LeMaitre Vascular, Inc. provides medical devices and human tissue cryopreservation services largely used in the treatment of peripheral vascular disease, end-stage renal disease, and cardiovascular disease. The company develops, manufactures, and markets vascular devices to address the needs of vascular surgeons and, to a lesser degree, other specialties, such as cardiac surgeons, general surgeons, and neurosurgeons. The company’s diversified portfolio of devices consists of brand name products...
LeMaitre Vascular, Inc. provides medical devices and human tissue cryopreservation services largely used in the treatment of peripheral vascular disease, end-stage renal disease, and cardiovascular disease. The company develops, manufactures, and markets vascular devices to address the needs of vascular surgeons and, to a lesser degree, other specialties, such as cardiac surgeons, general surgeons, and neurosurgeons. The company’s diversified portfolio of devices consists of brand name products that are used in arteries and veins and are well known to vascular surgeons. The company’s principal product offerings are sold globally, primarily in the United States, Europe, Canada and Asia Pacific.
The company sells its products and services primarily through a direct sales force. As of December 31, 2024, the company's sales force comprised 152 sales representatives in North America, Europe, the United Kingdom, or U.K., and the Asia Pacific, including four export managers. The company's worldwide headquarters is located in Burlington, Massachusetts, and it also has a North American sales office in Vaughan, Canada. The company has European sales offices in Milan, Italy; Madrid, Spain; Hereford, England; Dublin, Ireland; and Maisons-Alfort, France. The company's has Asia Pacific sales offices in Tokyo, Japan; Shanghai, China; Kensington, Australia; Seoul, Korea; and Bangkok, Thailand. During the year ended December 31, 2024, approximately 95% of the company's net sales were generated in territories in which it employs direct sales representatives. The company also sells its products in other countries through distributors.
Business Strategies
The company has grown its business by using a three-pronged strategy: pursuing a focused call point, competing for sales of low-rivalry, niche products, and expanding its worldwide direct sales force while acquiring complementary devices. The company has used acquisitions as a primary means of further penetrating the peripheral vascular device market, and it expects to continue this strategy in the future. The company manufactures most of its products in its Burlington, Massachusetts headquarters.
The company has historically directed its product offerings and selling efforts towards the vascular surgeon, and estimates that in 2024 approximately 80% of its sales were from devices and cryopreserved tissue used by vascular surgeons. As vascular surgeons typically perform both open vascular surgeries and endovascular procedures, the company sells devices in both the open and endovascular markets to the same end user. More recently, the company has begun to focus on adjacent market end users, such as cardiac surgeons, who can be served by its devices and tissue processing capabilities. The company seeks to build and maintain leading positions in niche segments, which it defines as under $300 million in annual worldwide revenue.
The company sells its products primarily through a direct sales force in North America, Europe, and Asia Pacific. It ended 2024 with 152 direct sales representatives, including four export managers. For the year ended December 31, 2024, approximately 95% of the company's net sales were generated through its direct-to-hospital sales force, and no single hospital customer accounted for more than 2% of its net sales. The company intends to further expand and diversify its product offerings and add new technology platforms, mostly through acquisitions. It continually evaluates the acquisition of additional product lines and businesses that may be complementary to its product offerings, refines its current product lines, or develops new applications for its existing technologies. The company also obtains regulatory approvals for its devices and services in new segments and geographies in order to further access the broader peripheral vascular device market and select other markets.
The company manufactures most of its devices in-house, having relocated the manufacturing operations of 22 of its 24 acquisitions to its Burlington, Massachusetts headquarters. The human tissue processing and cryopreservation operations associated with RestoreFlow allografts occur in its Fox River Grove, Illinois facility. Artegraft biologic graft production takes place in its North Brunswick, New Jersey facility.
Products and Services
The company's portfolio of product lines is primarily used to treat vascular disease, most of which are used in open vascular surgery and dialysis access. The company also offers human vascular and cardiac tissue cryopreservation services. No single product line accounted for more than 20% of the company's revenues in 2024, 2023, or 2022.
The company's product offerings include a suite of biologic products. These offerings include the XenoSure patch (bovine pericardium), CardioCel and VascuCel patches (bovine pericardium), Artegraft (bovine carotid artery), Omniflow II biosynthetic graft (ovine tissue and synthetic mesh), RestoreFlow allograft cryopreservation services (human cadaveric tissue), and cardiovascular patches (porcine extracellular matrix) that it distributes for Elutia Inc. These biologic offerings represented 52% of the company's sales in 2024, 51% of its sales in 2023, and 49% of its sales in 2022.
