The device can be advanced to a septum, e.g., towards a fossa ovalis. Stay stable . Boston Scientific 31409 Imager II Angiographic Catheter 5F Bern Selective (x) Home / Products / Boston Scientific 31409 Imager II Angiographic Catheter 5F Bern Selective (x) Disclaimer .

share: Share on Facebook Tweet on Twitter Post to Reddit. The device may further include one or more anchors, one or . . The Transseptal crossing needle device patent was assigned a Application Number # 15030437 - by the United States Patent and Trademark Office (USPTO). The device may include a flexible shaft defining a proximal portion, a distal portion, and a lumen extending therebetween to apply a vacuum to at least a portion of the tissue wall; and a tissue penetration element movably positioned within the shaft. For more information, please visit safecrossdevice.com June 12 . The new AcQCross family of catheters include versions that are length-, diameter- and tip-matched and designed to lock into the hub . . Click to learn more. Structural Heart. EP Solutions Electrophysiology Solutions Deeper diagnostic precision for coronary sinus access and beyond. The Acutus integrated TSP device is composed of (1) a steerable introducer (AcQGuide FLEX introducer, Acutus Medical, CA, USA) and (2) a transseptal crossing device (AcQCross Qx, Acutus Medical, CA, USA) that combine the vessel dilator and transseptal needle into a single component (AcQGuide MINI, Acutus Medical, CA, USA). Patent Application Number is a unique ID to identify the Transseptal crossing needle device mark in USPTO. The aortic valve is initially visible as the ICE catheter is oriented anteriorly. A transseptal puncture is critical for "left-sided" structural heart interventions. Case Presentation and Clinical Device Discussion. Clockwise rotation of the transducer brings the fossa ovalis into view along with the . A transseptal crossing needle device (32, 33, 34) for inserting an outer sheath (14) through a septum (17), comprising: an inner dilator sheath (15) received within said outer sheath and a needle (16) having a curved end portion adjacent a tip (29AB) of a tip portion (29) of the needle, said needle being received in said inner dilator sheath . (transvalvularinsertion tool), and needle.The H lee SafeSheath" (SGS splittab/e hemostatic sheaths are protected by Patent Insurance.



Carefully read instructions before use of device to help reduce potential risks and complications associated with transseptal procedures, such as air emboli and/or perforation of the aorta and left atrium (LA).

Systems, devices, and methods are provided for transseptal access of septa within a patient. Another form of percutaneous left ventricular assist device is transseptal extracorporeal membrane oxygenation. Up Next. An endoluminal punch and introducer sheath. SupraCross RF Solutions Designed for transseptal access from any approach, when the conventional solution may not be optimal. Global demand for transseptal access systems is set to experience significant growth at 9.4% CAGR through 2031, with the market value around US$ 845 Mn at present. First experience with a transseptal puncture using a novel transseptal crossing device with integrated dilator and needle First experience with a transseptal puncture using a novel transseptal crossing device with integrated dilator and needle 2022 Aug 9. doi: 10.1007/s10840-022-01329-3. An echocardiography, echocardiogram, cardiac echo or simply an echo, is an ultrasound of the heart.It is a type of medical imaging of the heart, using standard ultrasound or Doppler ultrasound.. Echocardiography has become routinely used in the diagnosis, management, and follow-up of patients with any suspected or known heart diseases.It is one of the most widely used diagnostic imaging . A medical device for crossing a tissue wall and methods of use thereof are provided. The company's first product, the SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System, provides physicians with a predictable and safe solution for crossing the atrial septum using a single device. A medical device for crossing a tissue wall and methods of use thereof are provided. The device is designed to deliver safe and efficient access to the left atrium of the heart.

Specifically designed to cross the interatrial septum at the fossa ovalis when supported by a transseptal introducer, SafeSept is a 135cm long, 0.014 inch diameter nitinol guidewire specifically designed for transseptal puncture. Online ahead of print. In recent years, the transseptal puncture approach has enabled passage of increasingly large and complex devices into the left atrium. Ve el perfil profesional de Lara Varvara en LinkedIn.

