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Confluent Medical Technologies | Company Profile

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COMPANY PROFILE / FUNCTIONAL MATERIALS

Confluent Medical Technologies
— An unlisted contract manufacturer that supplies nitinol tube and wire, and the parts made from them, to medical-device makers

Confluent Medical Technologies (Confluent) is a U.S.-based contract manufacturer that makes nitinol (nickel-titanium) material, as tube and wire, and parts laser-processed from it for medical-device makers. It also makes catheters, balloons, polymer tubing and implantable textiles, but this profile is limited to nitinol, the functional-materials part. The company is unlisted and does not publish its sales. From its official site and press releases and from the U.S. SEC filing of its partner ATI, we set out what is known and what is not. We give no medical advice.

Basis: Confluent’s official site (About Us, product pages, press releases) and its partner ATI Inc.’s U.S. SEC filing (Form ARS) / Last updated October 2026

What this article covers
  1. Confluent at a glance, and its place in functional materials
  2. Logo and naming
  3. Where the company sits in functional materials
  4. Company scale
  5. Resources committed to functional materials
  6. Track record
  7. Plans
  8. What the company appears to be aiming for
  9. Partnership map
  10. Technologies and products
  11. Risks
  12. Glossary / References / Claim-to-source audit

1. Confluent at a glance, and its place in functional materials

LEGAL NAMEConfluent Medical Technologies, Inc.Formerly Nitinol Devices & Components (NDC); renamed in 2016
LOCATIONUnited States (8 sites)Press releases are datelined Scottsdale, Arizona
LISTING AND OWNERSHIPUnlisted
TPG Capital holds a majority
Announced January 2022; Ampersand Capital keeps a substantial minority stake
TYPE IN THIS FIELDComponents & devices (primary)
Materials (secondary)
Contract manufacture of nitinol tube, wire and parts
CENTRAL MATERIAL AND FUNCTIONNitinol
Superelasticity and shape memory
For catheter-based and other medical devices
EMPLOYEESMore than 2,000About Us. Sites in the U.S., Costa Rica and India
KEY SITESFremont, California
Costa Rica, India and others
Tube at Fremont; wire at a dedicated plant in India (2026)
SALESNot disclosedNot stated on the official site
The one point to grasp first

Confluent is neither a “materials maker” nor a “medical-device maker.” It is a contract manufacturer that makes materials and parts at the request of medical-device makers (OEMs) Sourced. In nitinol it handles both tube and wire as material and parts that are laser-cut, heat-treated and polished, and it has a partnership under which it supplies material from ATI, which does the melting Sourced. In this series it therefore sits between a materials maker such as Furukawa Techno Material and the makers of finished parts. This profile explains the material and the company; it is not advice about any specific medical device or treatment.

2. Logo and naming

A note on naming: the company is Confluent Medical Technologies (Confluent for short). It was renamed in 2016 from Nitinol Devices & Components (NDC). NDC was acquired by Johnson & Johnson in 1999 and spun off in 2008, according to the company’s history. ATI, the U.S. specialty-alloy company that does the nitinol melting, appears in this profile and is a separate legal entity.

Official site: https://confluentmedical.com/

3. Where the company sits in functional materials

Four types of companies in functional materials Same “materials company,” different strengths and customers: raw materials, parts, surfaces, new approaches Materials & raw materials Make the materials MP Materials / Shin-Etsu Croda / Aspen Aerogels Resources and scale Tied to prices and rules Components & devices Turn function into parts Murata / TDK Kyocera / Gentex Design, quality, clients Demand and approvals Coatings & surfaces Add function to surfaces PPG / AkzoNobel and others Formulation and coating Needs per-use approval Startups & new approaches Commercialize new ideas Niron / Metalenz Lumotive / Phononic Own tech, room to grow Scale-up and funding risk Confluent is mainly a components maker: it makes nitinol tube and wire, then forms them into parts A contract manufacturer for medical-device makers, supplying nitinol material and parts end to end
Fig. 1 Four types of companies in functional materials, and where Confluent sits. The grouping is ours, and the company names are examples from this series Our calculation. We treat Confluent as a contract manufacturer that holds both nitinol tube and wire (material) and laser-processed parts.

