Open Heart Surgery Beats Stents for Multivessel Disease
FRIDAY, May 17, 2019 -- Coronary artery bypass graft (CABG) surgery may be a better treatment option than percutaneous coronary intervention (PCI) for most patients with more than one blocked heart artery, according to a study published online May 1... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 17, 2019 Category: Pharmaceuticals Source Type: news

Corindus Misses Expectations, But Still Embraced by Wall Street
Corindus Vascular Robotics missed earnings per share expectations by one cent, but Wall Street didn’t seem to mind as shares of the medtech company, which was a 2015 MDEA finalist, soared on Wednesday. At one-point shares were up by as much as 23%. The surgical robotics maker reported 1Q19 EPS of $0.05 against the analyst estimate of $0.04. Revenue for 1Q19 was $3 million vs. the consensus estimate of $3.11 million. The Waltham, MA-based company recorded purchase orders for 11 CorPath GRX Systems, an increase of 83% compared to purchase orders received in 4Q18 and 267% growth compared to the purchase orde...
Source: MDDI - May 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Could Better Materials Lead to Better Outcomes with DCBs?
Boston University School of Medicine (BUSM) researchers are examining drug-coated balloon catheters at a microscopic level in hopes of producing more efficient alternatives for treating arterial disease. The researchers are specifically looking at the coatings of the devices. Obstructive arterial disease is a clinical challenge affecting millions of people in the world. Devices such as stents and balloon catheters are the primary choice for treating these narrowed vessels. While the use of stents is beneficial in many cases, once implanted, they remain in the body permanently. Presence of such foreign bodies inside an arte...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Materials Source Type: news

Bringing Japanese Know-How to the Global Market: A Visit to Shimadzu Medical Systems
TCROSS NEWS and its global partner, Angioplasty.Org, visited Shimadzu Corporation, a major Japanese company founded in 1875, to learn about its plans for future overseas business development of its angiography systems. We saw demonstrations of the Trinias Angiography System, the SCORE StentView software and more. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 24, 2019 Category: Cardiology Source Type: news

PCI Beneficial for All Categories of Older AMI Patients
WEDNESDAY, April 24, 2019 -- For older patients with acute myocardial infarction (AMI), percutaneous coronary intervention (PCI) is beneficial across age strata, according to a research letter published online April 23 in Circulation: Cardiovascular... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 24, 2019 Category: Pharmaceuticals Source Type: news

Non-Adherence to Antiplatelet Therapy After PCI Ups Risk of MACE in Anemic Patients Non-Adherence to Antiplatelet Therapy After PCI Ups Risk of MACE in Anemic Patients
In anemic patients who have undergone percutaneous coronary intervention (PCI), non-adherence to dual antiplatelet therapy (DAPT) - but not physician-recommended discontinuation - is associated with a higher risk of major adverse cardiovascular events (MACE) in the two years following the procedure, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 23, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 15, 2019 Category: Health Management Authors: John George Source Type: news

FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday. The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels. "Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2019 Category: Biotechnology Authors: John George Source Type: news

FDA approves Intact Vascular ’ s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news

Study: Heart attack patients over 65 less likely to get angioplasty
People over age 65 who suffer a heart attack are less likely to be treated with angioplasty than younger patients, a new study shows. (Source: Health News - UPI.com)
Source: Health News - UPI.com - April 8, 2019 Category: Consumer Health News Source Type: news

Seniors Less Likely to Receive or Have Timely PCI for Acute MI
MONDAY, April 8, 2019 -- Seniors with acute myocardial infarction (AMI) are less likely to undergo percutaneous coronary intervention (PCI) or receive PCI in a timely manner, according to a study presented at the American Heart Association Quality... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 8, 2019 Category: Pharmaceuticals Source Type: news

Why Do Older Heart Attack Patients Get Worse Care?
SATURDAY, April 6, 2019 -- If you're over 65 and have a heart attack, your care may be compromised, a new study finds. In fact, you're less apt than younger patients to receive a timely angioplasty to open blocked arteries. You're also likely to... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 6, 2019 Category: General Medicine Source Type: news

UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million. The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock. Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR. “The Enroute system is part of the d...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. Source Type: news

