Log in to search using one of your social media accounts:

 

Avinger slashes jobs, Q3 sales down 61%
Avinger (Nasdaq:AVGR) – maker of the Lumivascular image-guided, catheter-based system to treat peripheral artery disease (PAD) – continued to experience declining sales as it retrenched during the third quarter, according to its newest earnings report. The Redwood, Calif.–based company has been cutting jobs and other costs– and focusing on existing accounts and winning FDA clearance for new devices. Avinger had 73 employees, including 20 sales employees, as of Oct. 15. The number is down nearly two-thirds from the 197 employees, including 70 in sales, that the company had at the end of 201...
Source: Mass Device - November 13, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiovascular Catheters Imaging News Well Avinger Source Type: news

New Analyses Presented At AHA 2017 Show Repatha ® (evolocumab) Significantly Reduced Cardiovascular Events In Patients With Peripheral Artery Disease And In Patients With A History Of Heart Attacks
Data Support Use of Repatha to Reduce Risk of Recurrent Cardiovascular Events in Patients With History of Multiple Heart Attacks Additional Analysis Found That Patients With More Recent Heart Attacks Experienced Substantial Risk Reductions With Repatha Repatha Benefit in Peripheral Artery Disease Patients Presented at AHA Scientific Sessions 2017 and Simultaneously Published in "Circulation" THOUSAND OAKS, Calif., Nov. 13, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced five new subgroup analyses from the Repatha® (evolocumab) cardiovascular outcomes study (FOURIER) that s...
Source: Amgen News Release - November 13, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

PCSK9 Inhibitor improves outcomes for patients with peripheral artery disease
(Brigham and Women's Hospital) A new sub-analysis of the FOURIER clinical trial, however, now offers information on the safety and effectiveness of giving the PCSK9 inhibitor evolocumab on top of statin therapy to patients with peripheral artery disease. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 13, 2017 Category: International Medicine & Public Health Source Type: news

PCSK9 Inhibitor Improves Outcomes for Patients with Peripheral Artery Disease
LDL-cholesterol-lowering drug evolocumab reduced risk of major cardiovascular events and major adverse limb events among peripheral artery disease sub-population from the FOURIER trial. (Source: BWH News)
Source: BWH News - November 13, 2017 Category: Hospital Management Source Type: news

PCSK9 Inhibitor Improves Outcomes for Patients with Peripheral Artery Disease
LDL-cholesterol-lowering drug evolocumab reduced risk of major cardiovascular events and major adverse limb events among peripheral artery disease sub-population from the FOURIER trial. (Source: BWH for Journalists)
Source: BWH for Journalists - November 13, 2017 Category: Research Source Type: news

Amgen Announces New Analyses Of High-Risk Patient Subgroups From Repatha ® (evolocumab) Cardiovascular Outcomes Study At AHA Scientific Sessions 2017
Late-Breaking Repatha Presentations Assess Impact on Peripheral Artery Disease and Heart Attack Patients THOUSAND OAKS, Calif., Nov. 6, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new analyses will be presented from the Repatha® (evolocumab) cardiovascular outcomes study, including analyses investigating the efficacy of Repatha in high-risk patients with peripheral artery disease (PAD) and those who have experienced a prior heart attack. In total, five distinct analyses from the Repatha cardiovascular outcomes study (FOURIER), including two accepted for late-breaker scientific sessions, wil...
Source: Amgen News Release - November 6, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency (for specialized target groups only)
The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack / The application for marketing approval is based on the COMPASS study / If approved, the rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin low dose once daily, will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient population (Source: Bayer Company News)
Source: Bayer Company News - November 6, 2017 Category: Pharmaceuticals Source Type: news

Stem cells from muscle could address diabetes-related circulation problems
(University of Illinois at Urbana-Champaign) Stem cells taken from muscle tissue could promote better blood flow in patients with diabetes who develop peripheral artery disease, a painful complication that can require surgery or lead to amputation. A new study in mice at the University of Illinois found that an injection of the stem cells prompted new blood vessels to grow, improving circulation in the affected tissues and function in the affected limbs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 6, 2017 Category: International Medicine & Public Health Source Type: news

