What is Structural Heart disease?
Structural heart disease is a broad term involving multiple conditions mainly in connection with the heart’s anatomical structure and includes:
- Valves
- Chambers
- Walls
- Pockets
- Muscles
and their functions. It’s a fast-growing dynamic field in heart medicine. Given the constant advancements in technology, the need and demand for distinct minimally invasive procedures have been increasing rapidly.
Quick review of the Structural Heart device market
By the year 2028 the Structural Heart Device market is estimated to reach over USD 22.82 billion in value with a Compound Annual Growth Rate (CAGR) of 9.8% during this time period. Growing prevalence of cardiovascular diseases and metabolic disorders, especially in developing countries are driving this growth. In addition, increased occurrence of coronary artery disease, heart failure & chronic kidney disease will contribute to the high growth rates over the next years. Technological advancements, growing investments in R&D, improved device design and procedure techniques such as minimally invasive surgery techniques are supporting the growth rate.
Structural heart techniques and devices are minimally invasive in nature. However, they are highly preferred over any other techniques, like open heart surgeries. Structural Heart devices include cardiac rhythm management devices such as implantable cardioverter defibrillators (ICDs), pacemakers, and ventricular assist devices.
Advanced Laser-Processing for Structural Heart Devices:
AMETEK EMC has been meeting the emerging demand for minimally invasive structural heart procedures and critical cardiac components for several decades. Precision Nitinol components and welded assemblies along with complex delivery systems are some of the key products that AMETEK EMC manufactures for the structural heart market.
- Laser-cut flexible shafts for delivery systems,
- Laser-cut “garages” for heart valve frames, and
- Laser-welded delivery shaft assemblies for catheter-based heart procedures.
Most of our structural heart disease devices are developed and manufactured at our US-based facility in Waukegan, Illinois.
Laserage, AMETEK EMC’s specialist brand for laser processing has the capability to reliably laser-weld key implant metal assemblies. Our laser-processed solutions offer our customers high reliability, lower manufacturing & operational costs to other manufacturing processes, outstanding accuracy and ultimately better patient outcomes.
Different Structural Heart Disease Procedures:
1. Catheter-based
One type of structural heart procedure is catheter-based. These procedures involve a catheter introduced into the body through peripheral arteries. Frequently, the catheters are made of small flexible hollow tubes that allow a variety of instruments and implants to be passed through to repair a defect or to deliver treatment devices into the inside of the heart itself.
Delivery catheter for Structural Heart implant
2. Instrument-based
Another type of structural heart procedure is instrument-based which involves a stiff shaft that goes into the body, through the chest, and straight into the heart section that needs surgical repair or treatment.
Semi-ridged shaft for delivery of Heart valve replacement. The “Garage”.
3. Open-heart surgery
Of course, open-heart surgery is also regularly performed on patients that require structural heart repairs.
Structural Heart valve replacement
4. Minimally invasive surgery
In many cases, if the evidence and expert diagnosis allow, minimally invasive structural heart procedures are given priority over high-risk and longer recovery open-heart surgeries. Structural heart procedures also differ greatly from case to case.
5. Transcatheter aortic valve replacement (TAVR)
One of the most common structural heart procedures in the last ten years has been transcatheter aortic valve replacement (TAVR). During TAVR, a substitute aortic valve is placed inside the old diseased aortic valve to facilitate better valve function. AMETEK EMC has been involved with the engineering, development, and manufacturing procedures of aortic heart valve frames for decades.
Heart valve concepts
6 . Left atrium appendage occluder (LAAO)
Another common structural heart procedure is the left atrium appendage occluder (LAAO). The most common way to occlude the left atrium in patients that have AF or are at risk of blood clots is to percutaneously introduce a coated nickel-titanium (Nitinol) structure into the left atrium. This can isolate the left atrium appendage and effectively eliminates the risk of further problems. These devices are introduced through long flexible laser-cut catheter shafts. The Nitinol frame is often laser-cut and electro-polished.
7. Transcatheter mitral valve replacement (TMVR)
A few of the lesser known but still troublesome areas within the heart that possibly need repair or replacement is the mitral heart valve. This can be addressed through transcatheter mitral valve replacement (TMVR) and the tricuspid sections or transcatheter mitral tricuspid treatment (TMTT). These procedures will require extremely flexible catheter shafts as well as precision implants. The implants might be Nitinol but possible could be high-grade stainless or other “spring” like alloys of metal. Many of these components can be laser-cut and the flexible shafts require laser-welded assembly as well.
Precision laser-cut stainless steel tubing, laser-welded assembly of delivery shafts and micro-blasting
8. Reverse pressure differentials treatment
One last area of structural heart repair that is starting to get more traction is the treatment of reverse pressure differentials in the heart. These problems can lead to heart failure but can be treated by allowing the heart chambers to stabilize pressures within themselves. This requires shunts to be surgically installed between heart chambers in specific locations. While not necessarily pumping more blood to the heart, the heart muscle itself can “rest” more when chamber pressures are allowed to balance. The procedures require flexible catheters as well as flexible Nitinol implants that can be laser-cut and finished at AMETEK EMC.
One common feature in percutaneous structural heart treatment regardless of the procedure is a robust flexible delivery system.
Structural heart delivery collar
AMETEK EMC is a leading partner in the Structural Heart Device Market
AMETEK EMC offers a long list of engineering and manufacturing capabilities across all niche segments. With the benefit of three leading expert brands,
Laserage,
Avicenna, and
TSE, each specialist in their own processes, we collaborate on component innovations and assemblies for our customers and their patients. With 40 years’ experience in the medical device market and a team of highly experienced engineers, AMETEK EMC is the ideal partner to manufacture highly advanced components for structural heart devices. We continuously focus on meeting or exceeding customers’ expectations in the development of surgical instruments, pre-production, commercialized manufacturing, supply chain management, and quality assurance.