Confluent is mainly a components-and-devices maker (contract manufacturer), but because it also makes nitinol tube and wire, it has a foot in materials as well Our calculation. The company describes itself as a medical-device and materials-science contract manufacturer and promotes a “vertically integrated, U.S.-based nitinol supply chain” Sourced. In the field that our explainer “Shape memory alloys” describes from the principles side, Confluent takes on everything from material to part.

4. Company scale

Because the company is unlisted, no sales or profit figures are published. The figures it does publish are below Sourced.

ItemDetailType of source
EmployeesMore than 2,000 (About Us). The home page shows more than 200 engineersCompany statement
SitesEight sites in the U.S., Costa Rica and India (About Us). A press-release list names Fremont and Orange County in California; Warwick, Rhode Island; Windham, Maine; Austin, Texas; Chattanooga, Tennessee; San Jose, Costa Rica (the plant is in Alajuela); and Hyderabad, IndiaCompany statement
Manufacturing areaOver 400,000 sq. ft. (home page)Company statement
OwnershipTPG Capital holds a majority (announced January 2022). Ampersand Capital Partners keeps a substantial minority stake. A September 2024 press release also refers to TPG’s 2022 investmentCompany press releases
Sales and profitNot disclosed—
QualityISO 13485 certified, FDA registered (company statement), MDSAP certificates (company statement), ISO 8 cleanroomCompany statement
A caution

The company describes itself as the “highest-volume supplier of nitinol materials for the medical device industry,” a “market leader” and the maker of the “world’s purest nitinol” Sourced. These are the company’s own words, and no statistics or test conditions are given for the rank or the purity. We do not adopt them Not yet confirmed. A company press release also says that nitinol demand is growing at an 18% compound annual rate, but gives no source; because it resembles a market-research estimate, we do not adopt that figure.

5. Resources committed to functional materials

Type of resourceWhat the sources showStatus
PeopleMore than 2,000 employees and more than 200 engineers (home page). Tom Testa became chief operating officer (COO) effective 29 April 2026. A one-day nitinol training course, “Nitinol University,” is held twice a year in FremontSourced
Money (investment)More than US$50 million invested over several years in ATI’s nitinol melt and conversion infrastructure (announced January 2024). A 66,000 sq. ft. building added at the Costa Rica site (August 2022). A dedicated nitinol wire plant in India of 26,000 sq. ft. (announced May 2026). Total capital expenditure and R&D are not disclosedSourced; totals not disclosed
Investments, acquisitions, joint venturesAcquisitions: Interface Catheters (2015), ETE Medical (2017, biomedical textiles), Corpus Medical (2018) and Tube Hollows International (2019, to vertically integrate nitinol tube). Investment: capital for ATI (2024). Investment in Confluent: TPG (2022). Johnson & Johnson acquired its predecessor NDC in 1999 and spun it off in 2008Sourced
Universities, research institutes, public fundingNot confirmed. We found no university joint research or public grants (“Nitinol University” is training run by the company, not joint research)Not confirmed

Status of main products and facilities

ProductPlant / facilityScaleStageDate and source
Nitinol tubeNitinol Tubing Center of Excellence, Fremont, CaliforniaOuter diameter 0.5 to 10 mm (manufacturer’s stated values). Output not disclosedOperatingReferences 3, 5 https://confluentmedical.com/capabilities/nitinol-material/ https://confluentmedical.com/confluent-medical-technologies-announces-nitinol-wire-center-of-excellence/
Nitinol wireDedicated plant in Hyderabad, India; described as ISO 13485 compliant26,000 sq. ft. The company says wire output doubles. Wire diameters of 0.004 to 0.100 inch with a 4-week lead time (manufacturer’s stated values)Opened (announced May 2026)Reference 5 https://confluentmedical.com/confluent-medical-technologies-announces-nitinol-wire-center-of-excellence/
Nitinol parts and cathetersPlant in Alajuela, Costa Rica66,000 sq. ft. added. Capacity not disclosedExpansion opened (August 2022)Reference 9 https://confluentmedical.com/confluent-medical-technologies-announces-grand-opening-of-costa-rica-expansion/
Nitinol melting (ATI’s side)ATI’s facilities (location not confirmed in this profile)ATI states it expects to more than triple its nitinol production by fiscal 2027Plan or under construction (Not yet confirmed)References 6, 7 https://confluentmedical.com/confluent-announces-significant-investment-in-ati-nitinol-melt-expansion/ https://www.sec.gov/Archives/edgar/data/1018963/000119312524080441/d927640dars.pdf

