Critical Limb Ischemia (CLI)
Critical Limb Ischemia is a loss of blood flow due to atherosclerosis in the leg that results in ischemic rest pain, nonhealing ischemic ulceration, or gangrene. CLI is the most advanced form of peripheral arterial disease (PAD) and affects patients with diabetes, coronary artery disease, and kidney disease. Even with treatment, many patients undergo amputations of the foot and lower leg.
23,000,000
Patients suffer from CLI worldwide
150,000
amputations each year in the US alone
0 FDA
approved drug delivery devices below-the-knee
Bringing safety and durability to angioplasty for CLI patients
Penello, SoundPipe’s drug delivery platform, addresses CLI by delivering drugs to provide safe, long-lasting blood flow. Penello delivers drugs like paclitaxel or sirolimus using drug-loaded microbubbles that are infused and localized by an intravascular ultrasound catheter. The combination of the ultrasound and microbubbles permeabilizes tissue to improve drug transfer into the tissue, reducing the drug dose required for a therapy by as much as 90%. The microbubbles are versatile drug carriers that can incorporate a variety of therapeutic compounds to treat a range of diseases.
how does penello work?
Penello is a platform technology that uses ultrasound activated drug carriers to provide patient-specific therapies and ensure optimal outcomes.
Angioplasty is performed to dilate the occluded artery and restore blood flow.
The Penello catheter is positioned in the artery and microbubbles are infused through the Penello catheter.
The Penello catheter generates ultrasonic waves that direct the microbubbles to the treatment site, effectively "painting" the artery with drug.
Additional ultrasonic waves from the Penello catheter release the drug from the microbubbles and enhance the permeability of the surrounding tissue. In CLI patients, the drugs paclitaxel and sirolimus can be delivered to prolong the effectiveness of angioplasty.
The Penello catheter can be repositioned and the process repeated to treat multiple arteries, a common need for CLI patients.
Better drug delivery differentiates Penello
Increase
Uptake of hard to deliver therapeutics.
Reduce
The dose of dangerous and expensive therapeutics.
Save
Time and money with a versatile, single catheter platform to treat multiple lesions.