VentureMed Group's Innovations in Vessel Preparation Unveiled
VentureMed Group, Inc., a leader in medical device innovations, has recently presented significant findings at a key symposium. Their FLEX Vessel Prep™ (VP) System is reshaping the landscape of arteriovenous (AV) access and peripheral arterial disease (PAD) procedures. With real-world data supporting its efficacy, this system is pivotal for maximizing patient outcomes while minimizing potential complications.
First Presentation: Insights from the FLEX FIRST AV Registry
A notable presentation led by Dr. Ari Kramer, a primary investigator from Spartanburg Medical Center, highlighted the FLEX FIRST AV Registry's 6-month findings. This multi-center observational study involved 130 hemodialysis patients dealing with AV fistula (AVF) or arteriovenous graft (AVG) complications. Dr. Kramer emphasized the system's transformative approach towards handling resistant stenoses.
"The FLEX VP System has changed the way I approach resistant stenoses. This study confirms what I've seen firsthand—controlled-depth micro-incisions offer not only technical precision but also a real clinical impact in reducing the need for repeat interventions," Dr. Kramer remarked.
The study's 6-month results showcased safe procedural practices and noteworthy durability in real-world scenarios. Key outcomes included:
- Zero serious adverse events were recorded within the one-month follow-up period.
- Overall target lesion primary patency reached 70.7% at 6 months.
- Cephalic Arch Lesion patency showed a remarkable 76.3%.
- Technical success of device delivery stood at an impressive 100% across all procedures.
Second Presentation: Enhancing Outcomes with Vessel Preparation
The subsequent presentation by Dr. Robert Shahverdyan focused on the importance of vessel preparation before drug-coated angioplasty. Dr. Shahverdyan's experience with over 70 patients revealed that using the FLEX system notably reduced reintervention rates compared to traditional methods.
"After using FLEX, the reintervention rates are markedly lower. The results are not just good; they reflect consistent performance across various access types and patient profiles," shared Dr. Shahverdyan.
The findings established the efficacy of vessel preparation before drug-coated balloon (DCB) procedures. Here are some of the critical results observed:
- Vessel Prep combined with DCB showed target lesion primary patency rates of 86.0% at 6 months and 73.6% at 12 months.
- Reinterventions per patient-year were significantly lower in the VP group (0.372) compared to traditional methods.
- In specific interventions, a staggering 75% of patients maintained their patency at 12 months with the VP approach.
- The results indicate that VP + DCB is a promising alternative for managing vascular access stenoses.
The Importance of FLEX in AV Access
Denis Harrington, President & CEO of VentureMed Group, expressed gratitude to the researchers involved: "We appreciate Dr. Kramer and Dr. Shahverdyan for their extensive research efforts. This data solidifies the foundation of evidence supporting the FLEX Vessel Prep device. Patients all over the globe deserve access to these advanced technologies and methodologies."
About VentureMed Group and the FLEX Vessel Prep™ System
VentureMed Group is dedicated to advancing endovascular solutions specifically designed for arteriovenous (AV) access and peripheral arterial disease (PAD) interventions. The FLEX Vessel Prep™ System employs the innovative Kinetic Endovascular Micro-incision Creation (KEMIC) technology, which stands apart from traditional balloon approaches. KEMIC's unique mechanism offers dynamic vessel apposition to produce precise micro-incisions, enhancing outcomes and reducing the risks associated with traditional methods.
This approach not only promotes luminal gain but also significantly improves drug absorption when combined with therapies, further lowering the risk of restenosis. FLEX is now FDA 510(k) cleared and CE Mark approved, indicating its readiness to redefine vessel preparation methodologies and improve treatment options for patients globally.
Frequently Asked Questions
What is the FLEX Vessel Prep™ System?
The FLEX Vessel Prep™ System is an advanced medical device designed to optimize vessel preparation using innovative micro-incision technology.
Who conducted the presentations on the FLEX Vessel Prep system?
The presentations were led by Dr. Ari Kramer and Dr. Robert Shahverdyan, both experts in vascular access and medical devices.
What were the key findings from the FLEX FIRST AV Registry?
The study indicated high rates of procedural safety with zero serious adverse events and a primary patency rate of 70.7% at 6 months.
What advantages does FLEX offer over traditional methods?
FLEX's controlled-depth micro-incisions lead to better clinical outcomes and reduced reinterventions compared to traditional balloon methods.
How has VentureMed Group contributed to vascular access treatments?
VentureMed Group has pioneered innovative technologies that enhance vascular access management and improve patient outcomes across different scenarios.
