Potential Breakthrough Targeted Drug Delivery in Cancer Treatment

IsoFlow™, an infusion catheter designed for the direct delivery of medication into highly targeted areas, may be an important breakthrough for the treatment of patients with cancer.

The concept of IsoFlow Infusion catheter is developed by Robert Goldman, founder of Vascular Designs, a medical device company based in San Jose, CA. The company today announced that it has secured 510(k) marketing clearance by the U.S. Food and Drug Administration (FDA) for this device.

The IsoFlow Infusion catheter enables sideways perfusion, which allows physicians to precisely target and isolate areas within the body where the infused drugs are delivered. With IsoFlow's unique design, medications can be delivered into areas that could not previously be treated directly, for instance, a cancerous tumor. According to numerous studies, this approach lets physicians increase drug concentrations at targeted sites while reducing systemic exposure, thereby improving efficacy and patient outcomes when treating illnesses such as cancer with chemotherapy.

"In select clinical situations, the benefits of delivering a local endovascular drug dose without systemic exposure can reduce complications, improve results, and benefit patients," said Dr. Michael Dake, former chief of interventional radiology and current professor of cardiothoracic surgery at Stanford University School of Medicine. "The IsoFlow catheter facilitates the use of regional infusion therapies, especially in cases of challenging arterial anatomy where it helps achieve these promises of targeted delivery. IsoFlow is a valuable addition to our treatment arsenal."

IsoFlow is a dual balloon catheter designed to isolate a specific treatment region within the body from blood flow. It allows the infusion of fluids into the region and the perfusion of blood past the region to keep the blood flow intact during treatment. One of the many unique features of the IsoFlow infusion catheter is the ability to deliver medications sideways while using pressure to push the medication into the targeted area. The IsoFlow catheter is inserted over a guide wire for precise positioning within a patient's body. Once in place, medication is infused and isolated when both of the catheter's balloons are simultaneously inflated using fluid via a single inflation lumen.

"We are thrilled to receive FDA 510(k) marketing clearance after working on the IsoFlow catheter for more than seven years," said Robert Goldman, CEO and founder of Vascular Designs. "But what is most important is that individuals battling life-threatening illnesses will have a breakthrough treatment option to pursue with highly targeted drug delivery."

"IsoFlow could have a huge impact on the way many of today's deadliest illnesses such as cancer are treated. This method of local delivery may cause tumors that were previously unresponsive to systemic chemotherapy to respond. Additionally, the IsoFlow catheter may be able to provide treatment for a number of other medical conditions for which local delivery would be an ideal option," continued Goldman. "The potential applications of IsoFlow are exciting. We are looking forward to seeing how physicians will leverage this breakthrough catheter medical device into practice and the impact that it will surely make on the prognosis of so many patients."

Vascular Designs has received FDA 510(k) marketing clearance for IsoFlow, which enables the direct delivery of medications into targeted areas. An important application for the IsoFlow catheter may be in the treatment of cancer.

For more information:

• Click here to view an animation detailing this IsoFlow Infusion catheter process

Also read these articles:

• Chrysos, E., et al. Treatment of Unrescectable Malignant Abdominal, Pelvic and Thoracic Tumors Using Abdominal Pelvic and Thoracic Stop-flow Chemotherapy. Anticancer Research, Sept.-Oct. 2001. 21(5):3669-3675.
• Collins, J.M., Pharmacologic Rationale for Regional Drug Delivery. Journal of Clinical Oncology, Vol. 2, 498-504. 1984.
• Lygidakis, N.J., Sgourakis, G. and Aphinives, P. Upper Abdominal Stop-flow Perfusion as a Neo and Adjuvant Hypoxic Regional Chemotherapy for Resectable Gastric Carcinoma: A Prospective Randomized Clinical Trial. Hepatogastroenterology, May-Jun. 1999. 46(27): 2035-2038.
• Miotto, D., et al. Hypoxic Antiblastic Stop-flow Perfusion: Clinical Outcome and Pharmacokinetic Findings. Journal of Chemotherapy, Nov. 16, 2004. Suppl. 5: 44-47.
  Pilati, P., et al. Stop-flow Technique for Loco-regional Delivery of Antiblastic Agents: Literature Review and Personal Experience. European Journal of Surgical Oncology, Aug. 28, 2002. 544-553.