What Causes White Nails?
Discussion The nail matrix covers the area of the nail plate, and extends proximally in a crescent moon shape with the edges of the crescent extending proximally and inferiorly toward the underlying bone. The nail matrix is a multilayered epithelium that physiologically produces keratinization and gives rise to the nail plate. The distal matrix forms the lower 2/3s of the nail plate and the proximal matrix forms the upper 1/3 of the nail plate. the thickness of the nail plate is proportion to the matrix’s thickness. The nail plate’s free edge contour follows the shape of the nail’s lunula. Melanocytes occ...
Source: PediatricEducation.org - November 6, 2017 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Surmodics goes head-to-head with Medtronic ’ s drug-coated balloon in pivotal trial
Surmodics (NSDQ:SRDX) announced today that the first patient was enrolled in a pivotal clinical trial evaluating its SurVeil drug-coated balloon. The 446-patient trial is designed to compare the company’s SurVeil device to Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon as a treatment for peripheral artery disease in the upper leg. Get the full story at our sister site, Drug Delivery Business News. The post Surmodics goes head-to-head with Medtronic’s drug-coated balloon in pivotal trial appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular Wall Street Beat Medtronic SurModics Inc. Source Type: news

Avinger wins CE Mark for in-stent restenosis indication for image-guided atherectomy
Avinger (NSDQ:AVGR) said today that it won CE Mark approval for treating in-stent resenosis with its Pantheris Lumivascular atherectomy system. The company’s Lumivascular tech enables physicians to see from inside the artery during a directional atherectomy procedure in real-time, Avinger touted, using optical coherence tomography. The device is designed to help physicians more accurately navigate their devices to treat peripheral artery disease. “The demand for improved treatment options for in-stent restenosis is growing as physicians experience the accurate visualization and precision provided by state-...
Source: Mass Device - September 28, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Imaging Regulatory/Compliance Vascular Wall Street Beat Avinger Source Type: news

Shockwave Medical touts Disrupt BTK lithoplasty system study results
Shockwave Medical today released results from the Disrupt below the knee study of its Shockwave Lithoplasty system designed to treat peripheral artery disease, touting low rates of residual stenosis and low vascular complications. Data from the study was presented at the annual Cardiovascular and Interventional Radiological Society of Europe congress in Copenhagen, Denmark. “Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous Disrupt PAD Study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium i...
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Shockwave Medical Source Type: news

SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath
SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months. The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction and particulates, the Eden Prairie, Minn.-based company said. SurModics said the clearance and coming launch of the low-profile PTA cath is a continuation of the company’s strategy to supply whole-product vascular solutions. ...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular SurModics Inc. Source Type: news

PQ Bypass touts subset analysis data from Detour system trial
PQ Bypass today released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days. The data was presented today at the Vascular InterVentional Advances conference, the Sunnyvale, Calif.-based company said. Results came from a 6-month subset analysis of 50 patients who underwent percutaneous treatment of femoropopliteal blockages with lengths between 25 cm and 45 cm, the company said. PQ Bypass said it was sucessfully able to treat the blockages w...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular PQ Bypass Source Type: news

'Phenomenal' pill slashes heart disease deaths by 22%
The clinical trial, which was conducted on 27,000 coronary or peripheral artery disease patients from 33 countries, has since been halted - 12 months early - because of the exciting results. (Source: the Mail online | Health)
Source: the Mail online | Health - September 11, 2017 Category: Consumer Health News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 8, 2017
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. Resilience Capital Partners creates Innovatus Imaging Private equity firm Resilience Capital Partners recently announced that one of its funds has acquired three medical device service and manufacturing units, allowing the firm...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Japan approves Medtronic ’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The In.Pact Admiral DCB has demonstrated superior one-year clinical outcomes in Japan and across Medtronic In.Pact SFA clinical trials, providing patients with an improved restoration of blood flow and reduced need for additional revasc...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Medtronic Source Type: news

