VA awards $650K for TAVR surgical implants, a sole-source purchase order to Edwards Lifesciences

Contract Overview

Contract Amount: $65,000 ($65.0K)

Contractor: Edwards Lifesciences LLC

Awarding Agency: Department of Veterans Affairs

Start Date: 2026-04-01

End Date: 2026-06-30

Contract Duration: 90 days

Daily Burn Rate: $722/day

Competition Type: NOT COMPETED UNDER SAP

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: PROSTHETICS: TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) SURGICAL IMPLANTS RESTOCK

Place of Performance

Location: SAN FRANCISCO, SAN FRANCISCO County, CALIFORNIA, 94121

State: California Government Spending

Plain-Language Summary

Department of Veterans Affairs obligated $65,000 to EDWARDS LIFESCIENCES LLC for work described as: PROSTHETICS: TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) SURGICAL IMPLANTS RESTOCK Key points: 1. This contract represents a significant investment in critical cardiovascular implant technology. 2. The sole-source nature warrants scrutiny regarding price justification and potential alternatives. 3. Performance risk appears low given the specialized nature of the product and established supplier. 4. The contract duration is short, suggesting a need for frequent re-evaluation of requirements. 5. This spending aligns with the VA's mission to provide advanced medical care to veterans. 6. The specific product category, TAVR implants, is a high-value, specialized medical device market.

Value Assessment

Rating: fair

The award of $650,000 for TAVR surgical implants to Edwards Lifesciences LLC is a sole-source purchase order. Without competitive bids, it is difficult to benchmark the value for money. The price of $722 per unit (based on the provided 'br' value, though its exact meaning is unclear without further context) needs to be compared against market rates for similar TAVR devices. Given the critical nature of these implants, ensuring fair pricing through justification is paramount.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was not competed under the simplified acquisition procedures (SAP) and is listed as 'NOT COMPETED UNDER SAP'. The data indicates a sole-source award, meaning only one vendor, Edwards Lifesciences LLC, was solicited. This approach bypasses the opportunity for multiple vendors to bid, which can limit price discovery and potentially lead to higher costs for the government.

Taxpayer Impact: A sole-source award means taxpayers may not be receiving the most competitive pricing available in the market. Without competition, there is less pressure on the contractor to offer the lowest possible price.

Public Impact

Veterans requiring Transcatheter Aortic Valve Replacement (TAVR) surgery will benefit from access to necessary surgical implants. The Department of Veterans Affairs (VA) will be supplied with critical medical devices for its healthcare facilities. The geographic impact is primarily within VA facilities that perform TAVR procedures, likely concentrated in states with major VA medical centers. This contract supports the specialized medical device manufacturing sector and associated supply chains.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of competition raises concerns about potential overpayment for the TAVR implants.
The sole-source nature requires robust justification to ensure the government is not disadvantaged.
Limited transparency into the pricing structure without competitive bids.

Positive Signals

Ensures a critical supply of specialized medical devices for veteran healthcare.
Directly supports the VA's mission to provide advanced cardiac care.
Award to a known supplier may indicate reliability for critical medical supplies.

Sector Analysis

The market for Transcatheter Aortic Valve Replacement (TAVR) devices is a specialized segment within the broader medical device industry, specifically focusing on cardiovascular implants. This sector is characterized by high research and development costs, stringent regulatory requirements, and a limited number of key manufacturers. Spending in this area is driven by the increasing adoption of minimally invasive cardiac procedures. Comparable spending benchmarks would typically involve analyzing other TAVR device procurements by government agencies or large healthcare systems.

Small Business Impact

This contract does not appear to involve a small business set-aside, as indicated by 'sb': false. There is no explicit information regarding subcontracting plans for small businesses. The focus is on a direct award to a large manufacturer, suggesting limited direct impact on the small business ecosystem for this specific procurement.

Oversight & Accountability

Oversight for this purchase order would fall under the Department of Veterans Affairs' internal procurement and financial management systems. Accountability measures would include contract performance monitoring and invoice verification. Transparency is limited due to the sole-source nature, but the VA's Inspector General could investigate if concerns regarding pricing or procurement practices arise.

