Teleflex has won a second FDA Breakthrough Device Designation for Freesolve RMS, a resorbable magnesium coronary scaffold the company picked up through its 2025 acquisition of Biotronik's vascular intervention business. The 22 October 2026 designation covers coronary use; the platform's first Breakthrough tag, in 2024, covered a separate below-the-knee peripheral application. Freesolve is already CE-marked and sold commercially outside the United States, where it remains investigational while a 1,859-patient pivotal trial enrolls toward a future approval filing.
What four years of first-in-human data actually showed
The case for Freesolve RMS rests so far on BIOMAG-I, a 116-patient, single-arm, European first-in-human study. Four-year results, presented at EuroPCR and reported in a company release, found 3.5% target lesion failure by Kaplan-Meier estimate, with no cardiac death, no target-vessel heart attack and no confirmed scaffold thrombosis through four years of follow-up; the failure curve largely flattened after the second year. Those figures are company-reported and have not, as far as we can establish, been independently adjudicated or published in a peer-reviewed journal. Teleflex's own pivotal comparison against a standard drug-eluting stent — the trial that will actually test the scaffold's claims — is BIOMAG-III, which began US enrollment in June 2026 and is still recruiting.
“We believe Freesolve RMS has the potential to reshape the coronary intervention landscape, and the BIOMAG-III study could be the catalyst to drive that.” Dr. Georg Nollert, Vice President, Medical Affairs, Teleflex — 23 June 2026, on the launch of the BIOMAG-III pivotal trial (not a statement about the 22 October Breakthrough designation itself)
Freesolve RMS in four figures
Figures from Teleflex's 22 October 2026 designation announcement and its BIOMAG-I and BIOMAG-III trial disclosures.
The 2017 withdrawal every resorbable scaffold answers to
Any resorbable coronary scaffold launches into the shadow of Abbott's Absorb, a polymer-based scaffold Abbott pulled from commercial sale in September 2017 after two-year trial data showed significantly more target-lesion failure and scaffold thrombosis than a standard drug-eluting stent, prompting an FDA safety communication months earlier. Absorb's polymer struts were thick — roughly 156 microns — to compensate for a material weaker than metal, and took over two years to fully resorb. Freesolve RMS is built differently: a magnesium alloy strong enough to support thinner struts, with Teleflex reporting roughly 99% of the scaffold resorbed within 12 months rather than two-plus years. Whether that material difference actually translates into better outcomes is precisely what BIOMAG-III, not BIOMAG-I's single-arm results, is designed to test.
Three things Teleflex is betting the material fixes
Magnesium, not polymer
A metal alloy strong enough to support thinner struts than Absorb's polymer needed, resorbing in about a year rather than more than two — the core bet behind every magnesium scaffold since Biotronik's original Magmaris.
Already sold in four regions
CE-marked since February 2024 and commercially available across parts of Europe, Asia-Pacific, South America and the Middle East, giving Teleflex real-world sales experience before any US approval filing.
Third generation of a known design
Freesolve descends directly from Biotronik's Magmaris (CE-marked 2016), the scaffold with the longest published magnesium-platform follow-up (60 months) of any device in this class.
A field that has tried this before, with mixed results
Freesolve is not the only attempt to build on what Absorb got wrong. Elixir Medical's DynamX Bioadaptor takes a different approach entirely — a permanent cobalt-chromium structure held together by a polymer that resorbs after about six months, 'unlocking' the scaffold to let the vessel move naturally again rather than disappearing outright. DynamX won its own FDA Breakthrough Device Designation in 2024, and a 445-patient randomized trial reported a 12-month target-lesion-failure rate of 1.8%, against 2.8% for a Medtronic Resolute Onyx comparator — figures that, like Freesolve's, come from company-sponsored research. Neither DynamX nor Freesolve is yet approved for US commercial sale; both are still proving their case against conventional drug-eluting stents, which remain the default treatment with decades of outcomes data behind them.
Freesolve RMS against the resorbable-scaffold field
| Product | Material | Resorption | US status |
|---|---|---|---|
| Freesolve RMS (Teleflex) | Magnesium alloy | ~99% within 12 months | Investigational; 2nd Breakthrough Designation, Oct 2026 |
| Magmaris (Biotronik) | Magnesium alloy (predecessor design) | Full resorption reported by ~12–14 months | Not sold in the US |
| DynamX Bioadaptor (Elixir Medical) | Cobalt-chromium with resorbable polymer locks | Polymer locks resorb at ~6 months; metal structure remains | Investigational; FDA Breakthrough Designation, 2024 |
| Absorb BVS (Abbott, discontinued) | PLLA polymer | Resorption over 2+ years | Withdrawn from sale, September 2017 |
| Xience (Abbott) | Permanent cobalt-chromium, drug-eluting | Does not resorb | FDA approved; standard-of-care comparator in Freesolve's own trials |
From each company's own disclosures and public trial/regulatory records; not a clinical comparison.
A market a withdrawn product still shadows
The broader coronary stent market is large and slow-growing: Fortune Business Insights put it at roughly $7.0 billion in 2025, rising to about $12.3 billion by 2034. The resorbable-scaffold sub-segment Freesolve competes in is far smaller and its published forecasts disagree by more than tenfold depending on the research firm — a reflection of how small, and how unproven commercially, the category still is eight years after Absorb's withdrawal reset expectations for the entire class.
