What & #039;s Next for Bioresorbable Scaffolds?
Even with new data, the future of bioresorbable scaffolds remains in flux. At TCT 2018 in September, Reva Medical and Abbott Laboratories painted differing pictures with their respective bioresorbable scaffold studies. What now? Dr. Lukasz Koltowski from the Medical University of Warsaw in Warsaw, Poland, presented new data from Reva Medical's "Fantom STEMI" pilot study. The study showed procedural success and clinical utility of the Fantom bioresorbable scaffold in nine patients with acute ST-segment elevated myocardial infarction (“STEMI”) heart attacks. "Many heart atta...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: Business Cardiovascular Source Type: news

Bard ’ s peripheral artery stent exceeds acceptable restenosis rate
In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis. At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months. Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries wit...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Stents Vascular BD Clearstream Technologies crbard Source Type: news

BD ’ s Bard updates on higher restenosis rate for LifeStream covered iliac stent
In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis. At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months. Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries wit...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Stents Vascular BD Clearstream Technologies crbard Source Type: news

FDA Okays Rivaroxaban Plus Aspirin for Chronic CAD, PAD FDA Okays Rivaroxaban Plus Aspirin for Chronic CAD, PAD
The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 12, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

12.10.18: Not intended for U.S. and UK Media
U.S. FDA approves Bayer's Xarelto® for patients with coronary or peripheral artery diseaseXarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease / Xarelto, in combination with aspirin, is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient group / Approval in the U.S. follows regulatory clearance in both Europe and Canadamehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - October 12, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA approves Bayer & #8217;s Xarelto ® for patients with coronary or peripheral artery disease (for specialized target groups only)
Xarelto, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease / Xarelto, in combination with aspirin, is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient group / Approval in the U.S. follows regulatory clearance in both Europe and Canada (Source: Bayer Company News)
Source: Bayer Company News - October 12, 2018 Category: Pharmaceuticals Source Type: news

U.S. FDA Approves XARELTO ® (rivaroxaban) to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
(Source: Johnson and Johnson)
Source: Johnson and Johnson - October 11, 2018 Category: Pharmaceuticals Source Type: news

FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
TITUSVILLE, NJ, October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 11, 2018 Category: Drugs & Pharmacology Source Type: news

Managing Peripheral Vascular Disease: A Short Summary of a Long History
A look back at a decade of advances in management of peripheral vascular disease prompted this short summary of big changes. (Source: ConsultantLive)
Source: ConsultantLive - October 10, 2018 Category: Internal Medicine Authors: Gregory W. Rutecki, MD Tags: Cardiovascular Disease Hypertension Source Type: news

AHA: Doctors Could Do More to Help Smokers With Poor Circulation
WEDNESDAY, Oct. 3, 2018 (American Heart Association) -- Doctors are not doing nearly enough to help peripheral artery disease patients quit smoking, a key risk factor for the disease, a new study shows. The study, published Oct. 3 in the Journal of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - October 3, 2018 Category: General Medicine Source Type: news

Cardiovascular Systems touts first OUS use of orbital atherectomy system, eyes shift to revascularization
Cardiovascular Systems (NSDQ:CSII) today touted that its peripheral orbital atherectomy system was used in its first procedure outside the US as the company is reportedly looking to grow its business beyond a single product and towards supplying a full revascularization tool kit. The St. Paul, Minn.-based company said that its Stealth 360 peripheral orbital atherectomy system was used to treat a patient in Hong Kong, which marks the first commercial use of the company’s product outside the US. “We are pleased that the first patient treated with OAS in conjunction with our international distribution partner...
Source: Mass Device - September 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Cardiovascular Systems Inc. Source Type: news

Ra Medical sets range for $50m IPO
Ra Medical yesterday set the terms for its forthcoming initial public offering, which would fetch $50 million at the midpoint. The Carlsbad, Calif.-based company said it plans to float 3.3 million shares at $14 to $16 apiece, for gross proceeds of $46.7 million to $53.3 million. At the midpoint the flotation would gross $50.0 million, according to a new filing with the U.S. Securities & Exchange Commission. That’s well below the more than $86 million Ra Medical indicated in a regulatory filing last month. The company makes the Dabra atherectomy catheter laser to treat patients with peripheral artery disease....
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Funding Roundup Initial Public Offering (IPO) Wall Street Beat peripheral Ra Medical Source Type: news