TherOx wins FDA approval for SuperSaturated Oxygen therapy
TherOx said today that it won pre-market approval from the FDA for its SuperSaturated Oxygen Therapy system for acute myocardial infarction. Irvine, Calif.-based TherOx touted the PMA as the first heart attack treatment approved to reduce infarct size since the federal safety watchdog OK’d percutaneous coronary interventions. Indicated for patients suffering from left anterior descending ST-elevation myocardial infarction – the most deadly form of heart attack, known colloquially as the “widowmaker” – within six hours of onset and after stenting, SSO2 therapy delivers hyperbaric levels of oxyg...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Regulatory/Compliance Wall Street Beat TherOx Inc Source Type: news

Silk Road Medical upsizes IPO
Silk Road Medical today boosted the size of its pending initial public offering to as much as $120 million. When it registered the IPO in March, Silk Road said it could fetch as much as $86 million. But last week the Sunnyvale, Calif.-based company cut the range, saying it planned to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million. Today Silk Road said it plans to offer 6 million shares at $19 to $20 a piece, which would deliver gross proceeds of $114 million to $120 million. The company developed the Enroute transcarotid stent and neuroprotection system to treat c...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Wall Street Beat Silk Road Medical Inc. Source Type: news

Silk Road Medical sets downsized range for IPO
Silk Road Medical yesterday set the range on its forthcoming initial public offering, which would fetch $75 million at the midpoint. The Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system is designed to treat carotid artery blockages before they cause a stroke. When it registered the IPO earlier this month, Silk Road said it could fetch as much as $86 million. But yesterday the company said it plans to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million. Silk Road has said it plans to use the cash to expand its sales force and...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Funding Roundup Wall Street Beat Silk Road Medical Inc. Source Type: news

Meet the Robot That Can Help Perform Angioplasty
There's a new surgical robot on the market in Europe and the Middle East, and this one can assist in stenting procedures such as angioplasty. Rouen, France-based Robocath developed R-One, which is the first European robotic solution to obtain the CE mark in the field of interventional cardiology. R-One is designed to enable precision technologies that complement existing methods, in order to improve procedures and the working environment. The company said the device uses a unique technology that optimizes the safety of robotic-assisted coronary angioplasty. The R-One has an open architecture so it i...
Source: MDDI - March 18, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Radial, femoral access for PCI found equal in terms of survival
(American College of Cardiology) Doctors can use either an artery in the arm (the radial approach) or in the groin (the femoral approach) to safely perform percutaneous coronary intervention (PCI) on patients presenting with a heart attack, according to research presented at the American College of Cardiology's 68th Annual Scientific Session. The research, which was stopped early, suggests the radial and femoral approach are equivalent in terms of the risk of death at 30 days. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 18, 2019 Category: International Medicine & Public Health Source Type: news

CRF research to be presented at ACC.19
(Cardiovascular Research Foundation) Research from the Cardiovascular Research Foundation and the CRF Clinical Trials Center will be presented at the American College of Cardiology's 68th Annual Scientific Session taking place March 16-18, 2019 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. They will be presenting the latest data on percutaneous coronary intervention (PCI), imaging technologies, renal denervation, and transcatheter aortic valve replacement. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 14, 2019 Category: International Medicine & Public Health Source Type: news

Is the Paclitaxel Narrative Getting Worse?
Paclitaxel drug-coated balloons and drug-eluting stents received some bad press in January after a meta-analysis showed an increased risk of death for patients treated with these devices in the femoral and/or popliteal arteries of the lower limbs. Two drug-eluting device trials were paused after the analysis was published in the Journal of the American Heart Association and the data prompted FDA to investigate. Mike Matson, a medtech analyst at Needham & Co., issued a report in February pointing to evidence and expert opinion that the benefits of using paclitaxel balloons and stents outweigh the risks. Now,...
Source: MDDI - March 13, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

PCI in Stable Coronary Artery Disease: Still in Equipoise? PCI in Stable Coronary Artery Disease: Still in Equipoise?
The benefits of percutaneous coronary intervention remain controversial in patients with stable coronary artery disease. What insights does a recent study add?European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 11, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Saranas ’ Early Bird catches nod from FDA
Saranas said today that FDA has granted its Early Bird endovascular bleed monitoring system de novo designation. The Early Bird device includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR, large-bore hemodynamic support device placement, or other complex cardiovascular interventions in which the femoral artery or vein is used to obtain vascular access. The technology was invented at the Texas Heart Institute. A recent study of more than 17,000 large-bore transcatheter interventions from ...
Source: Mass Device - March 6, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Featured Food & Drug Administration (FDA) News Well Patient Monitoring saranas Source Type: news

