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The PASCAL Precision System

For degenerative mitral regurgitation

PASCAL Precision System background image
PASCAL Precision System background image
PASCAL Precision System background image

Meet the PASCAL
Precision System

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

Meet the PASCAL Precision System Image
Meet the PASCAL Precision System Image
Meet the PASCAL Precision System Image

Discover the difference with the PASCAL implants

Designed for patient-focused care

PASCAL implant

Designed to reduce leaflet stress and increase open orifice area enabling low gradients

PASCAL Ace implant

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

The PASCAL Ace image
The PASCAL Ace image
The PASCAL Ace image

The PASCAL Ace and PASCAL implants offer different designs with the same functionality.

Features

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

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Features Image
Features Image

Predictable implant release

Deploy the implant with confidence

predictable implant release
predictable implant release
predictable implant release

The MR reduction you see before implant release is the result you can achieve for your patient after release

predictable implant release
predictable implant release
predictable implant release
Change in pre and post-delivery MR
Change in pre and post-delivery MR
Change in pre and post-delivery MR

N=141 patients (n=59 DMR patients) were included in a retrospective multi-center observational study1 conducted at three sites in Germany to assess change in residual MR pre- and post-delivery of the PASCAL device (PASCAL and PASCAL Ace implants). Change in pre- and post-delivery MR was evaluated from intraprocedural echo in a blinded assessment at a central core lab, and classified into either improved, unchanged, or deteriorated.+

Of the DMR subset of the study cohort* (n=59 patients):

  • 98% had unchanged or improved MR result post-delivery
  • 25% had improved MR result post-delivery
Change in pre and post-delivery MR
Change in pre and post-delivery MR
Change in pre and post-delivery MR

1 Mahabadi, A. (2024, May 14-17). Predictable implant release: evidence, and case-based discussion [Conference presentation]. Euro PCR 2024, Paris, France.

+ Deteriorated defined as: reoccurrence of MR due to new jet, increase of residual MR, and/or return of MR

* The PASCAL Precision System is approved for DMR only in the US

Overview of the PASCAL Precision system

Advanced catheter technologies facilitate smooth navigation and implant deployment

Overview of the PASCAL Precision system image
Overview of the PASCAL Precision system image
Overview of the PASCAL Precision system image

Watch the PASCAL Precision system in action


Clinical evidence

CLASP IID: The first randomized controlled trial to directly compare two contemporary TEER therapies

CLASP: An international, multi-center prospective safety and clinical outcomes study

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Features Image
Features Image

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.

1. Zahr F, Smith RL, Gillam LD, et.al. One-year Outcomes from the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. J Am Coll Cardiol Intv 2023; Oct 26; [Epub Ahead of Print]; DOI: https://doi.org/10.1016/j.jcin.2023.10.002

The PASCAL Ace image
The PASCAL Ace image
The PASCAL Ace image

CLASP IID is a 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*

2. Szerlip M, Spargias KS, Makkar R, Kar S, Kipperman RM, O’Neill WW, et al. 2-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. JACC Cardiovasc Interv. 2021 Jul 26;14:1538-1548. Epub 2021 May 18. Erratum in JACC Cardiovasc Interv. 2022 Jul 11;15:1395. 

The PASCAL Ace image
The PASCAL Ace image
The PASCAL Ace image

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

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Reimbursement Information: Resources and tools
Learn about coding, coverage, and more.

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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.

Edwards Reusable Accessories

Indications: The Edwards reusable platform, reusable plate, and reusable cradle are reusable, non‐sterile accessories indicated for use with compatible Edwards transcatheter cardiac therapies. The reusable platform and reusable plate are non‐patient contacting and are intended to aid the positioning and stabilization of delivery systems during intra‐cardiac procedures.

Contraindications: There are no specific contraindications for these accessories.

Warnings: There are no warnings specific to these accessories.

Precautions: The reusable platform, reusable plate, and reusable cradle are NON‐STERILE; introduction of the reusable platform, reusable plate, and reusable cradle into the sterile field may result in infection. Prior to use, cleaning must be performed according to the Edwards Reusable Accessories Instructions for Use.  Do not use metallic brushes, scrub pads, or other abrasive cleaning aids when cleaning the devices. They can cause permanent device damage.

Potential Adverse Events: There are no known potential adverse events specific to the Edwards reusable platform, reusable plate, or reusable cradle.

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 more information, see Edwards.com/PASCAL