CWRU receives NIH funding to investigate new imaging approach for peripheral vascular disease
(Case Western Reserve University) Case Western Reserve University School of Medicine has received a three-year, $1,118,556 grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health to investigate a new imaging approach for diagnosing peripheral arterial disease, a common and potentially serious circulatory problem. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 17, 2018 Category: International Medicine & Public Health Source Type: news

Slow Medicine: Overuse of Genetic Testing, Dialysis
(MedPage Today) -- Plus screening for peripheral artery disease and colon cancer surveillance (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 14, 2018 Category: Cardiology Source Type: news

Avinger shareholders accept $5 million settlement
The plaintiffs in a class action suit against Avinger (NSDQ:AVGR) have approved the $5 million settlement that the company offered in March. Shareholders sued the company and several of its officers and directors claiming that they made false and misleading statements about Avinger’s original product, Pantheris, in its 2015 initial public offering. Avinger makes image-guided, catheter-based atherectomy systems for treatment of peripheral artery disease. The company has already paid its $1.75 million portion of the settlement. Avinger sold approximately 5 million shares to members of the public in its IPO at $13....
Source: Mass Device - September 13, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiovascular Catheters Food & Drug Administration (FDA) Initial Public Offering (IPO) Legal News Avinger Source Type: news

Beet juice may reduce walking pain with leg artery disease
(Reuters Health) - Patients with peripheral artery disease who drink beet juice before walking may feel less pain from this type of exercise than people who don't, a small experiment suggests. (Source: Reuters: Health)
Source: Reuters: Health - September 7, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Peripheral artery disease in diabetics can be predicted by AI
Artificial intelligence blood test can predict peripheral artery disease in patients with diabetes, according to research presented at the European Society of Cardiology Congress.Healio (Source: Society for Endocrinology)
Source: Society for Endocrinology - September 7, 2018 Category: Endocrinology Source Type: news

Avinger asks for FDA approval of small-vessel PAD device
Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD). The Pantheris small vessel (SV) device extends the company’s line of  Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to targ...
Source: Mass Device - August 30, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Regulatory/Compliance Vascular Avinger FDA Source Type: news

Ra Medical re-ups $86m IPO registration
Ra Medical has re-upped its registration for an upcoming initial public offering looking to bring in approximately $86.3 million, according to a recently posted SEC filing. Ra Medical produces the Dabra atherectomy catheter laser designed to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the company touts as having significant advantages over traditional balloon angioplasty systems. Ra Medical won FDA 510(k) clearance for the system last May, and CE Mark approval in the European Union in 2016. The C...
Source: Mass Device - August 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Ra Medical Source Type: news

Scientists develop alternative treatment for peripheral artery disease
(Louisiana State University) Cristina Sabliov, LSU Biological and Agricultural Engineering professor, and Tammy Dugas, professor in the LSU School of Veterinary Medicine's Department of Comparative Biomedical Sciences, have joined forces to fight peripheral artery disease, or PAD, an ailment affecting 8 million Americans. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 28, 2018 Category: International Medicine & Public Health Source Type: news

EC Approves Rivaroxaban Plus Aspirin Regimen for CAD, PAD EC Approves Rivaroxaban Plus Aspirin Regimen for CAD, PAD
The rivaroxaban/aspirin combination is for the prevention of thrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 27, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

24.08.18: Not intended for U.S. and UK Media
Bayer secures approval in the EU for Xarelto® (rivaroxaban) for patients with coronary or peripheral artery diseaseXarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events / Launch first expected in Germanymehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - August 24, 2018 Category: Pharmaceuticals Source Type: news

