Technology Update: Pipeline Medical Gets First-In-Man TMVR Implant & Gore Acquisition
By Adam Pick on November 4, 2019
In case you missed the big news…
W.L. Gore & Associates recently announced the acquisition of Pipeline Medical Technologies Inc. So you know, Pipeline manufactures a transcatheter mitral valve repair (TMVR) device that was founded by Dr. Steven Bolling, the Director of the Mitral Valve Program at Michigan Medicine and a long-time supporter of HeartValveSurgery.com.
Dr. Steven Bolling (Pipeline Founder)
In addition to its acquisition, I learned from Dr. Bolling that Pipeline just completed a “First-In-Man” implant of its TMVR solution. To learn more about Pipeline, I called Dr. Bolling.
Here are four highlights from my interview with Dr. Bolling:
1. What is the Pipeline device?
Pipeline is a chordal repair procedure for patients with degenerative mitral regurgitation (a leaking valve) via catheter. Similar to other transcatheter therapies, including transcatheter aortic valve replacement (TAVR), the Pipeline procedure does not require an incision to the patient’s chest and does not require the use of the heart lung machine. As a result, patients can avoid many of the risks associated with open heart surgery and recover faster.
“The data suggests that surgical mitral valve repair is the ‘gold standard’ for mitral valve surgery,” shared Dr. Bolling, “With Pipeline, we want to reproduce those results using transcatheter technologies. The challenge is that the mitral valve is very complex with potential issues across the annulus, the leaflets and the chords. Fixing the mitral valve is not as easy as replacing the valve.”
2. How does Pipeline repair mitral regurgitation?
As discussed in this post, a mitral valve that has defective chords can result in a severe backflow of blood. Over time, a leaking valve can cause multiple symptoms (shortness of breath, fatigue, chest pain, swollen ankles) and risks for patients (an enlarged heart, atrial fibrillation and heart failure) including death.
To fix the mitral chordae, the Pipeline device leverages a transfemoral and trasseptal chordal repair without open heart surgery. “With Pipeline, we’ve developed a new way to perform end-to-end chordal repair without surgery,” shared Dr. Bolling, “The other devices out there today are really surgery if you think about that. Pipeline will change that.”
To help you visualize how Pipeline works to fix broken chords on the mitral valve, Dr. Bolling sent me the amazing video below.
Pipeline Implant Animation Video
3. Why is a First-In-Man implant so important for a young company like Pipeline?
As mentioned above, the first Pipeline device was recently implanted in a patient. For young medical technology companies, this is often seen as a key milestone in their development.
“This is an important step for Pipeline,” Dr. Bolling stated, “We are now able to demonstrate that the science and technology within the Pipeline device can help patients. As you would expect, we learn an immense amount from each patient and are thankful to them.”
4. What’s next for Pipeline Following the Gore Acquisition?
In discussing the next steps for Pipeline, Dr. Bolling took a broader view of the industrial transformation that is happening specific to transcatheter technologies and valvular disease.
“The process of developing technologies that treat mitral valve disease using catheters is going to take a long time to perfect,” shared Dr. Bolling. “If you compare and contrast the development timeline of TMVR to TAVR, which is on its way to becoming the standard of care, I would estimate that we’re in about 2004. There is much to learn and much to do specific to mitral chordal repair, annulus reconstruction and replacement using catheters.”
That said, we will continue to monitor the development of Pipeline as an important piece of the TMVR evolution. Many thanks to Dr. Bolling for developing this new technology for patients needing help with their mitral regurgitation!
Keep on tickin!