6. Track record

WhenWhat happenedWhy it matters
1991Nitinol Devices & Components (NDC) foundedAn early maker of medical nitinol parts
1999, 2008Acquired by Johnson & Johnson (1999), later spun off (2008)Independence after a stint under a large medical-device group
2010Began nitinol manufacturing in Costa RicaThe start of its overseas base
2015 to 2018Acquired Interface Catheters, ETE Medical and Corpus Medical. Renamed Confluent in 2016Broadened from nitinol parts into catheters, balloons and textiles
2019Acquired Tube Hollows InternationalTo vertically integrate the nitinol tube supply chain (company’s explanation)
2020 to 2023Catheter development center in Austin, Texas (2020), polymer tubing center in Chattanooga, Tennessee (2021), entry into Hyderabad, India (2023)Expanded beyond nitinol and added wire capacity
January 2022TPG Capital announced a majority investmentA change in ownership structure
January 2024Announced an investment of more than US$50 million in ATI’s nitinol melt expansion and became ATI’s “fulfillment partner” for medical nitinolA move to secure melt supply
May 2026Announced the “Nitinol Wire Center of Excellence” in Hyderabad. Fremont now concentrates on tubeSeparation of wire and tube production sites

7. Plans

ATI MELT EXPANSIONMore than triple
by fiscal 2027 (ATI’s expectation)
Confluent invests more than US$50 million over several years
WIRE OUTPUTDoubled at the dedicated plant in IndiaAnnounced May 2026; later output not disclosed
LEAD TIME (STATED)Wire: 4 weeksIndia plant, 0.004 to 0.100 inch. A tube lead time could not be confirmed
SALES TARGETS AND NEW PLANTSNone statedNo numerical targets published

All of these are plans of the company or its partner, or the company’s stated values, not achieved results Not yet confirmed. The company stresses “continued investment in a resilient, vertically integrated nitinol supply chain” and suggests that growth in medical-device markets will push demand up (we do not adopt the growth rate, because no source is given).

What could not be confirmed

None of the following appears in the primary sources we reviewed Not yet confirmed.

Sales and profit / nitinol production capacity (tube or wire) / customer names (likely undisclosed under contract) / total capital expenditure and R&D / the location and latest schedule of ATI’s facilities / university joint research.

8. What the company appears to be aiming for

This section includes points the company does not state directly. They are inferences from the primary sources, shown with their basis.

What can be readPrimary-source basisStatus
It puts stable nitinol supply at the center of the value it offers customersThe acquisition of a tube maker (2019), the investment in ATI (2024) and the dedicated wire plant (2026) are all described in terms of a “vertically integrated supply chain”Sourced
It chose to use ATI’s facilities rather than own a melting operationThe investment goes into ATI’s facilities, and nothing says Confluent will build melting equipment of its ownInference
It aims to scale by separating wire and tube sitesThe company says it moves wire to a dedicated plant in India and lets Fremont concentrate on tube; wire output doublesInference
The main focus is medical devices; uses in other fields do not appearThe official site’s descriptions of applications center on medical devicesSourced (other fields not confirmed either way)
One inference in more detail

The January 2024 partnership with ATI shows that Confluent is the party investing in ATI’s facilities, not the party building its own melting plant Sourced. ATI’s report (filed with the U.S. SEC) says Confluent will invest US$50 million and that ATI expects to more than triple its nitinol production by fiscal 2027. We found no statement that Confluent itself melts the nitinol that becomes its tube and wire. From this we read a division of labor in which melting is left to a specialist, while Confluent concentrates on converting to tube and wire and on making parts. However, the company’s word “vertically integrated” and a structure that relies on another company for melting appear to sit in tension. The company does not explain this, so it remains an inference Not yet confirmed.

9. Partnership map

Investment and partnership relationships around Confluent Only relationships stated by the company and in ATI’s U.S. SEC filing. Customer names are undisclosed and not shown Confluent Nitinol TPG Capital Majority investment (Jan 2022) ATI US$50M+ in melt capacity (2024) Ampersand Capital Substantial minority stake (2022) Tube Hollows Intl. Acquired; tube integration (2019) Johnson & Johnson: bought predecessor NDC in 1999, spun off in 2008 Investment, supply partnership Acquisition Shareholders, former parent (dashed)
Fig. 2 Investment and partnership relationships around Confluent. Sources: the company’s official site and press releases, and ATI Inc.’s Form ARS filed with the U.S. SEC. Only stated relationships are shown. The names of medical-device makers (customers) could not be confirmed in primary sources and are not shown.