Bayer secures approval in the EU for Xarelto ® (rivaroxaban) for patients with coronary or peripheral artery disease (for specialized target groups only)
Xarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk for ischemic events / Launch first expected in Germany (Source: Bayer Company News)
Source: Bayer Company News - August 24, 2018 Category: Pharmaceuticals Source Type: news

Closing the Racial Disparity in PAD Care
(MedPage Today) -- African Americans fare worse with peripheral artery disease (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - August 19, 2018 Category: Primary Care Source Type: news

Amputation Not Best Option for Circulation Woes?
Critical limb ischemia is the most severe form of peripheral artery disease (PAD) and can lead to ulcers, gangrene and amputation, the researchers said. (Source: WebMD Health)
Source: WebMD Health - August 15, 2018 Category: Consumer Health News Source Type: news

Medtronic launches In.Pact Admiral drug-coated balloon in Japan
Medtech titan Medtronic (NYSE:MDT) said today that it launched its In.Pact Admiral drug-coated balloon in Japan. The company won approval and reimbursement for its device last year from the Japanese Ministry of Health, Labor and Welfare for the treatment of peripheral artery disease in the upper leg. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic launches In.Pact Admiral drug-coated balloon in Japan appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - August 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Vascular Wall Street Beat Medtronic Source Type: news

NuCryo Vascular inks PolarCath distro deal with Lokai Medical
Privately held cryoplasty developer NuCryo Vascular said today it inked a deal with Lokai Medical to distribute its PolarCath balloon dilation system in the US. San Jose, Calif.-based NuCryo Vascular’s PolarCath system is designed to be used in Balloon Cryoplasty procedures to treat peripheral artery disease. The system has FDA approval and is cleared to dilate stenosis in the peripheral vasculature and for treating obstructive lesions of polytetrafluorethylene access grafts or arteriovenous dialysis fistulae, the company said The PolarCath, which won clearance initially in 2002, was purchased along with the company ...
Source: Mass Device - August 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Catheters Distribution Vascular Boston Scientific NuCryo Vascular Source Type: news

Cardiovascular Systems touts 2-year Liberty 360 PAD study data
Cardiovascular Systems (NSDQ:CSII) yesterday released two-year results from the Liberty 360 study examining long-term clinical and economic outcomes for peripheral vascular interventions in treating patients with peripheral artery disease. Results from the trial were presented by Dr. Jihad Mustapha of Grand Rapids, Mich.’s Advanced Cardiac & Vascular Amputation Prevention Centers in a late-breaking presentation at the 2018 Amputation Prevention Symposium in Chicago. In the 1,204-patient “all comers” study, investigators examined effects of treatment with a number of different FDA-cleared devices ...
Source: Mass Device - August 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Cardiovascular Systems Inc. Source Type: news

AHA: Obesity May Increase Risk for Peripheral Artery Disease
THURSDAY, Aug. 9, 2018 (American Heart Association) -- People with obesity are known to be at increased risk for coronary heart disease, the most common type of heart disease. Now, a new study shows obesity may also increase the chance of developing... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 9, 2018 Category: General Medicine Source Type: news

Fewer Dialysis Patients Facing Leg Amputations
Patients with kidney disease have a higher risk for losing a leg because they have an increased risk for peripheral artery disease, which occurs when there's not enough blood reaching the legs. (Source: WebMD Health)
Source: WebMD Health - July 31, 2018 Category: Consumer Health News Source Type: news

Are Bioresorbable Stents Destined for a Comeback?
The excitement around bioresorbable stents might have calmed down considerably over the last year, but all that could change. Reva Medical, a San Diego, CA-based company is bringing the technology back into the spotlight with a recent approval. The company has received a CE mark for its Motiv bioresorbable scaffold to be used for the treatment of below-the-knee (BTK) peripheral artery disease (PAD). The CE mark is also significant for Reva because it marks the company’s entry into the PAD space. The company already has CE mark for its Fantom bioresorbable scaffold, which treats patients for coronary arter...
Source: MDDI - July 31, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Cardiovascular Systems shares steady on Q4, FY2018 earnings beat
Shares in Cardiovascular Systems (NSDQ:CSII) have stayed steady in after-hours trading after the medical device maker posted full year and fourth quarter fiscal year 2018 earnings that beat expectations on Wall Street. The St. Paul, Minn.-based company posted profits of $3.7 million, or 11¢ per share, on sales of $59.2 million for the three months June 30, seeing massive 384.1% growth on the bottom-line while sales grew 11.8% compared with the same period during the previous year. Earnings per share beat the 6¢ expectations on Wall Street, where analysts expected too see sales of $58.2 million, which the com...
Source: Mass Device - July 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Cardiovascular Systems Inc. Source Type: news