Cardiovascular disease warning - charity said this could explain RISE in hospital cases
CARDIOVASCULAR disease - an umbrella term for diseases including coronary heart disease, angina, heart attack, heart rhythm problems, inherited heart disease, aneurysms, peripheral vascular disease and stroke. (Source: Daily Express - Health)
Source: Daily Express - Health - September 7, 2017 Category: Consumer Health News Source Type: news

Understanding the causes and risks of peripheral artery disease (Video)
Pain and discomfort in the legs or calf muscles can be a sign of arterial blockage and identifies patients at increased potential risk for heart attack or stroke. A condition called atherosclerosis occurs when plaque builds up inside of a person ’s arteries, and it is the main cause of peripheral artery disease (PAD). Early diagnosis of PAD and treatment may help prevent heart attack or stroke. What is peripheral artery disease? PAD is caused by atherosclerosis, cholesterol deposits in the… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 31, 2017 Category: Biotechnology Authors: Dr. Luke Marone Source Type: news

Understanding the causes and risks of peripheral artery disease (Video)
Pain and discomfort in the legs or calf muscles can be a sign of arterial blockage and identifies patients at increased potential risk for heart attack or stroke. A condition called atherosclerosis occurs when plaque builds up inside of a person ’s arteries, and it is the main cause of peripheral artery disease (PAD). Early diagnosis of PAD and treatment may help prevent heart attack or stroke. What is peripheral artery disease? PAD is caused by atherosclerosis, cholesterol deposits in the… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 31, 2017 Category: American Health Authors: Dr. Luke Marone Source Type: news

Statin Therapy Reduces Amputation Risk in Diabetes and PAD Statin Therapy Reduces Amputation Risk in Diabetes and PAD
Statin use may help protect against the risk of lower-extremity amputation among patients with type 2 diabetes and peripheral artery disease.Journal of Clinical Endocrinology & Metabolism (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 30, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

Medicare will cover treadmill therapy for patients in 2018
Starting next year, Medicare will cover treadmill therapy for patients who have peripheral artery disease (PAD), which causes people to have debilitating leg pain. (Source: the Mail online | Health)
Source: the Mail online | Health - August 29, 2017 Category: Consumer Health News Source Type: news

Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events by 24%, including a 42% reduction in strokes and a 22% reduction in cardiovascular death, the company reported. Get the full story at our sister site, Drug Delivery Business News. The post Xarelto, aspirin combo reduces risk of cardiovascular event...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Pharmaceuticals Wall Street Beat Bayer Janssen Pharmaceuticals johnsonandjohnson Source Type: news

Screening for vascular disease saves one life for every 169 patients assessed (VIVA)
(European Society of Cardiology) A novel screening program for vascular disease saves one life for every 169 men assessed, according to late-breaking results from the VIVA trial presented today in a Hot Line LBCT Session at ESC Congress and published in the Lancet. The combined screening for abdominal aortic aneurysm, peripheral artery disease, and hypertension gained more living years for lower costs than European cancer screening programs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 28, 2017 Category: International Medicine & Public Health Source Type: news

XARELTO ® (rivaroxaban) Significantly Reduced Major Cardiovascular Events in Patients with Stable Coronary and Peripheral Artery Disease in Pivotal Phase 3 Study
(Source: Johnson and Johnson)
Source: Johnson and Johnson - August 27, 2017 Category: Pharmaceuticals Source Type: news

Bayer ’s Xarelto® significantly lowered the combined risk of stroke, cardiovascular death and heart attack in patients with chronic coronary or peripheral artery disease by 24% (for specialized target groups only)
Importantly, rivaroxaban vascular dose, 2.5 mg twice daily, plus aspirin 100 mg once daily showed an unprecedented 42% relative risk reduction in stroke and 22% in cardiovascular death compared with aspirin 100 mg once daily alone / Bleeding rates were low, and while major bleeding was increased, notably there was no significant increase in intracranial or fatal bleeding / This combination regimen demonstrated a substantial improvement in net clinical benefit of 20% (Source: Bayer Company News)
Source: Bayer Company News - August 27, 2017 Category: Pharmaceuticals Source Type: news

