One product. One team.
Twenty-five years.
A repositionable nitinol shape-memory hook wire for preoperative breast tumour localisation — manufactured continuously in our ISO 13485-certified European facility, and now available for direct partnership for the first time.
Repositionable, by design
Fixed-hook localisation wires give the surgeon one chance: once a steel hook opens in tissue, it stays where it landed. Our wire is different. The double-arch nitinol anchor collapses back into the cannula and redeploys — placement can be adjusted intra-procedurally until it is exactly right. This is what makes it a truly repositionable breast localization wire rather than a fixed hook.
That repositionability comes from shape-memory nitinol and from a quarter-century of manufacturing refinement dedicated to this one device. The design is clinically well established, used in European hospitals for over two decades.
Every single unit — not a sample, every unit — passes functional verification before release.
Double-arch nitinol anchor — the repositionable localization wire, explained.
The double nitinol wire construction is what allows the anchor to collapse and redeploy: two shape-memory arches, formed from a single double nitinol wire, spring open once released from the introducer cannula, then draw back in when recaptured. This double-arch nitinol anchor design is the mechanical basis of the repositionable breast localization wire, and it is why placement can be adjusted intra-procedurally instead of committed to on first deployment.
| Anchor design | Double-arch, nitinol shape-memory |
| Repositionable | Yes — collapse & redeploy in-procedure |
| Working lengths | 50 / 90 / 120 mm |
| Shaft | Echogenic, kink-resistant, twisted |
| Compatibility | Standard introducer cannulas |
| Quality control | 100% functional verification |
| Certification | ISO 13485:2016 (RINA) |
| Cleanroom | ISO 14644-1 Class 8 |
Your brand. Your CE. Our manufacturing.
OEM wire component
Bulk, non-sterile nitinol wire components. You assemble, sterilise (EO) and label under your own brand and CE marking.
Finished non-sterile assembly
Complete wire + cannula + handle assemblies, ready for your sterilisation, packaging and labelling.
Private label
We manufacture to specification under your brand, with new Instructions for Use created for your regulatory framework. You own the market.
Built for your technical file
Partners integrate our components under their own CE marking and regulatory responsibility. To make that fast, we maintain a complete supplier-qualification documentation package — mapped to ISO 13485:2016 — ready for your quality team from day one of an executed agreement.
A rare window in a proven niche
For over twenty-five years, this facility served as the dedicated manufacturing site behind one of Europe’s most widely distributed repositionable breast localisation systems. Following structural changes at the brand level, that product line is being phased out by the current rights holder.
The manufacturing capability — same team, same process, same quality system — is available for direct partnership for the first time outside its original distribution framework.
Production capacity is available for new partnerships.
Frequently asked questions
What is a repositionable localization wire?
A repositionable localization wire is a preoperative breast lesion marker that can be adjusted after initial placement. Unlike a fixed steel hook wire, it can be withdrawn back into its introducer and redeployed until positioning is confirmed correct.
What is a double-arch nitinol anchor?
A double-arch nitinol anchor is a shape-memory anchor formed from a double nitinol wire. It opens into two arches once released from the introducer cannula and collapses back on retraction, which is what makes the wire repositionable.
What OEM supply configurations are available?
Pharmtex Medical offers three OEM configurations: bulk non-sterile wire components, finished non-sterile assemblies, and private-label manufacturing under the partner’s own brand and regulatory framework.
Is the repositionable breast localization wire clinically established?
Yes. The double-arch nitinol anchor design has been used in European hospitals for over two decades, manufactured continuously in the same ISO 13485-certified facility.
Evaluate it yourself
Specifications tell you half the story. The anchor in your hand tells you the rest.
apopov@pharmtex.com · +359 88 8675353