27.07.18: Not intended for U.S. and UK Media
Bayer receives positive CHMP opinion for rivaroxaban for patients with coronary or peripheral artery diseasePositive CHMP opinion based on data from the largest Phase III rivaroxaban study, COMPASS / Once approved, rivaroxaban will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic eventsmehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - July 27, 2018 Category: Pharmaceuticals Source Type: news

Bayer receives positive CHMP opinion for rivaroxaban for patients with coronary or peripheral artery disease (for specialized target groups only)
Positive CHMP opinion based on data from the largest Phase III rivaroxaban study, COMPASS / Once approved, rivaroxaban will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events (Source: Bayer Company News)
Source: Bayer Company News - July 27, 2018 Category: Pharmaceuticals Source Type: news

Reva wins CE Mark for bioresorbable scaffold in below-the-knee PAD
Reva Medical (ASX:RVA) said yesterday it won CE Mark approval in the European Union for its Motiv bioresorbable drug-eluting scaffold, now cleared for treatment of below-the-knee peripheral artery disease. The San Diego-based company’s Motiv is made from the company’s proprietary radiopaque Tyrocore polymer designed for vascular scaffolds. Reva said that over the coming months, it will select centers to analyze the device’s performance for future user and other applications. Read the whole story on our sister site, Drug Delivery Business News The post Reva wins CE Mark for bioresorbable scaffold in b...
Source: Mass Device - July 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Drug-Device Combinations Drug-Eluting Stents Regulatory/Compliance Vascular Reva Medical Inc. Source Type: news

Ra Medical registers for $87m IPO
Ra Medical yesterday registered for an initial public offering worth up to $86.5 million, according to a recently posted SEC filing. The Carlsbad, Calif.-based company said it plans to list on the New York Stock Exchange under the symbol “RMED,” according to the SEC posting. Piper Jaffray and Cantor Fitzgerald are acting as joint book runners for the offering, according to the filing. Ra Medical produces the Dabra atherectomy catheter laser designed to treat patients with peripheral artery disease. The system is designed to destroy arteriosclerotic blockages through the use of radiation ablation, which the...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Initial Public Offering (IPO) Ra Medical Source Type: news

Avenger receives FDA approval for Pantheris altherectomy device
Avinger (Redwood City, Calif.) recently received FDA approval for its Pantheris image-guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be approved for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and can shave plaque without causing damage to blood vessels. The device can also be used by physicians to use the real-time intravascular imaging tool to identify features of blood vessels, include necrotic cores, fibroatheromas, calcium and stent struts. Get the full sto...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Avinger Source Type: news

Avinger receives FDA approval for Pantheris altherectomy device
Avinger (Redwood City, Calif.) recently received FDA approval for its Pantheris image-guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be approved for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and can shave plaque without causing damage to blood vessels. The device can also be used by physicians to use the real-time intravascular imaging tool to identify features of blood vessels, include necrotic cores, fibroatheromas, calcium and stent struts. Get the full sto...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Avinger Source Type: news

Cagent Vascular closes $12m Series B
Cagent Vascular said today it closed a $11.9 million Series B round of financing to help support expand manufacturing and a limited launch of the company’s Serranator Alto angioplasty device. The round was led by two strategic investors and joined by Balestier Investments, Ben Franklin Technology Partners, Synergy Ventures and other private investors, the Wayne, Penn.-based company said. Cagent Vascular’s Serranator is an angioplasty device that uses serrated metal strips on a semi-complaint balloon to create multiple longitudinal lines of micro-serrations within the luminal surface to aid in arterial expa...
Source: Mass Device - July 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Cagent Vascular Source Type: news

