Led by Dr. Julio Palmaz and a proven management team of executives, physicians, scientists, and engineers, Palmaz Scientific was created in 2008 with a vision to provide a technology platform that innovates medical device science. Today this vision is realized with a potentially game changing nanotechnology platform applying a physical vapor deposition process to produce more reliable implantable prosthetic devices. This technology is supported by nearly 100 issued patents and over 100 active patent filings in process.
Even though Dr. Palmaz invented the first commercially available stent, he knew that his original stent design and those designs that followed later could be significantly improved with respect to their healing and therapeutic properties. Today's stents are manufactured using stretching, grinding, heating and welding processes. These processes create stents that look clean and shiny and continue to benefit millions of patients since first introduced in the 1990's.
However at the surface level of the stent,- one can see grease spots at the crystal level and cracks and breaks in the polymer coating of coated stents. Both of these situations will inhibit cell growth slowing the healing process or perhaps leading to late stent thrombosis or restenosis.
Palmaz Scientific has discovered a better way to manufacture stents and most other implantable medical devices.
At the heart of the Palmaz Nanotechnology Platform are discoveries regarding how tissue and blood interact with prosthetic metal surfaces at the atomic and molecular levels. To study these phenomena, Dr. Palmaz formed Advanced Bio Prosthetic Surfaces Ltd. (ABPS) in 1999 to advance metal surface technologies using physical vapor deposition and molecular and cellular biology to develop advanced biocompatibility of materials used in implantable medical devices. Palmaz Scientific was formed in 2008 to continue the research and development begun by ABPS and to also pursue the commercialization of advanced metallurgical surface nanotechnologies for the manufacture of implantable medical devices.
Metals used in the manufacture implantable medical devices are fraught with impurities that make the healing process unpredictable and chaotic, resulting in adverse events such as stent thrombosis and restenosis. To address these issues Dr. Palmaz looked at the interactions of blood and tissue with material surfaces at atomic and molecular levels. He believed that reducing or eliminating impurities and the random variability in the structure of the material would make the healing process predictable. See Appendix A for a depiction of how cells behave with metal surfaces.
This research on how tissue and blood interact with prosthetic metal surfaces at the atomic and molecular levels led Palmaz Scientific to three important discoveries:
The leadership of ABPS put together a unique group of scientists, engineers and technologists combining metallurgy, high vacuum physical and chemical vapor deposition and molecular and cellular biology expertise. In a few years, breakthrough developments made by the group yielded high purity, optimized materials and techniques allowing controlled fabrication methods not seen before, such as patterned ultra-thin 3D metal structures, suited for device development. From this effort, other important concepts arose, namely the importance of cellular guidance by topographical surface features and controlled material heterogeneities for optimizing cellular interactions with material surfaces.
Thin metal films can be built using physical vapor deposition ("PVD"), a process similar to that used in the semiconductor industry. PVD results in high purity metals, which promotes cell growth, and high strength metal structures to form low profile devices which allow for stenting of sites not targeted with previously available technology.
The first practical project arising from this array of capabilities was the all metal micromesh covered stent designed to address potentially embologenic targets (sites prone to release particles downstream during angioplasty and stenting). This consisted of a very fine mesh of vacuum deposited metal, roughly 5 times thinner than a human hair, covering a conventional stent frame.
The photomicrograph above illustrates the construction of the Company's all metal micromesh thin film covering. (130x magnification)
The mesh prevents particles from dislodging and occluding vessels downstream, constituting a pre-emptive embolic protection for sites prone to this complication such as degenerated coronary saphenous vein bypass, carotid and renal arteries. Other devices were prototyped taking advantage of the unique design flexibility of this technology, including a metal balloon, cardiac valves, surgical mesh, surgical bypass conduit, embolic protection filter and other devices.
Thin films are thin metal deposits ranging from nanometers to millimeters in thickness. Thin film technology is not expensive to implement allowing for cost-effective enhancement to therapeutic outcomes from the implantable medical devices. Dr Palmaz developed vapor deposition process and a patterned lasering technique which results in a high strength, high purity low profile metal device. The Company initially used this process to create an all metal micromesh (<5 microns thick) covering of high purity to prototype an all metal micromesh covered stent.
Furthermore the body of knowledge regarding how tissue and blood interact with metal surfaces revealed that a unique surface micro-patterning design accelerated the attachment of endothelial cells to the metal surface. Micro engineered grooves ("Micro Grooves") induce powerful effects on cell behavior:
These processes and technologies were first developed to improve vascular stents but it was soon realized that all implantable medical devices could potentially benefit from these discoveries.