Meet the PASCAL Precision System

Introducing the latest advancement from Edwards Lifesciences in transcatheter mitral therapies: The PASCAL Precision system

PASCAL devices

Discover the difference with the PASCAL implants

Designed for patient-focused care: 2 implant sizes allow you to adjust to your procedural needs

 

PASCAL Implant

Designed to minimize stress on leaflets and reduce risk of leaflet tears

 

PASCAL Ace Implant

Features a narrower design profile to help you optimize your treatment of degenerative mitral regurgitation

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The PASCAL Ace and PASCAL implants offer distinct designs and functionality.

Features

Treat your patients with degenerative mitral regurgitation with the latest transcatheter innovation from Edwards Lifesciences

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Versatile implant configuration to navigate even challenging anatomies

Adapt to specific procedural and anatomical needs

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A wide range of paddle mobility and full elongation capabilities helps you maneuver, reconfigure, and retrieve the implant prior to release

Atraumatic clasp and closure help you preserve leaflet integrity

Enhance leaflet capture with atraumatic reclasp capabilities

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Super-elastic nitinol construction enables passive implant closure and dynamic implant flexing

Designed for precise placement with accurate, intuitive control

Advanced catheter and handle design facilitates smooth navigation and implant deployment

Responsive catheter design with optimized torque transfer to facilitate implant placement

  • Clasp sliders allow for both independent and simultaneous clasping, while the implant actuation knob provides full implant configuration control
  • Hydrophilic coating and inter-catheter clearance for reduced friction and more responsiveness
  • Laser-cut hypotube technology provides stability and balanced catheter flexibility
  • Handle controls engineered for intuitive manipulation, allowing the user to focus on treating the patient

Overview of the PASCAL Precision system

Advanced design facilitates smooth navigation and implant deployment

Watch the PASCAL Precision system in action

Clinical evidence

From large, randomized trials with outcomes in early experience comparable to existing transcatheter edge-to-edge repair (TEER) technologies

CLASP IID logos Clasp Trial logo

CLASP IID trial

The objective of this prospective, multicenter, randomized, controlled pivotal trial is to evaluate safety and effectiveness in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

MR Reduction

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CEC-adjudicated Major Adverse Events at 30 Days

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New York Heart Association Functional Class at 6 Months

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1. Results from the CLASP IID randomized, controlled pivotal trial for degenerative mitral regurgitation in prohibitive surgical risk patients. NCT03706833

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CLASP IID is a landmark clinical trial from Edwards Lifesciences, reinforcing TEER as safe and effective for the treatment of patients with degenerative mitral regurgitation.

CLASP trial

Demonstrated sustained MR reduction and functional improvement at 2 years2*

DMR

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Survival

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Freedom from HF Rehospitalization

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New York Heart Association Functional Class

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2. Szerlip M, et al. 2-Year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1538-1548.
*Represents DMR patients from the CLASP trial data.

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Edwards Lifesciences is invested in building a robust body of clinical evidence, including 5 transcatheter mitral and tricuspid pivotal studies.

Reimbursement Information: Resources and tools
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Important safety information

Important safety information

Edwards PASCAL Precision Transcatheter Valve Repair System

Indications: The PASCAL Precision transcatheter valve repair system (the PASCAL Precision system) is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR.

Contraindications: The PASCAL Precision system is contraindicated in patients with the following conditions: patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; untreatable hypersensitivity or contraindication to nitinol alloys (nickel and titanium) or contrast media; active endocarditis of the mitral valve; rheumatic etiology for mitral regurgitation; evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.

