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

Seated 32 km away, city doctor fixes woman's heart
Dr Tejas Patel creates history, performs angioplasty remotely from Akshardham temple on his patient in a lab connected through internet (Source: The Economic Times)
Source: The Economic Times - December 6, 2018 Category: Consumer Health News Source Type: news

New Corindus Technology Successfully Used in Robotic-Assisted Coronary Intervention
The future of robotic-assisted surgery emerges ever closer with the news of Corindus Vascular Robotics's new CorPath GRX System being successfully used to enable robotic-assisted percutaneous coronary interventions (PCI) at the recent Transcatheter Cardiovascular Therapeutics 2018 (TCT) conference. The technology was used to perform the first live transmission of a hybrid chronic total occlusion PCI using both manual and robotic techniques to successfully treat a patient suffering from a complete coronary artery blockage. The CorPath System is described by the company as the first and only FDA-cleared medical device that c...
Source: MDDI - December 1, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: Cardiovascular Source Type: news

ECG Educational Standards for Prehospital Providers
Conclusion As the role of evidence-based medicine becomes more prominent in the field of emergency medicine, a clear view of the current state of ECG education and platform from which to implement uniform standards becomes increasingly essential; especially as research expands into the prehospital setting. Further research into EMS education may identify both strengths and weaknesses in basic ECG interpretation appropriate for first responders. Implementing minimum ECG interpretation standards for EMS personnel nationwide is one potential option to ensure prehospital educational institutions stay responsive to current scie...
Source: JEMS Special Topics - November 27, 2018 Category: Emergency Medicine Authors: Jonathan Barney, BA, EMT, MS3 Tags: Training Exclusive Articles Cardiac & Resuscitation Source Type: news

Residual inflammation risk affects outcomes after percutaneous coronary intervention
(European Society of Cardiology) Patients who have persistently high levels of inflammation following percutaneous coronary intervention (PCI) for coronary artery disease are significantly more likely to die from any cause or to have a heart attack within a year, according to a study of 7,026 patients published in the European Heart Journal. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 19, 2018 Category: International Medicine & Public Health Source Type: news

Philips Takes a Firm Stand in the DCB Market with ILLUMENATE
This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation." Layout of the Land C.R. Bard once held the crown in the DCB market, having gained approval for its Lutonix technology in 2014. The Murray Hill, NJ-based company began losing share when Medtronic launched the IN.PACT Admiral in early 2015. (Ed...
Source: MDDI - November 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Medtronic's Valiant Navion Thoracic Stent Graft System Garners Both FDA and CE Mark Approvals
Only three weeks ago, Medtronic's Valiant Navion ™ Thoracic Stent Graft System received FDA approval. Today, the company announced that its low profile device now has been approved for the CE Mark in Europe as well. According to Medtronic, this lower profile stent graft, which was eight years in the making, now makes it possible to use as a trea tment in the broadest possible patient population, especially in those whose anatomy would not permit thoracic endovascular aneurysm repair (TEVAR), such as patients with narrower or more curved iliac arteries, most commonly female. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 13, 2018 Category: Cardiology Source Type: news

Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon. The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia. Get the full story at our sister site, Drug Delivery Business News. The post Philips launches below-the-knee PAD trial for drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Royal Philips Source Type: news

5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
At last week's Vascular Interventional Advances (VIVA) Annual Meeting in Las Vegas, Medtronic presented five-year final outcomes from its IN.PACT SFA Trial. Of note: Medtronic is the first company to present long-term five-year outcomes for a commercially-available drug-coated balloon (DCB). The data not only reinforced the safety, durability, and efficacy of the IN.PACT Admiral DCB, as seen in previous studies, but also reaffirmed its use as a frontline therapy for the treatment of peripheral artery disease (PAD). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 13, 2018 Category: Cardiology Source Type: news

Cardiovascular Systems enters Chinese market through OrbusNeich deal
Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich. St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong. “Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap o...
Source: Mass Device - November 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Distribution Cardiovascular Systems Inc. OrbusNeich Source Type: news

Trial shows BD balloon compares well with angioplasty for CLI
BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee. The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb through 30 days—was met in both the proportional and binary and Kaplan Meier analyses of patient survival following a medical procedure. BD presented the trial results during a l...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Catheters Clinical Trials Featured Research & Development Vascular BD Vascular Interventional Advances (VIVA) Source Type: news

VentureMed launches Flex scoring catheter study
Vascular focused device developer VentureMed said yesterday that it launched a new study of its Flex dynamic scoring catheter, exploring whether the device reduces dissections and the need for bailout stents in peripheral arteries. In the newly launched iDissection Classification study, investigators will use intravascular ultrasound to identify the health of vessels after treatment with the Flex system, the Toledo, Ohio-based company said. The trial is being led by Dr. Nicolas Shammas of Davenport, Iowa’s Midwest Cardiovascular Research Foundation, who led the previous iDissection study. In the previous st...
Source: Mass Device - November 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Vascular venturemed Source Type: news

Intact Vascular Has Strong Data from TOBA II
One-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) successfully achieved both its primary and secondary endpoints. The Wayne, PA-based company announced the results at the 15th annual VIVA conference in Las Vegas. The company said this is the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disea...
Source: MDDI - November 7, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