Medical (SJM) Swartz Braided Transseptal Guiding Introducer, K052644. PYLARIFY AI is artificial intelligence medical device software developed to assist with the reading and quantification of PYLARIFY scans. In general, the present invention provides a single pass transseptal crossing device, for enabling large bore access in a single pass. STEP 2: Perform 'drag-down' to locate Fossa Ovalis. Flexible needle allows precise pre-puncture steering. However, a right-side venous femoral puncture is usually preferred for the TP procedure due to the more linear trajectory to the right atrium (RA). Transseptal crossing devices are used in a range of electrophysiology and structural heart procedures, such as atrial fibrillation ablation, left atrial appendage occlusions, and transcatheter mitral valve repair. East End Medical, a private medical device company committed to improving catheter-based cardiac procedures, today announced the first commercial uses of its SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. Transseptal crossing devices are used in a range of electrophysiology and structural heart procedures, such as atrial fibrillation ablation, left atrial appendage occlusions, and transcatheter mitral valve repair. Taking an innovative approach, Protaryx aims to deliver meaningful improvements for physicians and patients. The standard transseptal equipment in our laboratory is a 71-cm Brockenbrough needle (Medtronic, Inc., Minneapolis, MN) inserted through the dilator of an 8-F, 63-cm Mullins sheath (Medtronic, Inc.). In a press release, the company said that there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices in the USA. BACKGROUND: This study aimed to evaluate the feasibility and safety of an innovative "all in one" integrated transseptal crossing device to achieve transseptal puncture (TSP). AcQCross Transseptal Access Procedure AcQCross Transseptal Access System First Transseptal Access System Cleared for Mechanical or RF Puncture STEP 1: Insert AcQCross Qx into Superior Vena Cava (SVC). The tip of the cannula is expressed distal to the tip of the dilator. The transseptal puncture system is specifically engineered to pair with Acutus' own suite of sheaths and with sheaths sold by other manufacturers. April 13, 2021 - 8:00 am. Acutus Medical Inc. has officially earned FDA approval of their AcQCross TM family of universal transseptal crossing devices. The TRANSSEPTAL CROSSING SYSTEM FOR SINGLE PASS LARGE BORE ACCESS patent was assigned a Application Number # 16896582 - by the United States Patent and Trademark Office (USPTO). Presentation. Case Study Concert Medical develops a unique and novel first-in-class wire-based CTO Crossing System. The transseptal puncture technique originated in 1957 when John Ross Jr. was passing balloons of various sizes from the right atrium through atrial septal defects to measure their size. CARLSBAD, Calif., April 13, 2021 (GLOBE NEWSWIRE) Acutus Medical, Inc. ("Acutus") (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the FDA clearance of the AcQCross family of universal transseptal crossing devices.

AFIB Earnings Power Value (EPV) as of today (October 22, 2022) is $1.76. LinkedIn es la red de negocios ms grande del mundo que ayuda a profesionales como Lara Varvara a encontrar contactos internos para recomendar candidatos a un empleo, expertos de un sector y socios comerciales. The company claimed that its AcQCross is the first and only transseptal puncture system designed to easily pair with the suite of its sheaths, along with other . The All-in-One system is designed to provide a predictable and safe solution for performing . The transseptal puncture system is specifically engineered to pair with Acutus' own suite of sheaths and with sheaths sold by other manufacturers. Presentation TVT 2019. Learn more about the first and only universal crossing device at https://lnkd.in/gy7VxYf. Procedures such as transcatheter edge-to-edge repair (MitraClip) and left atrial appendage (LAA) closure (Watchman) require precise puncture of the interatrial septum (IAS), and the presence of a prior atrial septal defect (ASD) closure device poses a challenge. The company is headquartered in Baltimore, Maryland, with engineering operations in Minneapolis, Minnesota. New Specialty Devices Transseptal crossing devices are used in a range of electrophysiology and structural heart procedures, such as atrial fibrillation ablation, left atrial appendage occlusions, and transcatheter mitral valve repair.
Transseptal crossing devices are used in a range of electrophysiology and structural heart procedures, such as atrial fibrillation ablation, left atrial appendage occlusions, and transcatheter. Tokuda et al (2018) Radiofrequency needle for transseptal puncture is associated with lower incidence of .

The Transseptal crossing needle device patent was filed with the USPTO on Friday, October 24, 2014.

Product Family Targets Over 300,000 Annual US Electrophysiology and Structural Heart Procedures .

The needle is available with a variety of curvatures to approach the atrial septum.

#AcQCross is designed to deliver an enhanced #transseptal crossing experience.