10. Technologies and products

The summary below follows the company’s official site (figures are manufacturer’s stated values) Sourced.

AreaWhat the official site says
Nitinol tubeOuter diameter 0.5 mm (0.020 in) to 10 mm (0.400 in). Gun drilling is done in house to control wall thickness and tolerance. Grades SE508 and SE508 ELI (described by the company as a high-purity grade). Available from stock or made to order
Nitinol wireDiameters from 0.025 mm (0.001 in). Surface finish selectable as bright, ground or oxide. Grades SE510, SE508 and SE508 ELI. At the Indian plant opened in 2026: diameters of 0.004 to 0.100 in, tolerances down to ±0.0002 in, and a 4-week lead time (manufacturer’s stated values)
Nitinol partsWire forming and braiding; laser cutting and welding (fiber and ultrafast lasers); grinding; heat treatment and shape setting; microblasting; electropolishing and etching; passivation (the company states conformity to ASTM F86 and A967); attachment of radiopaque markers. Prototypes in 1 to 2 weeks, depending on raw-material availability
Design and testingFinite element analysis (FEA) simulation of durability, fatigue, crimp strain, radial force and shape setting. A menu of tests: tensile, radial force, torsion, fatigue, kink, electrochemical corrosion, metal-ion release, hydrogen content and transformation temperature (DSC and BFR methods). For each test the company names an ASTM standard; this profile does not go into the content of the standards
Beyond nitinolCatheters (balloon and complex), polymer tubing (such as Filmcast PTFE), stent coverings and biomedical textiles. Outside the scope of this profile
A materials engineer’s view: the same nitinol, but grade and downstream steps change performance

The company’s page shows side-by-side microstructure images of the standard medical grade SE508 and the high-purity grade SE508 ELI, and says both conform to ASTM F2063 Sourced. The ELI grade is presented for high-fatigue uses and small-feature parts (the company’s description). We read this as a distinction in line with the materials-side view that the amount and distribution of inclusions (oxides and carbides) affect fatigue behavior in nitinol; the company does not state this explicitly, so it is our inference. For inclusions and fatigue, see our explainer “Shape memory alloys” and our Furukawa Techno Material profile.

Nitinol is also a material whose performance is settled by downstream steps, not at purchase. The company’s service list includes shape setting by heat treatment after laser cutting, surface finishing by electropolishing and passivation, metal-ion release and corrosion tests, and hydrogen analysis. These are control items that tie material properties, such as transformation temperature (Af), the surface oxide film and nickel release, to product reliability. They are facts about the test menu the company lists, not claims that any product is safe or superior.

Nitinol wire, a tube-derived component and a shape-setting fixture illustrate processing, not clinical use.
Figure 3. Conceptual image generated with ImageGen. Nitinol wire, a tube-derived component and a shape-setting fixture illustrate processing, not clinical use. Not an actual company product, factory or measured result.

11. Risks

RiskDetailStatus
Hard to verify from outsideSales, profit, capacity and customers are not published, so there is no way for outsiders to check the size or direction of the businessSourced
Melt supply depends on a partnerNitinol melting appears to rely mainly on ATI’s facilities. ATI’s expansion is expected to be complete by fiscal 2027, and a delay would affect the supply outlookInference
Customer demand and specification changesIts products depend on medical-device makers’ development and adoption decisions. The company has said that new products are entering production, but it does not disclose individual customers or productsInference
Private-equity ownershipA private-equity fund (TPG) holds the majority. Financial details are not disclosed, and future changes in ownership cannot be foreseen from the primary sourcesSourced; outlook is an inference
Quality demands of medical usesThe company lists ISO 13485, FDA registration and similar credentials, so quality is a precondition of the business. This profile says nothing about the safety or efficacy of any individual medical deviceSourced
Self-assessments cannot be verified“Highest-volume supplier,” “market leader” and similar phrases are the company’s own words with no basis shownSourced