A New Way of Looking at Things
It can get pretty crowded in an interventional procedure room, specifically for those places where image-guided therapy is being conducted. “Some of these procedures may require upwards of 15—or sometimes even 20—people in the suite,” said Barry T. Katzen, MD, founder and chief medical executive of Miami Cardiac & Vascular Institute, part of Baptist Health South Florida, in an interview with MD+DI. “And all of them have certain needs for technology, for space, for visualization, and things like that.” He noted th...
Source: MDDI - March 4, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Imaging Source Type: news

Transradial-Access CTO PCI Tied to Less Bleeding vs Other PCI Approaches (CME/CE)
(MedPage Today) -- Big shift in how centers perform chronic total occlusion percutaneous coronary intervention, large study shows (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - March 1, 2019 Category: Cardiology Source Type: news

Whatcom County Faces Challenges Despite Improvements Resulting from a Bundle of Care Approach to OHCA
Whatcom County, Washington, is the furthermost northwest county in the continental United States. The county covers over 2,200 square miles and has a population of approximately 250,000 people, of which 150,000 are within the city of Bellingham. Whatcom County is the state’s 12th largest county, part of which is only accessible by land through Canada. Whatcom County’s ALS program began in 1974. Over the years, the manner in which care has been delivered has steadily improved. In 1996, all BLS response units were equipped with an AED and a strong community effort to provide CPR training was initiated. Then, in ...
Source: JEMS Patient Care - February 27, 2019 Category: Emergency Medicine Authors: Marvin Wayne, MD, FACEP, FAAEM, FAHA Tags: Cardiac & Resuscitation Top Story Exclusive Articles Patient Care Heart of America Source Type: news

FDA Approves Medtronic's Resolute Drug-Eluting Stent Platform for Treatment of Chronic Total Occlusions
The FDA today approved an expanded indication for Medtronic's family of Resolute zotarolimus-eluting coronary stents: use in the treatment of de novo chronic total occlusions (CTO). This approval includes all Resolute DES devices, including the Resolute Onyx ™ and Resolute Integrity™ DES. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 27, 2019 Category: Cardiology Source Type: news

Medtronic Keeps DES Market Hot with New Indication
Rumblings in the Drug-Eluting Stent market continued this week after Medtronic said it has obtained FDA approval for an additional indication for its Resolute DES platform and the Resolute Integrity. The Dublin-based company’s new indication is for the treatment of patients with coronary disease who have de novo chronic total occlusion (CTO), a complex vessel condition involving complete blockage of a coronary artery. CTO is considered more difficult to treat with percutaneous coronary intervention (PCI) due to a greater risk of complications. The expanded CTO indication was supported by data from the PER...
Source: MDDI - February 26, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook Medical‘s Zilver PTX stent was 10.2% and 16.9% for the PTA group. But the correction reversed those numbers. Get the full story at our sister site, Drug Delivery Business News. The post Late mortali...
Source: Mass Device - February 21, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Boston Scientific Cook Medical Medtronic Source Type: news

Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five years. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 19, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Regulatory/Compliance Wall Street Beat Medtronic Source Type: news

Postconditioning During PCI for STEMI Shows Delayed Benefits
THURSDAY, Feb. 7, 2019 -- The benefits of postconditioning (PostC) balloon inflations in patients with ST-segment-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) may not be apparent immediately, according... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 7, 2019 Category: Pharmaceuticals Source Type: news

CathWorks raises $30m in Series C
CathWorks said today that it closed a $30 million Series C round of financing to support its FFRangio non-invasive fractional flow reserve tech. The FFRangio system is designed to provide objective FFR guidance for optimizing percutaneous coronary intervention therapy decisions, the Israel-based company said. FFRangio is derived from routine X-rays during diagnostic angiogram procedures and is performed intra-procedurally during coronary angiography to reduce risk and cost associated with invasive FFR. “We are excited for the investment to support FFRangio market entry and continue with technical and clinic...
Source: Mass Device - February 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Diagnostics Wall Street Beat cathworks Source Type: news

Drug-Coated Balloons Superior After 5 Years in PAD
(MedPage Today) -- Paclitaxel balloon found superior in keeping leg arteries open compared with plain angioplasty (Source: MedPage Today Radiology)
Source: MedPage Today Radiology - February 2, 2019 Category: Radiology Source Type: news

