WATCHMAN FLX™ Left Atrial Appendage Closure Device
Built on the most studied and implanted LAAC device in the world, WATCHMAN FLX is a generation ahead for safety and simplicity and expands the treatable patient population.
The WATCHMAN FLX LAAC Device performs with advanced procedural safety and simplicity in the widest range of patient anatomies, making it the most implanted FDA approved LAAC device.
The most studied LAAC device in the world
Advancing the standard of care with proven, safe, and trusted patient outcomes.
20 yrs
Of innovation and experience
700+
LAAC programs established
150k+
Patients treated
Safety. Simplicity. Seal.
PINNACLE FLX, the WATCHMAN FLX US IDE Trial, demonstrated a 0.5% major adverse event rate, 100% effective LAA closure at 12 months, and a low 1.7% annualized ischemic stroke or systemic embolism rate at 24 months. 4, 5
0.5%
Ischemic Stroke (2 of 400)4
0%
All-cause death4
0%
Pericardial effusions requiring open cardiac surgery4
0%
Device embolization4
0.5%
Major Adverse Event Rate 6*
100%
Rate of effective LAA closure at 12 months**
99%
Procedural success (395/400)6
35%
Shorter procedure time than Legacy WATCHMAN 6,7
*Occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention
**LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE
Over one in three people with AFib feel trapped between the fear of having a stroke and fear of the risks associated with blood thinners. In fact, more than 4 in 5 people with AFib taking a blood thinner (83%) say they would be willing to try a different treatment to help reduce their risk of stroke.1
WATCHMAN FLX LAAC device effectively reduces the risk of stroke—without the risk of bleeding that can come with the long-term use of blood thinners.2
This makes LAAC therapy an important option for people with a history or risk of serious bleeding on blood thinners.
Direct-to-patient LAAC program resources
Support patients along their entire journey.
The direct-to-patient campaigns are uniquely designed to find, activate, and nurture potential candidates for the procedure. This innovative, multi-channel campaign delivers its message through TV advertisements and digital marketing programs encouraging patients to complete an online questionnaire to see if the procedure may be right for them. Since 2019, the campaign has reached more than 90% of AFib patients in the U.S.
Find
TV, social media, and digital marketing delivers compelling message.
Activate
Online survey assesses eligibility and prompts internal conversation with physician.
Nurture
Dedicated patient support and education programs build confidence.
100,000+ qualified patients have completed the eligibility survey on WATCHMAN.com.3
WATCHMAN Calibration Program (WCP)
With the WATCHMAN Calibration Program, you have a trusted partner to help enhance the patient experience and leverage our expertise to help increase patient volumes and eliminate barriers to productivity.
The WATCHMAN Calibration Program focuses on these key objectives:
- Discovery: Interviews with key program stakeholders to understand the current day-to-day process
- Strategic Planning: We create an Action Plan with recommended solutions based on real-time feedback and data.
- Application: You decide which solutions to prioritize within your program and we provide ongoing support to help you succeed.
Improve referral management
- Analyze and grow referrals using data-driven insights
- Drive therapy awareness through education and activation
- Identify and manage patients using technology opportunities
Increase program efficiency
- Coordinate care between the hospital and clinic
- Improve operations in the cardiovascular service line and the cath lab
- Discuss and refine hospital marketing processes
WATCHMAN Reimbursement
National coverage for a broad range of patients including:
- Weighted average increase for LAAC (DRG 273-274) in 2023 is 6.9% or an additional $1540
- Broad commercial payer coverage with national payers covering over 99% of commercially covered lives
- WATCHMAN CMS reimbursement has increased 89% over the last 8 years
- Since 2015, CMS reimbursement has increased $11,003 nationally
WATCHMAN health economics and market access support
A dedicated team of WATCHMAN-focused health economics professionals help you understand the economics of your LAAC program at various levels through:
Program economic overview
Using publicly available data, our team identifies current year reimbursement, historic cost detail, including LOS, and DRG mix while comparing hospital specific benchmarks to national, state, and core-base statistical areas (CBSA)
Program economic deep-dive
Using customer-specific ICD-10-CM/PCS data, our team analyzes coding, charges, and direct costs of the LAAC program to identify opportunities to improve revenue cycle management, calculate contribution margin, and compare hospital specific performance year over year by fiscal or calendar year.
Resources and tools: WATCHMAN download center
- Coding and claims for WATCHMAN procedures
- National coverage determination
- Resources supporting prior authorization, appeals, and beyond
References:
1. WatchUsNow.com. The Harris Poll online survey. Boston Scientific. SH-574213-AA https://www.watchusnow.com/?page=d75be9d4-ba36-456c-a72d-dc3df07892da. Accessed March 28, 2019
2. PINNACLE FLX: Final Report of 24-Month Results, Late Breaking Presentation at TVT 2021 by Dr. Saibal Kar
3. BSC Data on file
4. Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021
5. PINNACLE FLX: Final Report of 24-Month Results, Late Breaking Presentation at TVT 2021 by Dr. Saibal Kar.
6. Kar, PINNACLE FLX; 12 Month Outcomes, CIRCULATION, 2021
7. Reddy VY, et al. JACC 2017; 70(24): 2964-2975