12. Glossary

Nitinol (nickel-titanium)
An alloy of nickel and titanium in roughly equal proportions that shows shape memory and superelasticity.
OEM
Original equipment manufacturer: the maker that owns the final product’s brand. Here, a company that sells medical devices under its own name.
Contract manufacturing (CDMO)
A business model in which a company takes on design and manufacture for customers, making materials and parts to the customer’s specification.
SE508 / SE508 ELI
Confluent’s nitinol grade names. ELI is described by the company as a high-purity grade; its abbreviation is not expanded on the company’s page.
Shape setting
A heat-treatment step that makes nitinol hold a desired shape.
DSC / BFR
Test methods for transformation temperature. DSC is differential scanning calorimetry; BFR is bend and free recovery, in which a bent sample is heated and its recovery observed.
ISO 13485
The international standard for quality management systems for medical devices.
Vertical integration
Covering several stages of the supply chain, from melting the material to making parts, within one group.

13. References

  1. Confluent Medical Technologies About Us (history, number of sites and employees). https://confluentmedical.com/about-us/
  2. Confluent Medical Technologies Official site home page (business overview, manufacturing area and other figures shown). https://confluentmedical.com/
  3. Confluent Medical Technologies Nitinol Tubing and Wire (dimensions, grades, surface finishes). https://confluentmedical.com/capabilities/nitinol-material/
  4. Confluent Medical Technologies Nitinol Components (laser cutting and welding, heat treatment, prototyping, design and testing). https://confluentmedical.com/capabilities/nitinol-products-frames/
  5. Confluent Medical Technologies Press release, “Confluent Medical Technologies Announces Nitinol Wire Center of Excellence,” 4 May 2026. https://confluentmedical.com/confluent-medical-technologies-announces-nitinol-wire-center-of-excellence/
  6. Confluent Medical Technologies Press release, “Confluent Announces Significant Investment in ATI Nitinol Melt Expansion,” 25 January 2024. https://confluentmedical.com/confluent-announces-significant-investment-in-ati-nitinol-melt-expansion/
  7. ATI Inc. Annual Report to Shareholders (Form ARS), fiscal 2023. The strategic partnership with Confluent and the expectation of expanded nitinol production (filed with the U.S. SEC). https://www.sec.gov/Archives/edgar/data/1018963/000119312524080441/d927640dars.pdf
  8. Confluent Medical Technologies Press release, “Confluent Medical Announces Significant Strategic Investment From TPG,” 5 January 2022. https://confluentmedical.com/confluent-medical-announces-significant-strategic-investment-from-tpg/
  9. Confluent Medical Technologies Press release, “Grand Opening of Costa Rica Expansion,” 18 August 2022. https://confluentmedical.com/confluent-medical-technologies-announces-grand-opening-of-costa-rica-expansion/
  10. Confluent Medical Technologies Press release, “Dean Schauer Appointed Chairman of the Board,” September 2024, which states that TPG invested in 2022. https://confluentmedical.com/dean-schauer-appointed-chairman-of-the-board-of-confluent-medical-technologies/
  11. Confluent Medical Technologies Quality Documents (ISO 13485, FDA registration, MDSAP, cleanroom statements). https://confluentmedical.com/about-us/quality-documents/
  12. Confluent Medical Technologies Management Team. https://confluentmedical.com/about-us/management-team/
  13. Confluent Medical Technologies Nitinol University (a one-day training course on nitinol). https://confluentmedical.com/tech-center/nitinol-university/
  14. Confluent Medical Technologies Press release, “Tom Testa Named Chief Operating Officer,” dated 30 April 2026. https://confluentmedical.com/confluent-medical-technologies-names-tom-testaas-chief-operating-officer/
  15. Confluent Medical Technologies Newsroom (list of press releases, 2022 to 2026). https://confluentmedical.com/newsroom/