The new AcQCross family of catheters include versions that are length-, diameter- and tip-matched and designed to lock into the hub . 14th April 2021 2731 Acutus Medical has announced US Food and Drug Administration (FDA) clearance of the AcQCross family of universal transseptal crossing devices. We aimed to report the preliminary experience with the Myval balloon-expandable device in this setting. "This is the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus' own suite of sheaths and with sheaths sold by other manufacturers," the . The SafeSheath CSG and CSG Worley Introducer Systems includes sheath, guiding dilator, vessel dilator, guide wire, r.V.I. In a press release, the company said that there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices in the USA. European Patent EP1360972. Table 5.3 PREDICATE DEVICE Predicate Device Manufacturer FDA 510(k) Swartz Braided Transseptal Guiding Sanchez et al (2020) A Cost-Effectiveness Analysis Comparing a Conventional Mechanical Needle to a Radiofrequency Device for Transseptal Punctures. Methods: Sixty-four drug-refractory AF patients with ASO who . TVT 2019. The TSX Transseptal Delivery System with the TSX Fixed Sheath and TSX Transseptal Needle designed to facilitate tissue crossing with excellent torque, an atraumatic tip and radiopacity for better visualization. The Baylis platforms offer advanced transseptal puncture. The global standard in transseptal access, with a full suite of devices to take you further. Presenter: Akhil Narang. Traditional tools remain effective in creating and dilating the initial puncture, with an acceptable safety profile. Acutus Medical, an arrhythmia management company, has received the US Food and Drug Administration (FDA) approval for its AcQCross family of universal transseptal crossing devices. The new and expanded family of AcQCross catheters include versions that are length-, diameter-, and tip-matched and designed to lock into the hub of sheaths now used in the vast majority of left. A septostomy device 10 with a cutting structure or means 140 and tissue capture mechanisms 240, 250 is disclosed, along with a medical procedure for using the device. Delivery of the transseptal cannula (22) to a heart tissue includes a low profile coaxial balloon catheter (28) comprising a tube body including an inner side member (64) and an outer side member (66) creating an inflation channel (68) between the inner side and outer side members (64, 66), a hub (56) coupled to the proximal portion of the tube . December 10, 2020 By Danielle Kirsh. This is the only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus' own suite of sheaths and with sheaths sold by other manufacturers. The VersaCross RF Transseptal Solution is the world's first . The system includes an insulated cannula with a conductive tip positionable through the dilator of a large bore sheath. Carlsbad, Calif.-based Acutus touts the AcQCross system as the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus' suite of sheaths, as well as with sheaths sold by other manufacturers, according to a news release. with .014-inch diameter that has a sharp and floppy "J tip" that assumes a straight orientation while inside the transseptal needle, allowing crossing the septum, but immediately prolapses, assuming a J shape, upon entry into . Realizing that this was an easy access route to the left atrium, he subsequently developed a needle to create an access path through intact septa [12]. Publication Highlights. A posterior transseptal crossing facilitates device delivery into the anteriorly located LAA. Over the lifetime, 1449 publication(s) have been published in the journal receiving 6203 citation(s). Stabilizing loop offers enhance puncture dynamics. Tools for transseptal catheterization require a needle or needle-based technology for crossing the interatrial septal tissue and a support device (e.g., sheaths) to enable the needle to reach the appropriate location and provide support for the crossing. The needle tip portion comprises an angled transverse end surface terminating at said tip and . Explore 72 research articles published in the Journal Journal of Arrhythmia in the year 2013. This angle of crossing is often favorable to facilitate: (1) left ventricular access for ventricular tachycardia ablation; (2) mapping the mitral annulus during accessory pathway ablation; or (3) placement of a LAA closure device.