Researchers find combination therapy works best for heart diseases
(McMaster University) A major international study has found that the combination of two drugs -- rivaroxaban and aspirin -- is superior to aspirin alone in preventing further heart complications in people with vascular disease.The study of 27,400 people with stable coronary or peripheral artery disease from 33 countries worldwide shows that the combination of 2.5 mg of rivaroxaban twice daily plus 100 mg of aspirin once daily was significantly better than only aspirin or only rivaroxaban in preventing heart attacks, strokes and death. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 27, 2017 Category: International Medicine & Public Health Source Type: news

Getinge launches Biotronik ’ s Pulsar-18 SES in the US
Getinge (PINK:GETI B) said today it launched Biotronik‘s Pulsar-18 self-expanding stent in the US, operating as Biotronik’s distributor in the region for its portfolio of peripheral artery disease devices. Biotronik claims that the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with a 4-French delivery system, which it said makes the device and associated procedures simple and more efficient. “As more patients are diagnosed with PAD due to our aging population, interventional and surgical teams need access to innovative, proven p...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Stents Biotronik Getinge Source Type: news

Getinge announces full U.S. availability of Pulsar(R)-18 self-expanding stent from BIOTRONIK for patients with peripheral artery disease
Getinge expands partnership with BIOTRONIK as part of its commitment to provide healthcare providers with innovative solutions that help improve patient outcomes. WAYNE, N.J., Aug. 22, 2017 -- (Healthcare Sales & Marketing Network) -- Getinge, a leadin... Devices, Interventional, Product Launch Getinge, BIOTRONIK, Pulsar-18, stent , peripheral artery disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 22, 2017 Category: Pharmaceuticals Source Type: news

VentureMed raises $15m in Series B
Vascular focused device developer VentureMed said today it raised $15 million in a Series B round. The round was led by newly invested Endeavour Vision and joined by RiverVest Venture Partners, the Toledo, Ohio-based company said. “Endeavour Vision’s current fund is dedicated to transformational technologies in medical devices and digital health. We are excited to support a company with the potential to make significant improvements in the lives of millions of men and women globally who suffer from peripheral vascular diseases and others suffering from the challenging management of renal dialysis access,”...
Source: Mass Device - August 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News venturemed Source Type: news

Peripheral artery disease more common in people with HIV with lower CD4 counts
Peripheral artery disease, one of the most common forms of cardiovascular disease, occurs more frequently in people with HIV who have CD4 cell counts below 500, regardless of whether they smoke or have other risk factors for cardiovascular disease (Source: PHPartners.org)
Source: PHPartners.org - August 15, 2017 Category: International Medicine & Public Health Source Type: news

VentureMed Group Raises $15 Million Series B Equity Financing
Endeavour Vision and RiverVest Venture Partners Lead Funding TOLEDO, Ohio, Aug. 15, 2017 -- (Healthcare Sales & Marketing Network) -- VentureMed Group®, Inc., ("VMG" or the "Company") a medical device company developing and comm... Devices, Interventional, Venture Capital VentureMed Group, FLEX Scoring Catheter, peripheral artery disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 15, 2017 Category: Pharmaceuticals Source Type: news

Cardiovascular Systems touts 1-year, sub-analysis data from Liberty PVI study
Cardiovascular Systems (NSDQ:CSII) today released both 1-year and a sub-analysis results from the Liberty 360 clinical trial of peripheral interventions, including those using its DiamondBack 360 coronary orbital atherectomy system. The 1,200 patient study aimed to evaluate acute and long-term clinical outcomes of peripheral interventions for patients with peripheral artery disease, with the most common device used being the company’s Diamondback 360, the St. Paul, Minn.-based company said. 1-year outcomes were presented at the 2017 Amputation Prevention Symposium in Chicago by Dr. Jihad Mustapha of Michiga...
Source: Mass Device - August 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Cardiovascular Systems Inc. Source Type: news

