Catheter therapy:

DELCATH USES CATHETER FOR
PRECISE DELIVERY OF CANCER
DRUGS
Delcath Systems  announced positive
clinical data for their proprietary liver
cancer treatment system, The Delcath
Percutaneous Hepatic Perfusion (PHP)
device.

The PHP system works by first isolating
the patient's liver from the rest of the
circulatory system. This is
accomplished using catheters and
balloons, which are inserted via small
incisions in the patient's neck and legs.
Highly-concentrated doses of
chemotherapy drugs are then
delivered directly to the diseased
organ. After treatment, the blood is
filtered and cleansed of potentially
toxic drugs and returned to circulation.

The system — which is unique as far
as we know — allows doctors to target
the liver with 10x higher doses of
chemotherapy than are normally
feasible. Since the drugs are targeted
directly at the tumors, then filtered out
of the bloodstream after treatment,
Delcath  thinks they can significantly
increase dosage without increasing
toxicity. It could prove to be an
important life-extending development
for patients who currently have few
treatment options.

Comparing treatment with the Delcath
PHP System with melphalan to Best
Alternative Care (BAC), based on
independent core lab review of patient
scans, the statistical analysis revealed
that the PHP patients had a statistically
significant longer median hPFS of 214
days compared to 70 days in the BAC
arm.
Trial no: NCT00324727


IN ATRIAL FIBRILLATION ABLATION
COMPARED TO MEDICATION
Pharmacologic therapy with anti-
arrhythmia drugs is the first line of
treatment for patients with symptomatic
atrial fibrillation. Today cardiac
electrophysiologists are increasingly
using catheter ablation to treat
patients with atrial fibrillation.  
The cardiac electrophysiologists at
NewYork-Presbyterian Hospital are
very experienced and highly skilled in
the use of catheter ablation to treat
patients with atrial fibrillation, with
some of the best outcomes in the
nation.

Drugs that can suppress atrial
fibrillation include flecainide,
propafenone, sotalol, dofetilide,
dronedarone, and amiodarone.

But in some patients, such drugs are
not sufficient, and catheter ablation
may be a therapeutic option. In
February 2009, the U.S. Food and
Drug Administration approved the first
ablation catheters designed
specifically for the treatment of
paroxysmal atrial fibrillation: the
NAVISTAR THERMOCOOL and EZ
Steer THERMOCOOL Nav Irrigated
Deflectable Diagnostic/Ablation
Catheters.

Using an endovascular approach,
radiofrequency catheter ablation uses
intense energy to destroy sleeves of
atrial tissue surrounding the pulmonary
veins, the source of the arrhythmia.
The "firewall" between the pulmonary
veins and left atrium created via
ablation results in a restoration of
normal heart rhythm.

In some patients, this firewall may
become compromised, and electrical
connections are re-established
between the pulmonary vein(s) and left
atrium, triggering a recurrence of the
arrhythmia. In these cases, a second
ablation procedure may be indicated,
usually several months after the initial
ablation.

A multicenter international study called
the Catheter Ablation versus Anti-
arrhythmic Drug Therapy for Atrial
Fibrillation (or CABANA) Trial will be
the largest study to date comparing
catheter ablation with pharmacologic
treatment for patients with atrial
fibrillation. Funded by the National
Heart, Lung, and Blood Institute, the
phase IV study is enrolling 3,000
patients who will be randomized to
have a catheter ablation procedure or
receive anti-arrhythmic drug therapy.
Trial no: NCT00911508


A NEW STUDY TESTING DR
ZAMBONI'S THEORY FOR MULTIPLE
SCLEROSIS
Dr Zamboni has  hypothesized that the
narrowing in the large veins in the
neck and chest might cause improper
drainage of blood from the brain,
resulting in eventual injury to brain
tissue is the cause of multiple sclerosis.
It is thought that angioplasty -- a
treatment commonly used by
cardiologists and other endovascular
surgeons to treat atherosclerosis --
may remedy the blockages.

Zamboni, an Italian doctor,  has
conducted preliminary studies that
suggest the efficacy of venous
angioplasty - "liberation procedure" --
in the amelioration of MS symptoms.

Now, researchers at the University at
Buffalo will launch PREMiSe  a study to
determine if endovascular intervention
via balloon angioplasty to correct the
blockages improves MS symptoms or
progression.

PREMiSe is believed to be the first
prospective randomized double-
blinded study of balloon angioplasty
for MS being performed with
Institutional Review Board approval in
a rigorous fashion in the US with
significant safeguards in place to
ensure careful determination of risks
and benefits.

The study is led by principal
investigator Adnan Siddiqui, MD,
assistant professor of Neurosurgery,
UB School of Medicine and Biomedical
Sciences, with co-principal
investigators Elad Levy, MD, associate
professor, and L.N. Hopkins, MD,
professor and chair of the UB
Department of Neurosurgery .

In the first phase of the study, ten MS
patients from the United States and
Canada who exhibit venous
insufficiency will undergo minimally
invasive venous angioplasties to
determine if the procedure can be
performed safely. The procedures
began June 29, performed by Siddiqui
and Levy at Kaleida Health's Millard
Fillmore Gates Hospital in Buffalo, New
York.


REPAIRING  HOLE IN THE HEART TO  
FIX MIGRAINE
A study is under way  to patch small
holes in hearts in order to fix migraine
headaches. The procedure is called
Patent Foramen Ovale and utilizes a
catheter to guide a small sheath of
fabric,  to cover both sides of the hole.


OTHER DEVELOPMENTS
Catheter ablation for Heart Atrial
Fibrillation equipment by C R Bard;

Angiojet by Possis Medical vacuums
out clots from veins;

Mammosite therapy by Cytyc;

Carotid stenting by Cordis;

Intradiscal Electro Thermal (IDET) for
low back pain;

Brain bypass technique for giant
aneurysm;

Brain aneurysm coiling;

Abdominal aneurysm stenting by Gore
Excluder;

VOYAGER Coronary Dilatation
(stretcher) Catheter with high-pressure
capability by Abbott;

Crosser catheter by Flowcardia
vibrates to break up plaque in patient’s
leg and heart arteries, it works by  
creating high frequency vibrations at
its tip that pulverize the plaque;

Wildcat catheter by Avinger Inc to
break up plaque in leg arteries;

Rotablation involves widening the
artery with a diamond-tipped rotating
burr, rather like a dentist’s drill;