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

New Data for IN.PACT Drug-Coated Balloon Show Sizable Advantage Over Standard PTA in Peripherals
Dual presentations, made at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings in San Diego and Lisbon, showed significant superiority of Medtronic's IN.PACT Admiral drug-coated balloon (DCB) over standard Percutaneous Transluminal Angioplasty (PTA). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - October 2, 2018 Category: Cardiology Source Type: news

Common Diabetes Meds May Raise Odds for Amputation
For people with type 2 diabetes, taking a diuretic raised the odds of having an amputation, or requiring an angioplasty or bypass, by 75 percent or more, compared with those not using the medicines, researchers said this week. (Source: WebMD Health)
Source: WebMD Health - October 2, 2018 Category: Consumer Health News 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

FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection. Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January. A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said. “We are thrilled to have achieved this milestone for the first of several device...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news

FDA clears 1st acute coronary artery perforation stent in 17 years
The FDA said today it approved Biotronik’s PK Papyrus covered coronary stent system intended to treat acute coronary artery perforations, touting it as the first such device to win clearance for that indication in 17 years. Coronary artery perforations can occur during percutaneous coronary intervention procedures and can create life-threatening conditions, the FDA said. In some such perforations, blood can leak through the tear and lead to a collection of blood in the sac surrounding the heart, putting a patient’s life at serious risk. The newly cleared PK Papyrus is a balloon-expandable covered coronary stent...
Source: Mass Device - September 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Stents Biotronik Source Type: news

FDA Approves First New Device for Heart Vessel Tears in 17 Years
  Cardiologists have a new tool for handling a rare but potentially life-threatening complication during percutaneous coronary intervention (PCI) procedures. FDA approved Biotronik's PK Papyrus Covered Coronary Stent System as a treatment for tears in the coronary arteries that can occur during heart vessel procedures. The PK Papyrus System is the first device FDA has approved for this indication in 17 years. The device has been CE marked for sale in Europe since 2013. "The PK Papyrus Covered Coronary Stent System provides healthcare providers with a new treatment option...
Source: MDDI - September 14, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Acute myocardial infarction secondary to blunt chest trauma in motorcycle accident: a rare combination where percutaneous coronary intervention and intravascular imaging optimization are needed - Boi A, Sanna F, Rossi A, Loi B.
Blunt chest trauma is a common occurrence in vehicle accident. Cardiac injuries following nonpenetrating thoracic trauma have been reported. ST-elevation myocardial infarction (STEMI) due to coronary artery involvement is a rare but extremely serious condi... (Source: SafetyLit)
Source: SafetyLit - September 14, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Women are a FIFTH more likely to die after routine surgery for coronary heart disease
EXCLUSIVE Researchers from Keele University analysed 6.6 million patients over 10 years and found women who have a percutaneous coronary intervention are more at risk than men. (Source: the Mail online | Health)
Source: the Mail online | Health - September 10, 2018 Category: Consumer Health News Source Type: news

Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent thrombosis following DAPT interruption or discontinuation after one month with a next-gen drug-eluting stent, according to Medtronic. Get the full story at our sister site, Drug Delivery Business News. The post Medtronic launches one-month DAPT study for dr...
Source: Mass Device - September 10, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Stents Pharmaceuticals Wall Street Beat Medtronic Source Type: news

Intravascular ultrasound-guided percutaneous coronary intervention: An updated review
(Cardiovascular Innovations and Applications) In the current issue of Cardiovascular Innovations and Applications (Volume3, Number 2, 2018, pp. 127-136(10); DOI, Dhruv Mahtta, Ahmed N. Mahmoud, Mohammad K. Mojadidi and Islam Y. Elgendy from the University of Florida, Gainesville, Fla., USA consider intravascular ultrasound-guided percutaneous coronary intervention. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 10, 2018 Category: International Medicine & Public Health 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

MicroPort < sup > ® < /sup > Firefighter ™ PTCA Balloon Catheter Obtains Approval for Registration in Mexico
(Source: Microport News Release)
Source: Microport News Release - August 15, 2018 Category: Medical Devices Source Type: news

Do You Know How to Manage Japan ’s Revised Reimbursement Approach?
One significant change in Japan’s revised reimbursement process for new medical devices involves pricing. Applicants have been required for some time to provide pricing for their medical devices in other primary markets such as the United States, the United Kingdom, Germany, France, and Australia. Pricing has been based on list price, not market price, and the intention was to cap the reimbursement of medical devices. Given the typical differences between U.S. pricing and European pricing, the high U.S. price tended to pull the average up. (Please see the example below in Table 1; each price is converted ...
Source: MDDI - July 27, 2018 Category: Medical Devices Authors: Keisuke Suzuki Tags: Regulatory and Compliance Source Type: news

Five-Year Stroke Rates Lower After PCI Versus CABG
WEDNESDAY, July 18, 2018 -- Stroke rates are lower at 30 days and five years after percutaneous coronary intervention (PCI) than after coronary artery bypass grafting (CABG), according to a study published in the July 24 issue of the Journal of the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 18, 2018 Category: Pharmaceuticals Source Type: news