Allografts
Through its RestoreFlow allograft business, the company provides human cadaver tissue cryopreservation services, in particular the processing and cryopreservation of veins, arteries, and cardiac valved conduits. The company's RestoreFlow allografts are cryopreserved human tissue grafts, including saphenous veins, femoral veins and arteries, aorta and iliac arteries, aortic and pulmonary valved conduits, and pulmonary patches. These allografts are used in a variety of vascular reconstructions such as peripheral bypass, hemodialysis access, and aortic infections, as well as in cardiac repair and reconstruction.
Balloon Catheters for Embolectomy and Thrombectomy
The company's TufTex and Syntel lines of embolectomy catheters are used to remove blood clots from arteries. It sells single-lumen latex and latex-free embolectomy catheters, as well as dual-lumen latex and latex-free embolectomy catheters. The dual-lumen embolectomy catheters enable clot removal and simultaneous irrigation or guide-wire trackability. The company's Syntel thrombectomy catheter features a silicone balloon and is designed for removing thrombi in the venous system.
Balloon Catheters for Occlusion and Perfusion
The company's occlusion catheters temporarily occlude blood flow to allow the surgeon time and space to complete a procedure. Perfusion catheters perfuse blood and other fluids into the vasculature. Its Pruitt line of occlusion and perfusion catheters reduces vessel trauma by using internal balloon fixation rather than traditional external clamping.
Bovine Grafts
The company's Artegraft biologic graft is a bovine carotid artery used primarily for dialysis access. Its biological fibrous matrix is processed to enhance long-term patency and provide a cross-linked conduit that is flexible and compliant. Artegraft is also indicated for lower extremity bypass.
Cardiac and Vascular Patches
The company's XenoSure biologic patches are made from bovine pericardium and are used primarily for closure of vessels after surgical intervention. The company's VascuCel and CardioCel biologic patches are acellular, collagen bioscaffolds with optimized biocompatibility and minimal aldehyde toxicity. These bovine pericardium patches are used in vessel repair as well as heart repair and reconstruction, including neonatal repairs.
The cardiovascular patches that the company distributes for Elutia are made of an extracellular matrix designed to decrease inflammation and stimulate the formation of healthy tissue. These porcine patches are used in heart repair as well as vessel repair and reconstruction, including neonatal repairs.
Carotid Shunts
The company's Pruitt F3 and Flexcel carotid shunts are used to temporarily shunt blood to the brain while the surgeon removes plaque during carotid endarterectomy surgery. The Pruitt F3 shunt features internal balloon fixation. The Flexcel shunt is a non-balloon shunt offered for surgeons who prefer external fixation.
Closure Systems
The company's AnastoClip AC and AnastoClip GC closure systems attach vessels to one another with titanium clips instead of sutures. These closure systems create an interrupted anastomosis that expands and contracts as the vessel pulses. The AnastoClip AC and AnastoClip GC closure systems also enable dura closure in neuro applications.
Ovine Vascular Grafts
The company's Omniflow II biosynthetic vascular graft is a composite of cross-linked ovine collagen with a polyester mesh endoskeleton. It is indicated for lower extremity bypass and dialysis access.
Polyester Vascular Grafts
The company's AlboGraft and Cardial vascular grafts are collagen-impregnated polyester woven and knitted grafts used to bypass or replace diseased arteries. These prostheses are available in straight tube and bifurcated versions.
Phlebectomy System
The company's PhasTIPP Powered Phlebectomy System is indicated for use in phlebectomy procedures for resection and ablation of varicose veins. The illuminator is also indicated for use without the resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy case.
ePTFE Vascular Grafts
The company's LifeSpan vascular graft is an expanded polytetrafluoroethylene (ePTFE) graft used to bypass or replace diseased arteries and to create dialysis access sites. LifeSpan is available in both regular and thin wall options with optional full or partial external spiral support. The company's stepped and tapered LifeSpan grafts are designed to reduce the risk of steal syndrome and high cardiac output.
Radiopaque Tape
The company's VascuTape radiopaque tape is a flexible, medical-grade tape with centimeter or millimeter markings printed with a proprietary radiopaque ink which is visible to the eye and an x-ray machine or fluoroscope. VascuTape is applied to the skin and provides surgeons and interventionalists with a simple way to cross-reference between the inside and the outside of a patient’s body.