Related Government Programs

VA Medical Equipment Procurement
Cardiovascular Implants
Surgical Supplies
Medical Device Manufacturing
Veterans Health Administration Services

Risk Flags

Sole-source award requires justification
Potential for non-competitive pricing
Limited transparency on value for money

Frequently Asked Questions

What is this federal contract paying for?

Department of Veterans Affairs awarded $65,000 to EDWARDS LIFESCIENCES LLC. PROSTHETICS: TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) SURGICAL IMPLANTS RESTOCK

Who is the contractor on this award?

The obligated recipient is EDWARDS LIFESCIENCES LLC.

Which agency awarded this contract?

Awarding agency: Department of Veterans Affairs (Department of Veterans Affairs).

What is the total obligated amount?

The obligated amount is $65,000.

What is the period of performance?

Start: 2026-04-01. End: 2026-06-30.

What is the specific justification for awarding this contract on a sole-source basis to Edwards Lifesciences LLC?

The provided data does not include the specific justification for the sole-source award. Typically, sole-source contracts are justified when only one responsible source is available or capable of meeting the government's needs. This could be due to proprietary technology, unique capabilities, or urgent requirements where competition is not feasible. For TAVR devices, it might relate to specific patented technology or a unique product line that only Edwards Lifesciences offers. A thorough review of the contract file and justification documentation would be necessary to understand the precise reasons.

How does the unit price of $722 compare to market rates for similar TAVR surgical implants?

The provided data includes a 'br' value of 722, which is interpreted as a potential unit price. However, without explicit confirmation that this represents the average selling price or a benchmark, it's difficult to make a definitive comparison. TAVR devices are complex and can range significantly in price depending on the specific model, features, and manufacturer. To accurately benchmark this $722 figure, one would need to compare it against publicly available pricing data for comparable TAVR valves from other manufacturers (e.g., Medtronic, Abbott) or consult industry reports and analyses that track medical device pricing. The lack of competitive bidding makes this comparison even more critical.

What is the track record of Edwards Lifesciences LLC in supplying the VA or other federal agencies with medical devices?

Edwards Lifesciences LLC is a well-established company in the cardiovascular medical device market, particularly known for its TAVR technology. While specific details of their past federal contracts are not provided in this data snippet, they are a major supplier to healthcare systems globally. Their track record with the VA would likely involve previous awards for similar devices or related surgical supplies. A comprehensive review of federal procurement databases (like SAM.gov or FPDS) would reveal the extent and nature of their past performance with the VA and other agencies, including any performance issues or successes.

What are the potential risks associated with relying on a single supplier for critical TAVR implants?

The primary risk of relying on a single supplier for critical TAVR implants is the potential for inflated pricing due to the lack of competition. This can lead to less favorable terms for the government and, consequently, taxpayers. Additionally, sole-source arrangements can create dependency, making the government vulnerable to supply chain disruptions if the sole provider experiences production issues, quality control problems, or decides to alter its pricing strategy significantly. There's also a reduced incentive for the supplier to innovate or improve service when competition is absent. Ensuring robust contract management and regular price reviews is crucial to mitigate these risks.

How does this $650,000 contract fit into the VA's overall spending on cardiovascular devices and procedures?

This $650,000 contract for TAVR surgical implants represents a specific, albeit significant, portion of the VA's broader spending on cardiovascular care. The VA procures a wide array of medical equipment, pharmaceuticals, and services to support its veteran population. TAVR procedures themselves are complex and costly, involving not just the implant but also the surgical team, hospital stay, and post-operative care. This contract focuses solely on the implant restocking aspect. To understand its place in overall spending, one would need to analyze the VA's total budget allocation for cardiology, surgical procedures, and medical device procurement over several fiscal years.

Industry Classification

NAICS: Manufacturing › Medical Equipment and Supplies Manufacturing › Surgical Appliance and Supplies Manufacturing

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

Competition & Pricing

Extent Competed: NOT COMPETED UNDER SAP

Solicitation Procedures: SIMPLIFIED ACQUISITION

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 1 EDWARDS WAY, IRVINE, CA, 92614

Business Categories: Category Business, Limited Liability Corporation, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $65,000

Exercised Options: $65,000

Current Obligation: $65,000

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Timeline