14. Claim-to-source audit

Claim in the textStatusSource
History (1991 founding of NDC, 1999 J&J acquisition, 2008 spin-off, acquisitions from 2015 to 2019, 2016 rename, sites and investments from 2020 to 2024)SourcedReference 1 https://confluentmedical.com/about-us/
More than 2,000 employees, eight sites (U.S., Costa Rica, India), manufacturing area, and the engineer count shownSourced (company display)References 1, 2 https://confluentmedical.com/about-us/ https://confluentmedical.com/
Nitinol tube and wire dimensions, grades and surface finishesSourced (manufacturer’s stated values)Reference 3 https://confluentmedical.com/capabilities/nitinol-material/
Nitinol part processing (laser, heat treatment, polishing), prototype lead time, design and test menuSourced (manufacturer’s stated values)Reference 4 https://confluentmedical.com/capabilities/nitinol-products-frames/
Nitinol Wire Center of Excellence (Hyderabad, 26,000 sq. ft., wire output doubled, 4-week lead time)Sourced (company announcement)Reference 5 https://confluentmedical.com/confluent-medical-technologies-announces-nitinol-wire-center-of-excellence/
Investment of more than US$50 million in ATI’s melt expansion, and the fulfillment-partner arrangementSourced (company announcement)Reference 6 https://confluentmedical.com/confluent-announces-significant-investment-in-ati-nitinol-melt-expansion/
ATI’s report on its partnership with Confluent and its expectation of more than tripling production by fiscal 2027Sourced (ATI’s U.S. SEC filing)Reference 7 https://www.sec.gov/Archives/edgar/data/1018963/000119312524080441/d927640dars.pdf
TPG Capital’s majority investment and Ampersand’s minority stakeSourced (company announcements)References 8, 10 https://confluentmedical.com/confluent-medical-announces-significant-strategic-investment-from-tpg/ https://confluentmedical.com/dean-schauer-appointed-chairman-of-the-board-of-confluent-medical-technologies/
Expansion of 66,000 sq. ft. at the Costa Rica site (August 2022)Sourced (company announcement)Reference 9 https://confluentmedical.com/confluent-medical-technologies-announces-grand-opening-of-costa-rica-expansion/
ISO 13485, FDA registration, MDSAP and ISO 8 cleanroom statementsSourced (company statement)Reference 11 https://confluentmedical.com/about-us/quality-documents/
Management team and the COO appointment (April 2026)SourcedReferences 12, 14 https://confluentmedical.com/about-us/management-team/ https://confluentmedical.com/confluent-medical-technologies-names-tom-testaas-chief-operating-officer/
Content and frequency of Nitinol UniversitySourcedReference 13 https://confluentmedical.com/tech-center/nitinol-university/
List and datelines of press releasesSourcedReference 15 https://confluentmedical.com/newsroom/
Confluent’s type (components and devices primary, materials secondary)Our calculationOur own classification in this article
Sales, profit, nitinol production capacity, customer names and total capital expenditureNot yet confirmedNot disclosed or not stated; we do not estimate them. Reference 1 https://confluentmedical.com/about-us/
University joint research and public fundingNot yet confirmedNot confirmed; we do not assert that none exist. Reference 1 https://confluentmedical.com/about-us/
Completion timing of ATI’s expansion and future output in IndiaNot yet confirmedPlans of the company and its partner, not achieved results. References 5, 7 https://confluentmedical.com/confluent-medical-technologies-announces-nitinol-wire-center-of-excellence/ https://www.sec.gov/Archives/edgar/data/1018963/000119312524080441/d927640dars.pdf
The phrases “highest-volume supplier,” “market leader” and “world’s purest”Sourced (company’s words; not adopted because no basis is shown)References 3, 4 https://confluentmedical.com/capabilities/nitinol-material/ https://confluentmedical.com/capabilities/nitinol-products-frames/
The statement that nitinol demand grows at 18% a yearSourced (company announcement; not adopted because no source is given)Reference 6 https://confluentmedical.com/confluent-announces-significant-investment-in-ati-nitinol-melt-expansion/
That it uses ATI’s facilities rather than own a melting operationInferenceOur own reading of the description of the investment in ATI
That it aims to scale by separating wire and tube sitesInferenceOur own reading of the announcement of the Indian plant
Dependence on a partner for melt supply, on customer demand, and the uncertainty of outlook under fund ownershipInferenceOur own reading of the partnership structure and ownership structure

Last updated: 10 October 2026 / Troy Technical
This article rests on Confluent Medical Technologies’ official site and press releases and on ATI Inc.’s filing with the U.S. SEC. The company is unlisted and publishes no sales, profit or other financial information. We use no market-research estimates or press-report figures. Product dimensions and lead times are the company’s stated values, and no comparison with other makers’ products is made. This article is not advice about medical devices or treatment. Passages marked “Inference” are our own reading of the primary sources and are not statements by the company.

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