Philips closes $2B Spectranetics acquisition
Royal Philips (NYSE:PHG) said yesterday it closed its $2.2 billion deal to acquire US vascular intervention device maker Spectranetics (NSDQ:SPNC). With the closure, Spectranetics and its financial results will be consolidated into Philips image-guided therapy business, the company said. Philips said that Spectranetics employs over 900 individuals and is currently posting double-digit growth, with projected 2017 sales of approximately $300 million. The $38.50-per-share deal valued Spectranetics at $2.16 billion (€1.9 billion), including cash and debt, and is a 27% premium on SPNC’s $30.40 closing ...
Source: Mass Device - August 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions royalphilips Spectranetics Corp. Source Type: news

VM BioPharma begins dosing in Phase III trial of VM202 for NHU and PAD
Korean biopharmaceutical company ViroMed ’s US division VM BioPharma has begun dosing patients with VM202 in a Phase III clinical trial to treat non-healing diabetic foot ulcers (NHU) and associated peripheral artery disease (PAD). (Source: Drug Development Technology)
Source: Drug Development Technology - August 3, 2017 Category: Pharmaceuticals Source Type: news

Cardiovascular Systems shares down despite Q4, FY2017 earnings beat
Shares in Cardiovascular Systems (NSDQ:CSII) fell today despite the medical device maker beating expectations on Wall Street with its 4th quarter and fiscal year 2017 earnings and announcing that the recall of its saline infusion pumps, initiated in April, is nearing completion. The St. Paul, Minn.-based company posted profits of $772,000, or 2¢ per share, on sales of $52.9 million for the 3 months ended June 30, seeing a 115.8% swing from losses while sales grew 9.2% compared with the same period last year. Earnings per share for the quarter beat out the 5¢ loss-per-share consensus on Wall Street, where ana...
Source: Mass Device - August 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Cardiovascular Systems Inc. Source Type: news

VM BioPharma Announces First Patient Dosed in Phase 3 Study of Gene Therapy Candidate VM202 for Non-Healing Diabetic Foot Ulcers
First Pivotal Gene Therapy Trial to Target Underlying Peripheral Artery Disease in Non-Healing Diabetic Foot Ulcers ATLANTA, Aug. 3, 2017 -- (Healthcare Sales & Marketing Network) -- VM BioPharma, the United States division of ViroMed Co., Ltd. in Seou... Biopharmaceuticals, Wound Care VM BioPharma, VM202, diabetic foot ulcer, peripheral artery disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 3, 2017 Category: Pharmaceuticals Source Type: news

Is your leg pain too painful?
There ’s pain you can walk off, but some leg pain — you just can’t ignore. Pain experienced in the legs while you’re out for a walk could be a symptom of a common circulatory condition, often hard to diagnose. When plaque builds up in any of the blood vessels outside of the heart (arteries, veins , or lymphatic vessels), the result is peripheral vascular disease (PVD). PVD can slowly and steadily restrict circulation and is dangerous when left untreated. Plaque buildup in a leg artery is… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 1, 2017 Category: American Health Authors: Dr. Siddharth Patel Source Type: news

Is your leg pain too painful?
There ’s pain you can walk off, but some leg pain — you just can’t ignore. Pain experienced in the legs while you’re out for a walk could be a symptom of a common circulatory condition, often hard to diagnose. When plaque builds up in any of the blood vessels outside of the heart (arteries, veins , or lymphatic vessels), the result is peripheral vascular disease (PVD). PVD can slowly and steadily restrict circulation and is dangerous when left untreated. Plaque buildup in a leg artery is… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 1, 2017 Category: Biotechnology Authors: Dr. Siddharth Patel Source Type: news

Surmodics to launch pivotal trial for drug-coated balloon
Surmodics (NSDQ:SRDX) said today that it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon. The trial is slated to compare the Eden Prairie, Minn.-based company’s device with Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon for patients with peripheral artery disease in the upper leg. Get the full story at our sister site, Drug Delivery Business News. The post Surmodics to launch pivotal trial for drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 26, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Vascular Wall Street Beat Medtronic SurModics Inc. Source Type: news

Biotronik wins FDA nod for atrial lead-less Intica ICD line
Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US. The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity in the atrium, as the system itself provides the necessary atrial signal information. Atrial diagnostics are used for the early detection of supraventricular tachycardia, atrial fibrillation and atrial ventricular synchronization. “When treating heart failure p...
Source: Mass Device - July 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news