The US Food and Drug Administration has cleared the AcQCross family of universal transseptal crossing devices, Acutus Medical announced today. Guidewire remains retained in dilator. Acutus Medical Announces FDA Clearance of AcQCross, a Full Suite of Universal Transseptal Crossing Devices. The journal publishes majorly in the area(s): Catheter ablation & Atrial fibrillation. Other Emerging Dedicated Transseptal Crossing Technologies (510-Kardiac and East End Medical) Presenter: Scott Lim. Other USA and Worldwide Patents pending. Instead of applying positive pressure to "tent" the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe . Find Out More about the Report Coverage Some contemporary tools employ radiofrequency to assist with crossing the septum. | June 10, 2022 East End Medical was founded to improve catheter-based cardiac procedures. The endoluminal punch includes a secondary blade, or fin blade affixed to the distal end of the endoluminal punch to increase the size of an incision. Background: An atrial septal occluder (ASO) represents a major obstacle to the widespread adoption of atrial fibrillation (AF) catheter ablation in patients with prior atrial septal defect (ASD) closure. Background: The vast majority of transcatheter valve-in-valve (ViV) mitral procedures have been reported with the SAPIEN family. This innovative transseptal puncture system is the first of its kind to universally pair and mate seamlessly with Acutus Medical's family of sheaths in addition to sheaths sold by other approved manufacturers 1. Protaryx Medical is a medical device company committed to reimagining access to the left atrium for transcatheter cardiac procedures. It includes the company's AcQCross Qx with either the AcQGuide Mini or steerable AcQGuide Flex introducer sheath . June 12, 2019. As per Persistence Market Research's projections, transseptal access sheath hold a substantial share of around 86% in the overall market. REGISTER for free or LOG IN to view this content. The SafeSept is the first significant advance in left atrial access since the Brockenbrough needle. The transseptal puncture system is specifically engineered to pair with Acutus' own suite of sheaths and with sheaths sold by other manufacturers. Direct Visualization Devices, Systems, and Methods for Transseptal Crossing 20170135559 - 15349813 - USPTO Application Nov 11, 2016 - Publication May 18, 2017 The device may include a flexible shaft defining a proximal portion, a distal portion, and a lumen extending therebetween to apply a vacuum to at least a portion of the tissue wall and a tissue penetration element movably positioned within the shaft. The first and only transseptal access system on the market cleared for both mechanical and radiofrequency (RF) crossing, the AcQCross system simplifies transseptal crossing for electrophysiologists or interventional cardiologists to improve workflow, add procedure efficiencies, and help alleviate complexity during left heart procedures. STEP-BY-STEP TRANSSEPTAL PUNCTURE PROCEDURE Step 1: Femoral Puncture Both groins should be prepared because invasive arterial monitoring might be needed should any complication occur.

Methods: Multicenter retrospective study of high-risk surgical patients with mitral bioprosthesis degeneration undergoing transcatheter ViV implantation with Myval . Transseptal crossing devices are used in a range of electrophysiology and structural heart procedures, such as atrial fibrillation ablation, left atrial appendage occlusions, and transcatheter mitral valve repair. Request PDF | First experience with a transseptal puncture using a novel transseptal crossing device with integrated dilator and needle | Background This study aimed to evaluate the feasibility . Trade/Device Name: Guider Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II . USA Patent 7,462, 184. The system 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue. Aims: The aim of this study was to describe the "sequential technique" of transseptal puncture (TSP) in AF patients with ASO. In depth view into Acutus Medical Earnings Power Value (EPV) explanation, calculation, April 14, 2021 The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal transseptal crossing devices. In a press release, the company said that there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices in the USA. In the third row, the transseptal needle has been rotated further in a clockwise manner; now the needle is directed . Guidewire NRG RF Transseptal Kit Take Control of Your Crossing. . Precautions: US federal law restricts this device to sale by or on the order of a physician. In a transseptal crossing needle device for inserting an outer sheath through a septum, an inner dilator sheath is received within the outer sheath and a needle having a curved end portion adjacent a tip of a tip portion of the needle is provided, the needle being received in the inner dilator sheath. A medical device for crossing a tissue wall and methods of use thereof are provided. Even for skilled operators, the procedure is tec The device may include a flexible shaft defining a proximal portion, a distal portion, and a lumen extending therebetween to apply a vacuum to at least a portion of the tissue wall; and a tissue penetration element movably positioned within the shaft. Video 1: Real-time anterior to posterior intracardiac echocardiography (ICE) sweep. Patent Application Number is a unique ID to identify the TRANSSEPTAL CROSSING SYSTEM FOR SINGLE PASS LARGE BORE ACCESS mark in USPTO. CARLSBAD, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. ("Acutus") (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed. Authors The transseptal puncture system is specifically engineered to pair with Acutus' own suite of sheaths and with sheaths sold by other manufacturers. Acutus Medical today said it received CE mark approval for its transseptal crossing products. The TRANSSEPTAL CROSSING SYSTEM FOR SINGLE PASS LARGE BORE ACCESS patent was filed . The technology automatically analyzes a PSMA PET/CT image to segment anatomical regions - 51 bones and 12 soft tissue organs. CARLSBAD, Calif., April 13, 2021 -- Acutus Medical, Inc. , an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the FDA. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies.

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METHODS: Twenty patients (10 males, mean age 65.65 9.25 years), indicated to supraventricular left side tachyarrhythmia ablation, underwent TSP using a new-generation integrated crossing device, and a control cohort . A medical device for crossing a tissue wall and methods of use thereof are provided. Imaging. Braided steel core imparts excellent torqueability Dual distal holes Radiopaque sheath and dilator enable in situ visualization The device may further include one or more anchors, one or . The device may include a flexible shaft defining a proximal portion, a distal portion, and a lumen.