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 (“STEMIâ€) heart attacks.
"Many heart attack patients are...
Source: MDDI - October 16, 2018 Category: Medical Devices Authors: Heather R. Johnson Tags: Business Cardiovascular 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 and del...
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
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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 that...
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 drug-eluting s...
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
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
PCI patients discharged against medical advice twice as likely to be readmitted
(American College of Cardiology) In a new study, researchers found discharge against medical advice as the strongest predictor of 30-day unplanned readmissions in heart attack patients. While only a small number of patients choose to discharge against medical advice following percutaneous coronary intervention (PCI), these patients are twice as likely to be readmitted to the hospital, according to the study published in JACC: Cardiovascular Interventions. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 18, 2018 Category: International Medicine & Public Health Source Type: news
Asahi Intecc to buy RetroVascular for $26m
Asahi Intecc said early this month that its board of directors agreed to acquire RetroVascular in a deal worth approximately $25.9 million.
Menlo Park, Calif.-based RetroVascular is developing cardiological tools for percutaneous transluminal coronary angioplasty procedures, specifically to treat chronic total occlusions.
Asahi said that it has maintained a collaborative relationship with RetroVascular to develop the PTCA treatment, which incorporates the use of plasma energy technology with the intention of improving PTCA treatment results.
Asahi Intecc said it will look for ways to incorporate the plasma energy technolog...
Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions Asahi Intecc Source Type: news
Clotting Time in Transfemoral PCI Linked to Bleeding Risk
WEDNESDAY, June 27, 2018 -- Higher maximal activated clotting time (ACT) is associated with a greater risk of major bleeding after transfemoral (TF) percutaneous coronary intervention (PCI) than after transradial (TR) PCI, according to a study... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 27, 2018 Category: Pharmaceuticals Source Type: news
Corindus wins Japanese PMDA clearance for CorPath GRX platform
Corindus Vascular Robotics (OTC:CVRS) said today it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device.
The CorPath GRX vascular robotics platform is designed to assist cardiologists in performing percutaneous coronary interventions, including angioplasty and stent placement, Corindus said.
“I look forward to offering CorPath GRX to my patients during PCI, especially in complex procedures where precision and procedural control are extremely valuable. We are pleased to be one of the first Asia-Pacific countries to adopt this new and innovative technol...
Source: Mass Device - June 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Robotics Vascular Corindus Vascular Robotics Source Type: news
Consistent CTO: Trial Finds Benefit of PCI for Total Occlusion Consistent CTO: Trial Finds Benefit of PCI for Total Occlusion
Percutaneous coronary intervention opened 90% of complex chronic total occlusions and offered quality-of-life benefits to a contemporary cohort of highly symptomatic patients.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 4, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news
