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 delivery system which is designed to be advanced into the perforated coronary artery vessel using a balloon catheter to provide a physical barrier to seal the tear and allow blood to flow through the device. The FDA said it reviewed the PK Papyrus through a humanitarian device exemption. Data supporting the approval included a real-world survey of 80 patients who received the system to treat coronary artery perforations, which indicated that the system was successfully delivered in 95% of patients and resulted in successful seals in 91.3% of the patient population. Two deaths were reported that occurred during the PCI procedure, and seven patients underwent treatment to drain fluid collection around the heart, the FDA said in its release. A total of five post-procedure, in-hospital deaths were reported in patients with successfully sealed perforations. ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Stents Biotronik Source Type: news

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CONCLUSIONS: Our study evaluating patients with ACS or stable CAD undergoing PCI and treated with mono anti-platelet therapy with P2Y12 inhibitors due to aspirin intolerance shows a 25% incidence of POCE at one year. Further studies with adequate sample size are required to evaluate the efficacy and safety of mono anti-platelet therapy in this clinical scenario. PMID: 30895761 [PubMed - as supplied by publisher]
Source: Minerva Cardioangiologica - Category: Cardiology Tags: Minerva Cardioangiol Source Type: research
We present first-in-human treatment with bioabsorbable magnesium scaffolds for percutaneous coronary intervention in a patient with nickel allergy. We present images from angiography and optical coherence tomography at three months. We also review the current status of these novel devices.ResumoApresentamos pela primeira vez o tratamento com suportes bioabsorbíveis de magnésio na intervenção coronária percutânea complexa de doentes com alergia ao níquel. Incluímos a angiografia e as imagens da tomografia de coerência óptica efetuadas durante um perí...
Source: Revista Portuguesa de Cardiologia - Category: Cardiology Source Type: research
ConclusionsPCI did not induce substantial allergic reactions to ICM in patients with a previously diagnosed allergy. This study did not demonstrate an advantage for premedication.
Source: The Journal of Allergy and Clinical Immunology: In Practice - Category: Allergy & Immunology Source Type: research
AbstractAcupuncture anesthesia is a technique by partially or completely replacing anesthetics with acupuncture in surgery based on the traditional acupuncture analgesia mechanism. It emerged in the 1950s, went viral in the 1970s and then gradually fell into decline. In the recent years, this technique has regained attention and further research. Acupuncture anesthesia can be classified as either pure acupuncture anesthesia or acupuncture-medication combined anesthesia. To expand the application of this technique, a patient with non-ST elevation acute coronary syndrome in urgent need of percutaneous coronary intervention (...
Source: Journal of Acupuncture and Tuina Science - Category: Complementary Medicine Source Type: research
Publication date: Available online 4 July 2018Source: American Heart JournalAuthor(s): Sonali R Gnanenthiran, John Yiannikas, Harry C Lowe, David Brieger, Sandhya LimayeAbstractDual antiplatelet therapy, consisting of aspirin and a P2Y12 receptor antagonist, has been the cornerstone of management in those undergoing percutaneous coronary intervention, reducing stent thromboses and cardiovascular events. Given the pivotal role of aspirin in cardiovascular disease management, patients with aspirin hypersensitivity pose complex clinical challenges. Allergy to aspirin is reported in 1.5-2.6% of patients presenting with cardiac...
Source: American Heart Journal - Category: Cardiology Source Type: research
Conclusion PCI did not induce substantial allergic reactions to ICM in patients with a previously diagnosed allergy. This study did not demonstrate an advantage for premedication.
Source: The Journal of Allergy and Clinical Immunology: In Practice - Category: Allergy & Immunology Source Type: research
Publication date: Available online 1 November 2017 Source:The Lancet Author(s): Olivier Varenne, Stéphane Cook, Georgios Sideris, Sasko Kedev, Thomas Cuisset, Didier Carrié, Thomas Hovasse, Philippe Garot, Rami El Mahmoud, Christian Spaulding, Gérard Helft, José F Diaz Fernandez, Salvatore Brugaletta, Eduardo Pinar-Bermudez, Josepa Mauri Ferre, Philippe Commeau, Emmanuel Teiger, Kris Bogaerts, Manel Sabate, Marie-Claude Morice, Peter R Sinnaeve Background Elderly patients regularly receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of double antiplatele...
Source: The Lancet - Category: General Medicine Source Type: research
Abstract Dual antiplatelet therapy (DAT) with aspirin and clopidogrel is the standard regimen to achieve rapid platelet inhibition and prevent thrombotic events. Currently, little information is available regarding alternative antiplatelet therapy in patients with an allergy or intolerance to aspirin. Although cilostazol is already a common alternative to aspirin in clinical practice in China, its efficacy and safety remain to be determined. We retrospectively analyzed 613 Chinese patients who had undergone primary percutaneous coronary intervention (PCI). Among them, 405 patients received standard DAT (aspirin pl...
Source: Acta Pharmacologica Sinica - Category: Drugs & Pharmacology Authors: Tags: Acta Pharmacol Sin Source Type: research
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. AcelRx touts Dsuvia data for burn victims AcelRx Pharmaceuticals said today that it plans to present data from a study evaluating its Dsuvia pain reliever in patients with moderate-to-severe acute pain resulting from trauma or ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. AcelRx touts Dsuvia data for burn victims AcelRx Pharmaceuticals said today that it plans to present data from a study evaluating its Dsuvia pain reliever in patients with moderate-to-severe acute pain resulting from trauma or ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: News Well Plus 5 Source Type: news
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