Lake Region Medical
 
 
 
CARDIO & VASCULAR: CARDIOVASCULAR & STRUCTURAL HEART
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Interventional Vascular Cardiac Surgery / Structural Heart Disease
Heart

Interventional Vascular

Lake Region offers a full range of products and services for catheter-based interventional vascular devices. In collaboration with customers, Lake Region offers comprehensive catheter design and development services in a state-of-the-art catheter development lab. Upon transition to manufacturing, Lake Region produces catheter components, subassemblies and completed devices for vascular procedures.

Device Applications
Guidewires

Lake Region offers a extensive line of OEM guidewires designed to meet the unique requirements of a range of clinical applications. Additionally, as a global leader in guidewire design and development, Lake Region manufactures custom guidewire solutions for leading medical device companies. Utilizing proprietary platform technologies and advanced wire processing technologies, Lake Region manufactures high-precision guidewires that meet the required fitness of use, criticality, and safety parameters.

Guide Catheters
Multi-use guide catheters are produced using Lake Region's proprietary catheter shaft construction and can be used to deliver contrast or provide a structure for the deployment of other minimally invasive therapies. These catheters are fundamental to most coronary and peripheral arterial procedures. Lake Region offers every capability needed to produce guide catheters, including low-cost manufacturing.

Microcatheters
Microcatheters are used to deliver embolic coils to the brain in the treatment of cerebrovascular aneurysms. High performance and high pressure ratings are required along with braiding and hydrophilic coatings. Lake Region's microcatheter capabilities include extrusion, braiding, thin wall and supple PTFE liners, composite assemblies and hydrophilic coating capabilities. The Company's turn-key solutions allow our customers to realize increased speed to market and rapid return on investment.

Ultrasound Catheters
Ultrasound catheters produce an image of a blockage or mass within a blood vessel, which provides more information than a contrast image. Lake Region's proprietary shaft construction and world class device engineering services provide our customers with a single source solution in the design and production of ultrasound catheters.

Balloon Dilatation Catheters
Balloon dilatation catheters are flexible catheters attached to a catheter shaft with a short distal circumferential balloon at the tip. They are used to widen stenotic blood vessels and heart valves. Features include the rapid exchange platform for use in the peripheral vasculature, a low balloon profile and a laser-bonded, tapered tip to promote crossability through tight stenoses, and flexible, lubricious inner shafts (and tips) to promote easier navigation through tortuous vasculature. Lake Region's technical expertise in processes such as polymer processing, thermo bonding, laser balloon bonding and hydrophilic coating combine for superior balloon catheter design.

Self-Expanding Stents & Delivery Systems
Self-expanding stents are used to hold open previously occluded vessels or structures and do not require balloons to be deployed. Lake Region has dedicated manufacturing cells in the US, Mexico and Ireland to produce self-expanding stents and related delivery systems. Lake Region supports stent alloy development, stent tube production and produces delivery catheter shafts with superior performance in stiffness and elongation—critical factors in self expanding stent delivery systems.

Balloon Expandable Delivery System

Balloon Expandable Delivery Systems
Balloon expandable delivery systems are used for a variety of angioplasty and stent delivery applications for coronary and peripheral procedures. Lake Region's catheter capabilities include extrusion, braiding, thin wall and supple PTFE liners, composite assemblies and hydrophilic coating. The Company's turn-key solutions allow our customers to realize increased speed to market and rapid return on investment.

Stents
Lake Region offers a comprehensive suite of solutions for stent applications, including tube and wire drawing, laser machining, forming, heat setting and electropolishing. In-house tube drawing capabilities include stainless steel, CoCr Alloys (MP35N & L605), Tantalum and Nitinol. Wire drawing capabilities include Platinum Alloys, MP35N, stainless steel, as well as custom alloys designed to meet customer-specific needs.

Atherectomy Devices
Atherectomy devices clear peripheral and coronary arteries by grinding, aspirating or cutting away atherosclerotic plaque build-up, allowing blood to flow freely. Lake Region utilizes proprietary catheter shaft construction and world-class device engineering services to solve your product needs.

Embolic Protection Devices
Distal projection devices protect distal vasculature during certain vascular procedures such as the removal of stenosis, preventing debris from occluding distal microvessels and reducing blood flow. Lake Region offers expertise in micro catheter design, proprietary catheter shaft construction, world-class device engineering services and assembly locations.

 

Services
Catheter Design & Development
Lake Region offers full catheter design and development services from the catheter development lab in our Idea Center. From early catheter design through manufacturing, Lake Region employs Design For Manufacturing & Assembly (DFMA) practices to realize increased speed to market and rapid return on investment for our customers. Working with our catheter development engineers, customers can utilize our in-house developed Virtual Tubing Model to design catheter shaft properties with minimal iterations, significantly reducing development time.

Catheter Assembly
Lake Region has dedicated clean rooms and manufacturing cells in the US, Mexico, Asia and Ireland to manufacture a variety of catheter-based delivery systems. From early catheter design and development through manufacturing, Lake Region employs Design For Manufacturing & Assembly (DFMA) practices to realize increased speed to market and rapid return on investment for our customers.