Valvulotomes
The company's valvulotomes cut or disrupt valves in the saphenous vein, a vein that runs from the foot to the groin, so the vein can be repurposed as an artery to carry blood past diseased arteries to the lower leg or foot. The company believes its valvulotomes reduce costs for hospitals by enabling lower extremity bypass surgery to be performed with several small incisions rather than one continuous ankle-to-groin incision, thereby reducing hospital stays and wound complications.
Sales and Marketing
As of December 31, 2024, the company employed sales representatives, including export managers. The company's marketing efforts include direct mail, digital marketing, and exhibitions at medical congresses, which it believes are important to its brand development. The company’s marketing allows it to connect with vascular surgeons who are beyond the reach of its direct sales force. The company also provides training to vascular surgeons on specific procedures, including in situ bypass, AV access, carotid endarterectomy, and interrupted anastomosis, as well as a general surgical skills training program targeting less-experienced doctors.
Research and Development
For the year ended December 31, 2024, the company's research and development expenses included $15.7 million.
Competition
The company competes with a range of companies. Notable larger competitors include Abbott, Baxter, Artivion, Becton, Dickinson, Edwards Lifesciences, Getinge, LifeNet Health, Terumo, and W. L. Gore.
Intellectual Property
The company maintains a limited portfolio of patents in the United States, and its issued U.S. patents are set to expire through 2031. The company relies on common law and registered trademarks to protect its brands. Some of the company's registered trademarks include LeMaitre, Artegraft, XenoSure, Pruitt, VascuTape, Glow ‘N Tell, and RestoreFlow, each of which is registered in the United States, the EU, or both, and in certain cases in other foreign countries.
Customers
The company's sales are not dependent on any single customer or distributor, and it continues to expand its distribution channel worldwide through direct sales representatives and independent distributors.
Government Regulation
Most of the company's products are medical devices subject to extensive regulation by the FDA under 21 U.S. Code Chapter 9, the Federal Food, Drug, and Cosmetic Act, or the FDCA. FDA regulations govern, among other things, product development, testing, manufacturing, packaging, labeling, storage, clearance or approval, advertising and promotion, sales and distribution, and import and export.
The company is subject to inspection and marketing surveillance by the FDA to determine its compliance with regulatory requirements. The most recent FDA inspection of the company's Burlington facility was in May 2023, the results of which yielded one observation that was subsequently addressed. The company participates in the Medical Device Single Audit Program, or MDSAP, which allows manufacturers to undergo a universal quality system audit that is accepted in the United States, Japan, Australia, Canada, and Brazil in lieu of individual audits by each regulator. Maintenance of this certification is a requirement to sell in certain geographies, including Canada. Failure to maintain this certification in good standing could result in suspension of the company's sales efforts in Canada or other geographies. The company's last MDSAP audit was in July 2024, and the audit results were deemed satisfactory by SGS, its notified body. Additionally, the company's New Jersey facility underwent its first MDSAP audit in October 2024 and received certification in January 2025.
The company's allografts are subject to extensive regulation by the FDA under Title 21 of the Code of Federal Regulations, Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products). These regulations were promulgated under Section 361 of the Public Health Service Act, which authorized the FDA to issue regulations to prevent the spread of communicable disease. Under these regulations, the FDA requires registration of establishments that process human cells, tissues, and cellular and tissue-based products. These FDA regulations also establish donor-eligibility criteria, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by such products, including through donor screening and testing. The company's Fox River Grove, Illinois facility is registered with the FDA’s Center for Biologics Evaluation and Research. The regulations also provide for FDA inspection of tissue establishments. The FDA most recently inspected the company's Fox River Grove, Illinois facility in April 2023, and the results were satisfactory.
The company voluntarily complies with the standards of the tissue bank industry’s accreditation organization, the American Association of Tissue Banks, or AATB. The AATB has established standards for tissue banking and administers an accreditation program. Accreditation must be renewed every three years. The company's Fox River Grove, Illinois facility has been accredited by the AATB for the processing, storage, and distribution of cardiac and vascular tissue for transplantation through May 13, 2027. The AATB is entitled to inspect members at any time. The AATB most recently inspected the company's Fox River Grove, Illinois facility in November 2023, and the results were satisfactory.
History
The company was founded in 1983. It was incorporated in Massachusetts in 1983 as Vascutech, Inc. In 1998, the company was reincorporated in Delaware. The company changed its name to LeMaitre Vascular, Inc. in 2001.