In recent years, significant innovations for the management of superficial vein disorders have led to the migration of venous treatment from the hospital to the out-patient vein clinic setting. Endovenous thermal ablation, tumescent anesthesia, and new sclerotherapy options are but a few of the new technologies that have helped revolutionize the field. But the options for superficial vein treatment are still mostly limited to endovenous ablation of larger axial veins, phlebectomy for bulgy veins and sclerotherapy. This relatively limited toolset inspires some to keep innovating to identify and address unmet needs for the optimal treatment of venous insufficiency.
Two vein surgeons in Bend, OR , answered such a call. Like many modern vein doctors, Ed Boyle, MD , a cardiothoracic surgeon, and Andrew Jones, MD , a minimally invasive and trauma surgeon, started their careers in hospital based practice and later became specialized vein doctors who moved to the outpatient setting. They founded the Inovia Vein Specialty Center seven years ago, after recognizing a largely underserved community of venous insufficiency patients and the opportunity to further specialize in the management of venous disorders. “We were excited to be able to treat a large variety of varicose veins right in the office, rather than in the hospital, as we had been trained in our residency,” says Dr. Boyle. “However, as we gained more experience in our practice, we learned that there are many different patterns of superficial vein disorders that needed to be addressed, from large bulging branch varicosities, to reticulars, to spider veins.” In particular, the surgeons took note of the shortcomings of sclerotherapy and ambulatory phlebectomy for some types of veins.
“The treatment of small and medium size veins, typically seen with sclerotherapy, has its advantages, but also its pitfalls,” says Dr. Jones, a former recipient of the deGroot Fellowship for the American College of Phlebology (AC P). “Although sclerotherapy is a well-established, highly useful modality to treat a variety of veins, there are a number of shortcomings that I consider when determining which veins to inject and where,” notes Jones. The drawbacks can include pigmentation irregularity such as staining, shadowing,
and matting. “While I like sclerotherapy for small spider veins and foam for subcutaneous veins, I find that staining and shadowing make it less desirable for medium and small veins along the skin, such as reticular veins and smaller branch veins,” adds Boyle.
An alternative vein treatment method is ambulatory phlebectomy, also known as stab phlebectomy. “I perform phlebectomy on a large percentage of my patients undergoing endovenous ablation and am always impressed with how quickly the veins disappear without staining, shadowing or matting,” says Boyle. Phlebectomy is a technique commonly utilized for patients with larger diameter, bulging branch varicosities that are visible by bulging out the skin when the patient is standing. Phlebectomy is performed by making a small incision in the skin and inserting a phlebectomy hook in a vertical fashion through the incision to hook and excise the vein just below or adjacent to the incision. “This limits the extent to which the hook can be inserted under the skin,” says Jones. According to Boyle, “In my hands, I find phlebectomy with a simple hook most useful for larger, raised branch varicosities. But I do not find traditional vertical stab phlebectomy to be very practical for smaller branch veins, especially reticular veins and venulectasias. One of the great advantages of phlebectomy, however, is the lack of staining and shadowing and the rapidity of the recovery compared to sclerotherapy,” explains Dr. Boyle.
Inspired by the advantages of phlebectomy, as well as the limitations of sclerotherapy, doctors Boyle and Jones set out to develop novel systems to address this unmet need for small and medium sized veins close to the skin. Boyle has previously invented other medical devices and has an established network of experts with whom he has worked to design and develop innovative medical device solutions to unmet needs. He first contacted Chris Genau, a Seattle based designer and mechanical engineer to help design, develop and test the device concepts they envisioned. “Chris had a huge amount of expertise in managing medical device development projects, so we were happy to recruit him to the team,” says Boyle. “He actually started his career in race car design, having been involved in the development
of Indy and Formula 1 race cars before transitioning his career to medical device design. We were excited to involve Chris in building a device that fulfills its intended function while also focusing on human factors and aesthetics,” says Boyle. They sat down at a white board and started discussing ideas and soon a novel device began to emerge. The team recognized a budget would be needed to design and develop the technology, build prototypes, file patents, obtain regulatory clearance and test the device clinically. They formed a company, named VenX, and raised money from a consortium of venture capitalists in Nashville, TN .
After an initial round of device iteration and testing, the team traveled to Nice, France to meet with Drs. Paul Pittaluga and Sylvan Chastanet at the Rivera Vein Institute for their input. “I had met Drs. Pittaluga and Chastanet when I traveled to France for the deGroot fellowship from the AC P and was impressed with their experience and passion for phlebectomy,” says Jones. Pittaluga and Chastanet saw early device prototypes and were able to provide important input as the device design was finalized.
Working as a team, a device called the VenX ReachTM was developed to perform what they term Horizontal PhlebectomyTM . With Horizontal Phlebectomy, a manually actuated hook is located inside the shaft of a needle. After infiltration with tumescent anesthesia, the beveled needle is directed and advanced just below the skin towards the target vessel in a horizontal motion. When the device is actuated, the hook is advanced out of the needle through the beveled opening. Once exposed, the hook is angled slightly toward the skin and the vein is engaged. As the device is pulled back through the beveled skin opening, a phlebectomy is performed.
“Because the phlebectomy hook is tucked inside the core of the needle, it allows for both easy insertion and easy maneuverability of the device until the physician is ready to deploy the hook by squeezing the hand lever,” according to Jones. “This also allows the user to extend a much longer distance under and parallel to the skin.
One advantage of the device is that it allows the physician to disrupt multiple veins or multiple sections of the same vein from a single entry point, minimizing the number of procedural incisions. Unlike bare hooks that are used at multiple incisions and can be difficult to maneuver under the skin because of their blunt tips, the VenX device reaches a wider field of veins through a single access point, providing accurate placement and targeted disruption of the vessel. Further, the small incision point with the beveled needle appears to have favorable aesthetic healing properties, minimizing the lateral scarring that can occur with traditional vertical stab phlebectomy. One additional benefit is that the physician will no longer need two instruments to perform minor phlebectomy since both the disrupting element and the piercing element have now been combined into a single piece of equipment, reducing the time and complexity of the procedure.
“The goal is to disrupt a long segment of the vein in the most complete fashion with a minimum of residual inflammation, minimizing the effects commonly associated with sclerotherapy treatment in veins at the skin level,” says Jones.
“I see this not so much as a replacement for sclerotherapy or traditional phlebectomy, but as a new tool in the tool box to allow us to expand the number of veins we can treat in a session and maximize optimal results for a wider variety of superficial veins types,” says Boyle. The company is currently involved in initial IR B approved clinical studies at select locations in the US.
by Andrew Jones, MD and Ed Boyle, MD