Finished Device / Sterile Packaging
Lake Region regularly performs final packaging and labeling. The Company is versed in several packaging methodologies and employs strict label control systems. Lake Region also provides tray and pouch vacuum sealing of devices in preparation for sterilization. Lake Region understands the criticality of packaging designs to ensure seal integrity from the point of manufacture to the surgical field. Lake Region uses proven packaging equipment and techniques to provide consistent sterile barrier packaging, meeting or surpassing US and OUS regulatory requirements.

Sterile Barrier Packaging
Lake Region provides tray and pouch vacuum sealing of devices in preparation for sterilization. It is critical that packaging designs maintain integrity from the point of manufacture to the surgical field. Lake Region utilizes processes that guarantee the integrity of product packaging, ensuring compliance to world-wide regulatory requirements.

Catheter Shaft

Components
Catheter Shafts
Lake Region provides a wide array of catheter device components. The Company's Virtual Tubing Model hastens the catheter shaft design process, often eliminating the need for multiple iterations. Lake Region's catheter shaft production includes composite tubing in both single and multi-lumen, braid reinforcement and a number of options for lubricious liners.

Marker Bands Radiopaque Marker Bands
Radiopaque marker bands are thin-walled metal tubes placed at strategic locations on a catheter for visibility under an x-ray fluoroscope and are typically made from a high density metal such as platinum, gold or tantalum. Lake Region's marker bands are produced with very tight control of dimensions and without burrs. Utilizing our proprietary processes, the Company routinely produces marker bands to achieve the tightest tolerances, the thinnest walls and the best surface and edge conditions in the medical device industry.
Molded Hubs

Molded Hubs
Lake Region has in-house injection and insert molding capabilities and is well-versed in the design and production of molded catheter components.

Fabricated Hypotube Assemblies
Lake Region's in-house vertical integration of tube drawing capabilities and automated metal working processes for skiving, laser cutting and coating allow for very competitive pricing, while increasing speed to market.

Catheter Device Services
Lake Region regularly provides value added services for catheter device customers including pad printing, laser marking and hydrophilic coating.

Balloon Expandable Delivery System

Wire Stent Frames
Lake Region regularly forms stent frames from wire materials including nitinol and stainless steel for a multitude of product applications. Wire forming is followed by a thermal set process that optimizes the mechanical properties of the materials. Lake Region has extensive experience in thermal setting and also secondary processing of Nitinol wire products with state-of-the-art processing equipment and electropolishing expertise that is among the best in the industry.

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Cardiac Surgery

Cardiac Surgery / Structural Heart Disease

Lake Region offers expertise in multiple devices and components related to cardiac surgery and structural heart disease treatment.

Device Applications
PFO Closure Devices

PFO closure devices are deployed during catheterization (rather than open surgery) to close heart defects such as atrial septal defect, patent ductus arteriosus, patent foramen ovale and ventricular septal defect. Lake Region's engineering group is well-versed in the design and assembly of PFO Closure devices, including deployment catheters. Lake Region offers expertise in steerable and non-steerable catheter delivery system design, and in every element of the catheter production process and performance testing. The Company's experience with stent frames and device deployment has also proven invaluable in the design and development of the delivery systems and supporting structure for PFO devices.

Cardiac Surgery

Vessel Harvesting Systems
Endoscopic Vessel Harvesting (EVH) is a surgical technique that may be used in conjunction with coronary artery bypass graft (CABG) surgery. For patients with coronary artery disease, a physician may recommend a bypass to restore healthy blood flow to the heart muscle. To create the bypass graft, a surgeon will remove or "harvest" healthy blood vessels from another part of the body, often from the patient's leg or arm. Lake Region is fully equipped to manufacture individual elements of EVH Systems as well as completed devices, including packaging, labeling and sterilization.

Beating Heart Surgery Systems
Beating heart surgery systems are used during off-pump cardiac bypass surgery, a procedure in which the heart is not arrested and continues to pump blood throughout the circulatory system. A tissue stabilizer holds a small area of the heart while a surgeon performs the bypass procedure. Instruments typically include stabilizers and positioners. Lake Region is equipped to manufacture individual elements of Beating Heart Systems as well as completed devices, including packaging, labeling and sterilization.

Transcatheter Heart Valves
Transcatheter heart valves (THV) involve a less-invasive procedure to replace a defective valve utilizing a catheter-base intervention. Lake Region offers expertise in steerable and non-steerable catheter delivery system design, and in every element of the catheter production process and performance testing. Lake Regions's vertical supply chain solutions for THV catheters include wire and cable fabrication, braiding, polymer, extrusion/filmcast, reflow, ablation, machined components, laser ablation, coils and laser welding. The Company's experience with stent frames and device deployment has also proven invaluable in the design and development of the delivery systems and supporting structure for THV valve frames.

Heart Valves & Leaflets
Lake Region produces heart valves and leaflets utilizing a dedicated and highly automated manufacturing cell. The Company's five-axis equipment has programmable self-replacing cutting instruments to ensure each part is fabricated to extremely precise tolerances.

Anastomosis Devices
Anastomosis devices are used to sew the proximal and distal graft during bypass surgery, providing better outcomes than traditional grafts with minimized surgery time and shortened recovery time. Lake Region has capabilities to manufacture both components and complete turnkey anastomosis devices.

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