Less invasive treatment for blocked artery in the leg is safe, review finds
This study shows that the orbital atherectomy treatment can offer patients a safe and effective alternative to surgery.AUTHORSThe authors of the study are Dr. Michael Lee and Dr. Daniel Heikali of UCLA; Dr. Jihad Mustapha of Metro Health Hospital in Wyoming, Mich.; Dr. George Adams of Rex Healthcare in Raleigh, N.C.; and Dr. Ehtisham Mahmud of UC San Diego.JOURNALThis  study was published  by the peer-reviewed journal Vascular Medicine.FUNDINGThis research was funded Cardiovascular Systems Inc., the makers of the orbital atherectomy device.DISCLOSURES​Drs. Lee, Mustapha and Adams received funding from Cardiovas...
Source: UCLA Newsroom: Health Sciences - July 19, 2017 Category: Universities & Medical Training Source Type: news

Philips picks up peripheral thrombectomy device maker CardioProlific
Royal Philips (NYSE:PHG) last week said it paid an unspecified amount to acquire stealthy CardioProlific and the peripheral thrombectomy catheters it’s developing. Philips said the deal for Hayward, Calif.-based CardioProlific is complementary to its $2.16 billion acquisition of Spectranetics (NSDQ:SPNC) and its own line of image-guided therapies. “The acquisition of CardioProlific will further strengthen our innovation pipeline of catheter-based therapy devices,” image-guided therapy business leader Bert van Meurs said in prepared remarks. “We are convinced that the development of CardioP...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Mergers & Acquisitions cardioprolific peripheral royalphilips Source Type: news

Heartburn drugs linked to premature death
Conclusion This larger set of observational data finds that PPI drugs are associated with an increase in the risk of early death compared with either H2 blockers or no acid suppression drugs. This was the case for participants both with and without gastrointestinal problems. It also appears as though the longer the PPIs drugs are taken, the greater the risk of death. Considering that these drugs are widely used in the UK, these findings may cause concern. But the research has a number of important limitations: The study was conducted in a population of mostly white, older US male veterans, which might limit the abi...
Source: NHS News Feed - July 4, 2017 Category: Consumer Health News Tags: Medication Source Type: news

Biotronik touts Pulsar-18 self expanding stent trial data
Biotronik today released results from the Bioflex-I pivotal clinical trial of its Pulsar-18 self-expanding stent designed for treating patients with peripheral artery disease, touting high rates of freedom from major adverse events and primary patency. The company claims the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with a 4-French delivery system , which it claims makes the device and associated procedures simple and more efficient. “More than 8.5 million people in the United States have peripheral artery disease. This patient pop...
Source: Mass Device - July 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Biotronik Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 23, 2017
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. Bard wins FDA approval for LifeStream covered iliac stent C.R. Bard said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treat...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Bard wins FDA approval for LifeStream covered iliac stent
C.R. Bard (NYSE:BCR) said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said. “C. R. Bard is proud to build upon its vast history and experience in angioplasty balloons, stents and covered stents to offer physicians this new option,” chairman & CEO Timothy Ring said in prepared remarks. “The LifeStream covered stent expands t...
Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stents Wall Street Beat C.R. Bard Peripheral Artery Disease Source Type: news

India regulator wants price caps on more coronary, peripheral devices
Indian healthcare regulators reportedly reversed course and are now asking for a quartet of medical devices to be added to a list of products under price control. India’s National Pharmaceutical Pricing Authority wants its list of price-capped products updated to include balloon and cardiac catheters, covered stents and peripheral stents, Reuters reported. If the government there approves, they would join bare-metal, drug-eluting and bioresorbable stents, which were added to the NPPA’s “essential medicines” list in February. That move cut their price by as much as 75%. After the caps ...
Source: Mass Device - June 7, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat Abbott Boston Scientific Indian National Pharmaceutical Pricing Authority (NPPA) Medtronic Peripheral Artery Disease Source Type: news