now cleared for preventing restenosis in hemodialysis access sites by opening up the artery and delivering paclitaxel to the vessel wall. A 40 cm catheter shaft will also be made available alongside the expanded indication for the device. “For patients with hemodialysis, maintaining AV access is their lifeline to receiving the care they need to filter waste from their system. I...
Source: Mass Device - January 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Medtronic Source Type: news

Medtronic to Build New Plant in Ireland for Manufacturing the IN.PACT Drug-Coated Balloon
This week, Medtronic announced that it was investing $14 million to build a new 20,000 sq. ft. plant in Galway, Ireland, specifically to manufacture the IN.PACT drug-coated balloon. This project is a direct outgrowth of Medtronic's merger with Ireland-based Covidien, a company which had its own DCB, the Stellarex, which was sold off to Spectranetics as part of the requirements for the merger. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 17, 2015 Category: Cardiology Source Type: news

Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals & Supplements Approved Originals: 9 Supplements: 133 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: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Ti...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

FDA warns on intravascular device coating separation issues
The FDA said today that clinicians using intravascular medical devices such as catheters and guidewires should be aware of issues that can arise when their hydrophilic or hydrophobic lubricious coatings separate. The coatings reduce friction between the device and the blood vessel, but when the coating begins to flake, peel or slough off, the federal watchdog said patients could be at risk of serious injury. The agency warned of the issue in a safety communication, specifically mentioning intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems used during mini...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Vascular Source Type: news

How Your Genes Influence What Medicines Are Right for You
This article was originally published on The Conversation. Read the original article. -- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website. (Source: Healthy Living - The Huffington Post)
Source: Healthy Living - The Huffington Post - November 22, 2015 Category: Consumer Health News Source Type: news

SurModics picks up Creagh Medical for $32m
SurModics (NSDQ:SRDX) said today it acquired percutaneous transluminal angioplasty balloon catheter developer and manufacturer Creagh Medical for $32 million. The acquisition included an upfront payment of $19 million (€18 million) and a possible $12.8 million (€12 million) based on milestones and revenue achievements. Other terms of the deal were not disclosed. “We are excited about the acquisition of Creagh Medical and the strategic fit of its balloon catheter design and development, and manufacturing capabilities, which are critical to our transformation into a whole-product solutions provider. We are di...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Mergers & Acquisitions Creagh Medical SurModics Inc. Source Type: news

Spectranetics wins 510(k) clearance for laser atherectomy cath
Spectranetics (NSDQ:SPNC) said yesterday it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis. The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said. “Patients with ISR present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease. Turbo-Power, with its eccentric tip design, allows far more effective debulking of ISR lesions and I ...
Source: Mass Device - November 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Catheters Regulatory/Compliance Vascular Spectranetics Corp. Source Type: news

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&n...
Source: Mass Device - November 7, 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 actual...
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 clin...
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 co...
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: 9...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news