Medtronic Valiant ™ Captivia™ Demonstrates Durability, Safety, and Efficacy at Five Years in Transection Patients
Medtronic plc (NYSE:MDT) announced new data supporting the long-term durability, safety, and efficacy of the Valiant ™ Captivia™ thoracic stent graft system for the treatment of blunt thoracic aortic injury (BTAI). The presentation by Himanshu J. Patel, M.D., University of Michigan Department of Cardiac Surgery at The Society of Thoracic Surgeons Annual Meeting, was the first and only five-year industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - January 31, 2019 Category: Cardiology Source Type: news

Cardiovascular Systems posts Street-beating FY2019 Q2 earnings
Cardiovascular Systems (NSDQ:CSII) today posted fiscal year 2019 second quarter earnings that beat expectations on Wall Street. The St. Paul, Minn.-based company posted profits of $492,000, or 1¢ per share, on sales of approximately $60.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew 14.4% compared with the same period during the previous fiscal year. Earnings per share for the quarter were ahead of the 1¢ loss consensus on Wall Street, where analysts were looking for sales of $59.7 million, which the company also topped. “We are driving...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat Cardiovascular Systems Inc. Source Type: news

Study of VentureMed ’ s Flex catheter begins in Switzerland
Vascular-focused device developer VentureMed said yesterday that it has launched another study of its Flex dynamic scoring catheter, this one to measure how open patients’ blood vessels remain 12 months after treatment. The prospective, single arm, non-randomized study in Switzerland will enroll up to 150 patients whose superficial femoral and popliteal arteries were scored by the Flex system before drug-eluting balloon angioplasty. Flex creates long, parallel, linear micro-incisions in all plaque-lined arteries. Dr. Daniel Périard and Dr. Rolf Engelberger, both of the angiology department at HF...
Source: Mass Device - January 18, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog News Well Research & Development Vascular internationalsymposiumonvasculartherapy venturemed Source Type: news

Innovators of the Coronary Angioplasty Win 2019 Fritz J. and Dolores H. Russ Prize
(National Academies of Sciences, Engineering, and Medicine) The National Academy of Engineering and Ohio University announced today that the 2019 Fritz J. and Dolores H. Russ Prize will be given to Julio Palmaz, Leonard Pinchuk, Richard Schatz, John Simpson, and Paul Yock for innovations leading to the widespread adoption of percutaneous coronary intervention (PCI), previously known as angioplasty with stent or coronary angioplasty. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 9, 2019 Category: International Medicine & Public Health Source Type: news

Coronary artery disease: Angioplasty or bypass surgery?
(Source: MayoClinic.com - Ask a Specialist)
Source: MayoClinic.com - Ask a Specialist - January 9, 2019 Category: Consumer Health News Source Type: news

Abiomed jumps on fiscal Q3 prelims, raised outlook | Wall Street Beat
Abiomed (NSDQ:ABMD) shares got a jump today from its preliminary fiscal third-quarter numbers and an improved outlook for the rest of its fiscal year. The Danvers, Mass.-based heart pump maker said it expects to post fiscal Q3 sales of roughly $200.6 million, representing a 30.3% increase over its fiscal Q3 top line. Abiomed also raised its revenues guidance for fiscal 2019, saying it now expects full-year sales of about $780 million, up from $765 million to $770 million previously. The news sent ABMD shares, which closed up 3.7% at $313.44 apiece Jan. 4, up some 2.1% to $320 even today in pre-market trading. The company s...
Source: Mass Device - January 7, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured MassDevice Earnings Roundup Wall Street Beat Abiomed Cardiovascular Systems Inc. CAS Medical Systems Inc. Nuvasive wrightmedical Source Type: news

Study suggests non-surgical treatment preferable for coronary artery disease
A recent study, published Wednesday in JAMA Cardiology, is the latest to address the effectiveness of angioplasty to treat unprotected left main disease. (Source: Health News - UPI.com)
Source: Health News - UPI.com - January 7, 2019 Category: Consumer Health News Source Type: news