Coronary stents, and the resorbable sliver within them
$7.0B → $12.3B
Global coronary stent market, 2025 to 2034, as forecast by Fortune Business Insights; the bioresorbable-scaffold sub-segment shown separately, since estimates for it vary widely by publisher.
Sources: Fortune Business Insights, Coronary Stents Market report, 2026 · QYResearch, Bioresorbable Vascular Scaffolds Market report, 2026
Regulatory News outlook
We expect the bioresorbable-scaffold sub-segment to stay under $2 billion worldwide through the early 2030s even if BIOMAG-III reads out well, because a US approval would still only follow trial completion by several years and every resorbable scaffold is competing against drug-eluting stents with decades of outcomes data.
How we got here: QYResearch's own $0.75 billion 2024 base, compounded at its stated figures toward $1.88 billion by 2031, implies the category stays a low-single-digit percentage of the $12.3 billion total coronary stent market Fortune Business Insights forecasts for 2034 — we simply note that no currently published forecast has the resorbable segment closing that gap this decade.
What a designation does not change
A Breakthrough Device Designation speeds FDA's engagement with Teleflex during development and review; it does not clear Freesolve RMS for US sale, does not guarantee BIOMAG-III succeeds, and does not set a date by which either happens. Teleflex has disclosed that BIOMAG-III enrollment began in June 2026 with a target of 1,859 patients across up to 120 sites, including up to 60 in the United States, comparing Freesolve against Abbott's Xience stent on 12-month target lesion failure — but the company has not published an estimated completion date or a premarket approval filing timeline. The acquisition that brought Freesolve to Teleflex closed in mid-2025, alongside a broader plan to split Teleflex into two separately traded companies; whether that separation has itself closed was not something we could confirm as of publication, and we note it here rather than assume either way.
From aviation controls to a second Breakthrough tag
Freesolve's road through two companies
- 1943
Teleflex founded
Founded to make mechanical push-pull controls for aviation, later diversifying into medical devices through decades of acquisitions.
- 2016
Magmaris CE-marked
Biotronik's second-generation magnesium scaffold, Freesolve's direct predecessor, wins a CE mark; it is still not sold in the US.
- March 2024
First Breakthrough Designation
FDA grants Freesolve RMS a Breakthrough Device Designation for below-the-knee chronic limb-threatening ischemia, while the device still belongs to Biotronik.
- February 2025
Acquisition and separation announced
Teleflex agrees to acquire Biotronik's Vascular Intervention business for roughly €760 million, alongside a plan to split Teleflex itself into two publicly traded companies.
- July 2025
Acquisition closes
Teleflex completes the purchase, bringing Freesolve RMS and the rest of Biotronik's coronary and peripheral scaffold portfolio into its Interventional business.
- June 2026
BIOMAG-III begins enrolling
Teleflex's US pivotal trial starts enrollment, planning 1,859 patients against a standard drug-eluting stent comparator.
- 22 October 2026
Second Breakthrough Designation
FDA grants a second Breakthrough Device Designation, this time for coronary PCI use.
- Ahead
BIOMAG-III results, then a filing
No estimated trial-completion date or premarket approval filing timeline has been disclosed.
Sources & further reading
- Teleflex, “Teleflex Announces FDA Breakthrough Device Designation for Freesolve Resorbable Magnesium Scaffold,” 22 October 2026 (BusinessWire). financialcontent.com
- MassDevice, “Teleflex's Freesolve RMS gets FDA breakthrough device designation,” 22 October 2026. massdevice.com
- Teleflex, “Teleflex Initiates Enrollment in Global BIOMAG-III Pivotal Trial of Freesolve Resorbable Magnesium Scaffold,” 23 June 2026 (BusinessWire). businesswire.com
- Teleflex, “Four-Year BIOMAG-I Study Results Presented at EuroPCR Confirm Long-Term Safety and Sustained Performance of the Freesolve Resorbable Magnesium Scaffold (DREAMS 3G),” 9 June 2026. chartmill.com
- Teleflex Investor Relations, “Teleflex Completes Acquisition of BIOTRONIK's Vascular Intervention Business.” investors.teleflex.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA designate for Teleflex?
A Breakthrough Device Designation for Freesolve RMS, a resorbable magnesium coronary scaffold, for use in percutaneous coronary intervention (PCI). Announced 22 October 2026, it is the platform's second Breakthrough designation; the first, in 2024, covered a below-the-knee peripheral-artery use.
Is Freesolve RMS approved for sale in the US?
No. It is CE-marked and commercially available in parts of Europe, Asia-Pacific, South America and the Middle East, but in the United States it remains investigational, limited to clinical trial use pending a future FDA premarket approval application.
How is Freesolve RMS different from the Absorb scaffold Abbott withdrew in 2017?
Absorb was a polymer (PLLA) scaffold that needed thick struts and took over two years to resorb; its 2-year trial data showed higher rates of target-lesion failure and scaffold thrombosis than a standard drug-eluting stent. Freesolve uses a magnesium alloy instead, allowing thinner struts and a reported resorption of about 99% within 12 months — but no US pivotal trial has yet reported results proving it performs better than a standard stent.
When might Freesolve RMS reach the US market?
Its US pivotal trial, BIOMAG-III, began enrolling in June 2026 and plans to enroll 1,859 patients; Teleflex has not disclosed an estimated completion date or premarket approval filing timeline.