USPSTF: Evidence Lacking for ABI for PAD Screen in Asymptomatic
WEDNESDAY, July 11, 2018 -- The U.S. Preventive Services Task Force (USPSTF) concludes that there is currently insufficient evidence to assess the benefits and harms of screening for peripheral artery disease (PAD) with the ankle branchial index... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 11, 2018 Category: Pharmaceuticals Source Type: news

Medical News Today: What to know about peripheral vascular disease
Peripheral vascular disease (PVD) is when there is restricted blood flow to the limbs. Symptoms usually affect the legs, causing pain, cramps, and pale or blue skin. People who are over 50, have diabetes, or smoke cigarettes are more at risk of PVD. Read on to learn about the causes, symptoms, and treatment for PVD. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 19, 2018 Category: Consumer Health News Tags: Cardiovascular / Cardiology Source Type: news

Medtronic Receives FDA Approval for 200mm and 250mm IN.PACT(TM) Admiral(TM) Drug Coated Balloons
New, Extended Balloon Lengths Enable Physicians to Efficiently Treat Long SFA Lesions DUBLIN - June 15, 2018 - Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm lengths of... Devices, Interventional, FDA Medtronic, IN.PACT Admiral, Drug-Coated Balloon, peripheral artery disease (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 15, 2018 Category: Pharmaceuticals Source Type: news

Avinger launches post-market study comparing OCT to IVUS in PAD treatments
Avinger (NSDQ:AVGR) said today it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries. The Redwood City, Calif.-based company’s Lumivascular tech, including its Pantheris image-guided atherectomy device and Ocelot image-guided chronic total occlusion crossing catheters, use OCT for real-time intravascular imaging during interventions to treat peripheral artery disease. “As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intrava...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Imaging Vascular Avinger Source Type: news

World No Tobacco Day 2018: Tobacco breaks hearts
Cairo, Egypt, 31 May – Every year, on 31 May, the World Health Organization (WHO) and partners mark World No Tobacco Day, highlighting the health and other risks associated with tobacco use, and advocating for effective policies to reduce tobacco consumption. This year, World No Tobacco Day focuses on tobacco and heart disease. The campaign’s slogan is “Tobacco breaks hearts. Choose health, not tobacco”. Tobacco use is one of the leading causes of premature death and disability worldwide. It is also a key risk factor for the development of coronary heart disease, stroke and peripheral vascular dise...
Source: WHO EMRO News - May 26, 2018 Category: Middle East Health Source Type: news

Avinger wins FDA nod for next-gen Pantheris
Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease. Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added. “We are exci...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance Vascular Avinger Source Type: news

Statins in Peripheral Artery Disease: Why Are We Waiting? Statins in Peripheral Artery Disease: Why Are We Waiting?
Should high-intensity statin therapy be prescribed for patients with atherosclerotic peripheral artery disease?Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 21, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Nigeria:Tobacco Consumption Contributes 12% Deaths From Heart Diseases - NHF
[This Day] Tobacco use and second-hand smoke is a major risk factor for cardiovascular disease (CVD), including coronary heart disease, stroke and peripheral vascular disease; contributing about 12 per cent death from heart disease, the Nigerian Heart Foundation (NHF), has said. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - May 17, 2018 Category: African Health Source Type: news

SurModics acquires Embolitech thrombectomy tech for $5m
SurModics (NSDQ:SRDX) said today it inked a deal with Embolitech to acquire its thrombectomy platform the and associated intellectual property in a deal worth $5 million up front, with additional payments based on regulatory milestones. The newly acquired tech platform is designed for use in the peripheral vasculature to remove hard blood clots, Eden Prairie, Minn.-based SurModics said. SurModics added that it plans to leverage its design, development and manufacturing capabilities to advance the platform into different peripheral and vascular applications. “We are pleased to sign an agreement with Surmodic...
Source: Mass Device - May 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Mergers & Acquisitions Vascular SurModics Inc. Source Type: news