Warnings: The devices are designed, intended, and distributed for single use only. There are no data to support the sterility, non-pyrogenicity, and functionality of the devices after reprocessing. Devices should be handled using standard sterile technique to prevent infection. Do not expose any of the devices to any solutions, chemicals, etc., except for the sterile physiological and/or heparinized saline solution. Irreparable damage to the device, which may not be apparent under visual inspection, may result. Do not use any of the devices in the presence of combustible or flammable gases, anesthetics, or cleaners/disinfectants. Do not use the devices if the expiration date has elapsed. Do not use if the packaging seal is broken or if the packaging is damaged for sterile devices. Do not use if any of the devices were dropped, damaged or mishandled in any way. Standard flushing and de-airing technique should be used during preparation and throughout procedure to prevent air embolism.

As with any implanted medical device, there is a potential for an adverse immunological response. Serious adverse events, sometimes leading to surgical intervention and/or death, may be associated with the use of this system ("Potential Adverse Events"). A full explanation of the benefits and risks should be given to each prospective patient before use. Careful and continuous medical follow-up is advised so that implant-related complications can be diagnosed and properly managed. Anticoagulation therapy must be determined by the physician per institutional guidelines.

Precautions: Prior to use, patient selection should be performed by a heart team to assess patient risk and anatomical suitability. After use, short-term anticoagulation therapy may be necessary after valve repair with the PASCAL Precision system. Prescribe anticoagulation and other medical therapy per institutional guidelines.

Potential Adverse Events: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the PASCAL Precision system: death; abnormal lab values; allergic reaction to anesthetic, contrast, heparin, Nitinol; anemia or decreased hemoglobin (may require transfusion); aneurysm or pseudoaneurysm; angina or chest pain; anaphylactic shock; arrhythmias – atrial (i.e. atrial fibrillation, Supraventricular tachycardia); arrhythmias – ventricular (i.e. ventricular tachycardia, ventricular fibrillation); arterio-venous fistula; atrial septal injury requiring intervention; bleeding; cardiac arrest; cardiac failure; cardiac injury, including perforation; cardiac tamponade/pericardial effusion; cardiogenic shock; chordal entanglement or rupture that may require intervention; coagulopathy, coagulation disorder, bleeding diathesis; conduction system injury which may require permanent pacemaker; deep vein thrombosis (DVT); deterioration of native valve (e.g., leaflet tearing, retraction, thickening); dislodgement of previously deployed implant; dyspnea; edema; electrolyte imbalance; emboli/embolization including air, particulate, calcific material, or thrombus; endocarditis; esophageal irritation; esophageal perforation or stricture; exercise intolerance or weakness; failure to retrieve any PASCAL Precision system components; fever; gastrointestinal bleeding or infarct; heart failure; hematoma; hemodynamic compromise; hemolysis; hemorrhage requiring transfusion or intervention; hypertension; hypotension; implant deterioration (wear, tear, fracture, or other); implant embolization; implant malposition or failure to deliver to intended site; implant migration; implant thrombosis; infection; inflammation; LVOT obstruction; mesenteric ischemia; multi-system organ failure; myocardial infarction; native valve injury; native valve stenosis; nausea and/or vomiting; need for open surgery (conversion, emergent or nonemergent reoperation, explant), nerve injury neurological symptoms, including dyskinesia, without diagnosis of TIA or stroke; non-neurological thromboembolic events; pain; papillary muscle damage; paralysis; PASCAL Precision system component(s) embolization; peripheral ischemia; permanent disability; pleural effusion; pulmonary edema; pulmonary embolism; reaction to anti-platelet or anticoagulation agents; renal failure; renal insufficiency; respiratory compromise, respiratory failure, atelectasis, pneumonia – may require prolonged ventilation; retroperitoneal bleed; septal damage or perforation; septicemia, sepsis; skin burn, injury or tissue changes due to exposure to ionizing radiation; single leaflet device attachment (SLDA); stroke; syncope; transient ischemic attack (TIA); urinary tract infection; and/or bleeding; valvular regurgitation; vascular injury or trauma, including dissection or occlusion; vessel spasm; ventricular wall damage or perforation; worsening native valve regurgitation / valvular insufficiency; worsening of heart failure; wound dehiscence, delayed or incomplete healing.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See Instructions for Use for full prescribing information.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

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