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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

Teleflex ’ s Vascular Solutions recalls Venture catheters
Teleflex (NYSE:TFX) subsidiary Vascular Solutions is recalling its Venture line of catheters after discovering a manufacturing defect that could cause embolisms. “After an internal investigation, VSI has concluded there is a potential for excess material used to manufacture the catheter to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient,” the company wrote in an April 25 letter to customers. Vascular solutions said there have been no report...
Source: Mass Device - June 7, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Catheters Recalls Peripheral Artery Disease Teleflex Vascular Solutions Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 2, 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. Endologix touts 30-day data from study of Ovation stent graft in women Endologix touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women. The Lucy trial showed that at least 28% more w...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Abbott whistleblower Colquitt loses appeal in off-label lawsuit
The whistleblower behind a decade-old lawsuit against Abbott (NYSE:ABT) lost his bid for a new trial after a federal appeals court this week denied his appeal. Former Guidant sales rep Kevin Colquitt sued Abbott, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) in 2006 for $219.4 million, claiming that they marketed the use of biliary stents to treat peripheral artery disease. (The magistrate overseeing the lawsuit, Judge Barbara Lynn of the U.S. District Court for Northern Texas, later let J&J and Boston Scientific off the hook.) Abbott acquired G...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Stents Abbott Guidant Corp. Whistleblower (qui tam) lawsuit Source Type: news

FDA clears Ra Medical ’ s Dabra areteriosclerosis laser
Medical excimer laser developer Ra Medical said it won FDA 510(k) clearance for its Dabra system designed to treat patients with peripheral artery disease. The Carlsbad, Calif.-based company said that the system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, touting the device and associated procedures as cost and time saving. “Dabra’s pivotal study demonstrated 95% success without any clinically significant adverse events. Furthermore, the Dabra Catheter is unique in its ability to cross Chronic Total Occlusions without having to cross the lesion wi...
Source: Mass Device - May 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Vascular Ra Medical Source Type: news

Beta-blockers 'useless' for many heart attack patients, study reports
Conclusion This study aimed to see whether beta blockers reduce mortality in people who've had a heart attack but who don't have heart failure or systolic dysfunction. It found no difference between those who were and those who were not given beta-blockers on discharge from hospital. The authors say this adds to the evidence that routine prescription of beta blockers might not be needed for patients without heart failure following a heart attack. Current UK guidelines recommend all people who have had a heart attack take beta blockers for at least one year to reduce risk of recurrent events. Only people with heart failure ...
Source: NHS News Feed - May 30, 2017 Category: Consumer Health News Tags: Heart/lungs Medication Source Type: news

For healthier arteries, eat more fruits and vegetables
(Reuters Health) - Eating more fruits and vegetables may reduce the risk of peripheral artery disease, according to a study of more than 3.6 million individuals in the U.S. (Source: Reuters: Health)
Source: Reuters: Health - May 24, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 22, 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. BoneSupport launches trial of antibiotic-eluting bone graft BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft su...
Source: Mass Device - May 22, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

QT Vascular shops coronary assets
QT Vascular said today that it’s in discussions to sell its coronary assets, apart from the Chocolate PTA device it’s already looking to deal to Medtronic (NYSE:MDT). Earlier this month, QT Vascular said Medtronic agreed to pay $28 million for an option on the Chocolate PTA non-drug-coated balloon for treating peripheral vascular disease, after inking a 5-year deal in February calling for Medtronic to distribute the Chocolate PTA device. Today the Singapore-based company said it’s “currently engaging interested 3rd parties in negotiations for possible transaction(s) involvin...
Source: Mass Device - May 22, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Mergers & Acquisitions Wall Street Beat QT Vascular Source Type: news

Fruits, Veggies May Benefit Your Legs, Too
Healthy diet may provide protection from peripheral artery disease, study says Source: HealthDay Related MedlinePlus Pages: Nutrition, Peripheral Arterial Disease (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 18, 2017 Category: Consumer Health News Source Type: news

'Fat but fit' still at higher risk of heart disease
Conclusion The question of whether someone can be "fat but fit" has been much debated. If you're obese but exercise, eat well and don't have metabolic risk factors, the theory goes, you could be just as healthy as someone of recommended weight. This study suggests that may not be true. It is definitely worth adopting a healthy lifestyle, whatever your weight. The study found that, the more metabolic risk factors people had, the more likely they were to develop heart disease, cardiovascular disease and so on. Metabolic risk factors do make a difference. But in this large study, on average, people who wer...
Source: NHS News Feed - May 17, 2017 Category: Consumer Health News Tags: Food/diet Obesity Source Type: news

Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These procedures can cause target lesion revascularization, requiring the need for repeat treatments. Alucent Medical’s photo-activated drug therapy, NVS, is designed to build natural scaffolding and keep the vessel open, according to the S...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Vascular alucentmedical Source Type: news

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
Based on new data from two large clinical trials, FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your healthcare professional if you have questions or concerns. Do not stop taking your diabete...
Source: FDA Center for Drug Evaluation and Research - What's New - May 16, 2017 Category: Drugs & Pharmacology Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 12, 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. Xtant Medical amends Orbimed credit line to $15m, taps restructuring advisors Xtant Medical said today that it amended its senior credit line with OrbiMed Advisors, saying it plans to use the $15 million facility to pay off the ...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic to acquire QT Vascular ’ s Chocolate PTA peripheral balloon
Medtronic (NYSE:MDT) agreed to acquire an option on the Chocolate PTA non-drug-coated balloon made by QT Vascular to treat peripheral vascular disease. The purchase price is $28 million, according to Singapore’s Business Times, pegged to “achievement of certain milestones,” the company said. In February the companies inked a 5-year deal calling for Medtronic to distribute the Chocolate PTA device. “We are excited that Medtronic, the world’s leading medical device company has taken an interest in our non-drug coated peripheral products,” QT Vascular CEO Eitan Konstantino&nb...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Mergers & Acquisitions Wall Street Beat Medtronic Peripheral Artery Disease QT Vascular Source Type: news

Medtronic options QT Vascular ’ s Chocolate PTA peripheral balloon
Medtronic (NYSE:MDT) agreed to acquire an option on the Chocolate PTA non-drug-coated balloon made by QT Vascular to treat peripheral vascular disease. The purchase price is $28 million, according to Singapore’s Business Times, pegged to “achievement of certain milestones,” the company said. In February the companies inked a 5-year deal calling for Medtronic to distribute the Chocolate PTA device. “We are excited that Medtronic, the world’s leading medical device company has taken an interest in our non-drug coated peripheral products,” QT Vascular CEO Eitan Konstantino&nb...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Mergers & Acquisitions Wall Street Beat Medtronic Peripheral Artery Disease QT Vascular Source Type: news