Innovators of Coronary Angioplasty Win 2019 Fritz J. and Dolores H. Russ Prize
The National Academy of Engineering and Ohio University announced today that the 2019 Fritz J. and Dolores H. Russ Prize will be given to Julio Palmaz, Leonard Pinchuk, John Simpson, Richard Schatz, and Paul Yock for innovations leading to the widespread adoption of percutaneous coronary intervention (PCI), previously known as angioplasty with stent or coronary angioplasty. The $500,000 biennial prize, which recognizes a bioengineering achievement that significantly improves the human condition, cites PCI for"seminal contributions to coronary angioplasty, enabling minimally invasive treatment of advanced coronary arte...
Source: News from the National Academies - January 3, 2019 Category: Science Source Type: news

Will Drug-Eluting Devices Suffer from JAHA Publication?
A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA). Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD ...
Source: MDDI - January 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Business Source Type: news

Volumes Low for Unprotected Left Main PCI
WEDNESDAY, Jan. 2, 2019 -- Unprotected left main (ULM) percutaneous coronary intervention (PCI) procedures represented less than 1 percent of all PCIs in clinical practice in the United States from 2009 through 2016, according to a study published... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 2, 2019 Category: Pharmaceuticals Source Type: news

CathWorks wins FDA 510(k) for FFRangio
Non-invasive fractional flow reserve tech developer CathWorks said yesterday that it won FDA 510(k) clearance for its FFRangio non-invasive fractional flow reserve analysis technology. The Israel-based company said that approval came based off of results from the FAST-FFR blinded comparative study study which showed that its FFRangio system was accurate when compared to invasive FFR. “The FDA clearance of CathWorks FFRangio is a significant milestone for interventional cardiologists and the healthcare system overall. It is the first non-invasive device of its kind to receive FDA clearance for use during per...
Source: Mass Device - December 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Vascular cathworks Source Type: news

Upcoding Likely Used to Justify Inappropriate PCI Upcoding Likely Used to Justify Inappropriate PCI
Upcoding of stable chest pain to a diagnosis of unstable angina is likely being used to justify outpatient percutaneous coronary intervention (PCI) that would otherwise be deemed inappropriate, researchers report.Reuters Health Information (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 20, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Upper Valley Medical Center makes another investment
Upper Valley Medical Center, the largest employer in Miami County, continues to invest in its local operations. Most recently, the center expanded the capabilities at its cardiac catheterization lab. As such, individuals experiencing a heart attack and those with non-emergency coronary blockages will benefit from more treatment options. With more capabilities and availability of additional experienced cardiologists, patients who need angioplasty and many types of stents will be able to receive them… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 17, 2018 Category: American Health Authors: Caleb Stephens Source Type: news

Clinical Performance Measures that Matter —Are You Ready?
This article has been revised since it was originally posted on 12/11/2018. Figures 3 and 4 were not correct in the previous version and were replaced on 12/14/2018 at 6:00pm PST. No changes have been made to the text of the article. Ask EMS professionals to define “quality in EMS” and you may get a tip of the head and an answer like, “Well, I’m not sure, but I know it when I see it.” In today’s healthcare environment, demonstrating quality is crucial. Payers are increasingly linking payment to outcome and quality, and becoming less interesting in paying for services that don’t add...
Source: JEMS Special Topics - December 11, 2018 Category: Emergency Medicine Authors: Wayne C. Harbour, NRP Tags: Exclusive Articles Operations Administration and Leadership Source Type: news

Shockwave Announces Collaboration with Abiomed on Physician Training
Shockwave Medical today announced an investment and collaboration agreement with Abiomed, Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and the two companies will collaborate on a training and education program in the United States and Germany focused on the benefits of complementary use of their respective technologies. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - December 11, 2018 Category: Cardiology Source Type: news

FDA clears Contego Medical ’ s Vanguard IEP peripheral balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function. “Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues to expand and become more complex, we believe our technology will play a critical role in protecting vulnerable patients from embolic events and thus improve procedural outcomes.” “The Vanguard IEP System is design...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Featured Food & Drug Administration (FDA) Regulatory/Compliance Contego Medical peripheral Source Type: news

Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
RALEIGH, N.C., Dec. 7, 2018 -- (Healthcare Sales & Marketing Network) -- Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Int... Devices, Interventional, FDA Contego Medical, Vanguard IEP, Peripheral, Angioplasty, embolic protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 7, 2018 Category: Pharmaceuticals Source Type: news

Corindus touts first-in-human coronary telerobotics study with CorPath system
Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India. The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab. In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said. The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Pat...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Robotics Corindus Vascular Robotics Source Type: news